Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202108532761448 Date of Approval: 05/08/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title GBT2104-133(C5361003)
Official scientific title An Open-label Extension Study to Evaluate the Long-term Safety of Inclacumab Administered to Participants with Sickle Cell Disease Who Have Participated in an Inclacumab Clinical Trial
Brief summary describing the background and objectives of the trial This study is a multicenter, global, open-label extension study to assess the safety of long-term use of inclacumab in participants with sickle cell disease (SCD). Additional objectives are to evaluate the incidence of vaso-occlusive crises (VOCs), hospitalizations, missed work/school days, red blood cell (RBC) transfusions, and quality of life (QoL) with long-term use of inclacumab. The study will include participants with SCD who have completed a prior Global Blood Therapeutics, Inc. (GBT)-sponsored inclacumab clinical study (originating study) and meet eligibility criteria. Up to approximately 520 participants with SCD will be enrolled. All participants will receive inclacumab 30 mg/kg administered intravenously every 12 weeks. The primary objective of this study is to evaluate the long-term safety of every 12-week dosing of inclacumab in participants with SCD who have completed a prior inclacumab clinical trial.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Haematological Disorders,Infections and Infestations
Sub-Disease(s) or condition(s) being studied Sickle Cell Disease
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/10/2021
Actual trial start date 29/03/2022
Anticipated date of last follow up 31/12/2028
Actual Last follow-up date
Anticipated target sample size (number of participants) 520
Actual target sample size (number of participants) 242
Recruitment status Closed to recruitment,follow-up continuing
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Single Group Non-randomised Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Inclacumab 30 mg/kg every 12 weeks (Q12W) The study will continue with every 12-week visits for dosing if participants continue to receive clinical benefit that outweighs risk, as determined by the Investigator, until the participant has access to inclacumab from an alternative source (eg, through commercialization or a managed-access program). Eligible participants will receive open-label inclacumab for 12 weeks 242
Control Group Not Applicable Zero Not Applicable Not applicable 0 Historical
Experimental Group Inclacumab 30 mg/kg every 12 weeks (Q12W) The study will continue with every 12-week visits for dosing if participants continue to receive clinical benefit that outweighs risk, as determined by the Investigator, until the participant has access to inclacumab from an alternative source (eg, through commercialization or a managed-access program). Eligible participants will receive open-label inclacumab for 12 weeks 242
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Inclusion Criteria Participants who meet all the following criteria will be eligible for study enrollment: 1. Male or female participant with SCD who participated and received study drug in a GBT-Sponsored inclacumab clinical study. 2. Participant has completed the originating inclacumab study within 30 days prior to the Day 1 Visit. Participants who discontinued study drug in the originating study due to a non-study drug-related adverse event (AE), but who remained on study, may be eligible for treatment in this study provided the AE does not pose a risk for treatment with inclacumab. 3. Female participants of childbearing potential are required to have a negative urine pregnancy test (UTP) prior to dosing on Day 1. Note: Female participants who become childbearing during the study must be willing to have a negative UPT to remain in the study. 4. If sexually active, female participants of childbearing potential must use highly effective methods of contraception until 165 days after the last dose of study drug. If sexually active, male participants must use barrier methods of contraception until 165 days after the last dose of study drug. 5. Participant has provided written informed consent/assent. For underage (i.e., ≤ 18 years of age) participants, both the consent of the participant’s legal representative or legal guardian and the participant’s assent (where applicable) must be obtained based on local requirement. Exclusion Criteria Participants meeting any of the following exclusion criteria will not be eligible for study enrollment: 1. Female participant who is breastfeeding or pregnant. 2. Participant had an infusion-related reaction (IRR) in the originating inclacumab clinical study. 3. Participant withdrew consent from the originating inclacumab clinical study. 4. Participant was lost to follow-up from the originating inclacumab clinical study. 5. Participant has any medical, psychological, safety, or behavioral conditions that, in the opinion of the Investigator, may confound safety interpretation, interfere with compliance, or preclude informed consent. 80 and over: 80+ Year,Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Child: 6 Year-12 Year,Middle Aged: 45 Year(s)-64 Year(s) 12 Year(s) 85 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 19/09/2022 KEMRI SERU
Ethics Committee Address
Street address City Postal code Country
Off Mbagathi Road Nairobi 00200 Kenya
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 19/09/2022 KEMRI scientific and Ethics review Unit
Ethics Committee Address
Street address City Postal code Country
P.O. Box 54840-00200, Nairobi Nairobi 00200 Kenya
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 02/09/2021 KEMRI Scientific and Ethics Review Unit
Ethics Committee Address
Street address City Postal code Country
P.O. Box 54840-00200 Nairobi 00200 Kenya
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 11/02/2022 KEMRI scientific and Ethics Review unit
Ethics Committee Address
Street address City Postal code Country
P.O. Box 54840-00200, Nairobi Nairobi 00200 Kenya
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 21/06/2022 Gertrudes Childrens Hospital
Ethics Committee Address
Street address City Postal code Country
34, Muthaiga Rd Nairobi Nairobi 00100 Kenya
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 26/10/2021 National Institute for Medical Research
Ethics Committee Address
Street address City Postal code Country
P.O. Box 9653 11101 Dar es Salaam, 3 Barack Obama Drive Dar es Salam 11101 Tanzania
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 14/03/2022 Komfo Anokye Teaching Hospital Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
P.O.Box 1934 Kumasi, Ashanti, Ghana Ashanti 1934 Ghana
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 08/10/2021 University of Zambia Biomedical Research Ethics committee
Ethics Committee Address
Street address City Postal code Country
Ridgeway campus PO Box 50110 Lusaka 44370 Zambia
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 27/01/2022 ERES CONVERGE IRB
Ethics Committee Address
Street address City Postal code Country
Olive Tree Mean Wood road Lusaka Lusaka Zambia
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 11/01/2022 ERES CONVERGE IRB
Ethics Committee Address
Street address City Postal code Country
Olive Tree Mean Wood road Lusaka Lusaka Zambia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary objective of this study is to evaluate the long-term safety of every 12-week dosing of inclacumab in participants with SCD that have completed a prior inclacumab clinical trial. Throughout the study
Secondary Outcome Additional objectives are to evaluate the incidence of VOCs, hospitalizations, missed work/school days, RBC transfusions, and quality of life (QoL) with long-term use of inclacumab. Throughout the study
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
KEMRI CRDR SIAYA Clinical Research Annex Siaya County Hospital Siaya 144-40600 Kenya
National Hospital Abuja Central Business District Abuja Nigeria
American University of Beirut Medical Center American University Of Beirut Medical Center Beirut 11-0236 Lebanon
Hospital Henri Mondor 51 Avenue Marechal De Lattre De Tassigny Creteil 94010 France
Dana Farber Cancer Institute 4500 Brookline Avenue, Mayer 446 Boston 2215 United States of America
St Jude Childrens Research Hospital Dmid-ctm Not required for Low Risk Dmidctm 333 United States of America
Cukurova University Medical Faculty Balcali Hospital Balcali Remzioguzarik 1250 Turkey
University of South Florida 12901 Bruce B. Downs Blvd Tampa 33612 United States of America
Zagazig University Hospitals Faculty Of Medicine, Block E, 1st Floor, Room 331 Mangaung 9300 South Africa
Al Kasr Al Ainy Cairo University Hospital Al Manial, Cairo Governorate Elmanial Egypt
University of Illinois at Chicago 1740 West Talylor Street Chicago 60612 United States of America
Ain Shams University Hospital Address Unknown City Unknown Egypt
E O Ospedali Galliera Mura Delle Cappuccine, 14 Genova 16128 Italy
Hospital Avicenne 125 Rue de Stalingrad Bobigny 93009 France
Jacobi Medical Center 111 E 210th St Bronx 2 United States of America
Childrens Hospital of Orange County 455 S Main St Orange 928683835 United States of America
DMC Detroit Receiving Hospital 4201 Saint Antoine St Detroit 482012153 United States of America
Arkansas Childrens Hospital 1 Childrens Way Little Rock 722023500 United States of America
Azienda Ospedale Universita Padova Via Giustiniani 3 Padova 35128 Italy
University of Michigan 3912 Taubman Center, 1500 East Medical Center Drive Ann Arbour 48109 United States of America
Strathmore University Medical centre PO Box 59857-00200 Nairobi 00200 Kenya
Universitatsklinikum Freiburg Hugstetter Str. 55 Freiburg 79106 Germany
University Clinic Regensburg Franz-Joseph-Strauss-Allee 11 Regensburg 93053 Germany
AOU dellUniversita degli Studi della Campania Luigi Vanvitelli Via Luigi De Crecchio 4 Napoli 80138 Italy
Centre Hospitalier Intercommunal 40 Avenue De Verdun Creteil 94010 France
Aflac Cancer and Blood Disorders Center 1001 Johnson Ferry Road Atlanta 303421605 United States of America
Matero Clinical Research Site Off Alick Nkhata Road Lusaka 10101 Zambia
Sociedad de Oncologia y hematologia del Cesar Ltda Carrera 15 14 91 Valledupar 200001 Colombia
CHU de Toulouse IUCT ONCOPOLE 1 Avenue Irene Joliot Curie Toulouse 31100 France
Nini Hospital Achier El Daya Tarablus Lebanon
Organizacion Clinica Bonnadona Prevenir S.A.S Carrera 49 C 82-70 Torre Administrativa Piso 2 Barranquilla 180020 Colombia
Kings College Hospital Denmark Hill London SE5 9RS United Kingdom
Gertrudes Childrens Hospital 34 Muthaiga Rd Nairobi 00100 Kenya
Aminu Kano Teaching Hospital 11399 P Close Zaria Road Lagos 3452 Nigeria
University of Nigeria Kwame Nkuruma Way Enugu Nigeria
Lagos University Teaching Hospital Haematology PO Box 12003 Surulere 101014 Nigeria
University of Abuja Teaching Hospital PMB 117 Gwagwalada FCT Abuja Nigeria
National Hospital Abuja Central Business District Abuja Nigeria
University of Calabar Teaching Hospital PMB 1278 Calabar Nigeria
Sultan Qaboos University Hospital 35 Alkoudh Al Koudh 123 Oman
Sultan Qaboos University Hospital 35 Alkoudh Al Khoudh 123 Oman
International Cancer Institute P.O Box 8088 Eldoret 30100 Kenya
NIMR Mbeya Medical Research Center Hospital Hill Road Mbeya United Republic of Tanzania
Komfo Anokye Teaching Hospital KATH Office of Dean/Department of Child Health Kumasi Ghana
KEMRI CRDR Clinical Research Clinic Nairobi Off Hospital Road Nairobi 00100 Kenya
Kasr El Aini Hospital Address Unknown City Unknown Egypt
Clinica De La Costa PPDS Carrera 50 Numero 80-90 Barranquilla 80020 Colombia
NIMR Mbeya Medical Research Center Hospital Hill Road Dar es Slam 53107 Tanzania
The University Teaching Hospital Childrens Hospital RW 1X , Nationalist Road Lusaka 10101 Zambia
Arthur Davison Childrens Hospital Corner Chiwanangala and Boundary Roads, Northrise Ndola 10101 Zambia
FUNDING SOURCES
Name of source Street address City Postal code Country
Global Blood Therapeutics Inc. a wholly owned subsidiary of Pfizer Inc. 181 Oyster Point Blvd South San Francisco 94080 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor A wholly owned subsidiary of Pfizer Inc 181 Oyster Point Blvd South San Francisco CA94080 United States of America Pharma Company
COLLABORATORS
Name Street address City Postal code Country
Miguel Abboud American University Of Beirut Medical Center Beirut 110236 Lebanon
Pablo Bartolucci 51, Avenue Marechal De Lattre De Tassigny, Service Doncologie Medicale Creteil 94010 France
Maureen Achebe 4500 Brookline Avenue, Mayer 446 Boston 2215 United States of America
Jeremie Estepp Dmid-ctm Not Required For Low Risk Dmid 333 United States of America
Ali Bulent Antmen Balcali Remzioguzarik 1250 Turkey
Juan Rico 12901 Bruce B.Downs Blvd Tampa 33612 United States of America
Mohamed Badr Faculty of Medicine Mangaung 9300 South Africa
Almal ElBeshlawy Kasr Al Ainy University Hospital Elmanial Egypt
Santosh Saraf 1740 West Talylor Street Chicago 60612 United States of America
Fatma Ebeid Address unknown Unknown Egypt
Gian Luca Forni Mura Delle Cappuccine 14 Genova 16128 Italy
Sylvain Le Jeune 125 Rue de Stalingrad Bobigny 93009 France
Kenneth Rivlin 111 E 210th Street Bronx 10467 United States of America
Carolyn Suzanne Saccente 1 Childrens Way Little Rock 722023350 United States of America
Raffaella Colombatti Via Giustiniani 3 Padova 35128 Italy
Ghada Abusin 3912 Taubman Center 1500 East Medical Center Drive Ann Arbor 48109 United States of America
Bernhards Ogutu Ole Sangale Road, Madaraka Estate Nairobi 00200 Kenya
Miriam Erlacher Hugstetter Street 55 Freiburg 79106 Germany
Selim Corbacioglu Franz Joseph Strauss Allee 11 Regensburg 93053 Germany
Silvero Perrotta Via Luigi De Crecchio 4 Napoli 80138 Italy
Corinne Pondarre 40 Avenue De Verdun Creteil 94010 France
Robert Clark Brown 1001 Johnson Ferry Rd Atlanta 30342 United States of America
Roma Chilengi Off Alick Nkhata Road Lusaka 10101 Zambia
Carmen Rosales Carrera 15 14 91 Valledupar 200001 Colombia
Pierre Cougoul 1 Avenue Irene Joliot Curie Toulouse 31100 France
Inati Lebanon Achier El Daya Tarablus Lebanon
Marla Saenz Rojas Carrera 49 C 82-70 Torre Administrativa Piso 2 Barranquilla 180020 Colombia
Moji Awogbade Denmark Hill London SE5 9RS United Kingdom
Jessie Githanga 34 Muthaiga Rd Nairobi 00100 Kenya
Shehu Abdullahi P Close Zaria Road Lagos 3452 Nigeria
Iheanyi Okpala Kwame Nkuruma Way Enugu Nigeria
Adeseye Akinsete PO Box 12003 Enugu Nigeria
Obiageli Nnodu PMB 117 Gwagwalada FCT Abuja Nigeria
Oluseyi Oniyangi Central Business District Abuja Nigeria
Martin Meremikwu PMB 1278 Calabar Nigeria
Salam Alkindi 35 Alkoudh Alkoudh 123 Oman
Yasser Wali 35 Alkoudh Alkoudoh 123 Oman
Frederick Chite PO Box 8088 Eldoret Gpo 30100 Kenya
Issa Sabi Hospital Hill Road Mbeya Tanzania
Videlis Nduba Siaya County Hospital Siaya 144-40600 Kenya
Alex OseiAkoto Office of Dean Dept of Child Health Kumasi Ghana
Videlis Nduba Off hospital road Nairobi 00100 Kenya
Mona Hamdy Mahmoud Unknown Unknown Egypt
Fausto Vitali Carrera 50 Numero 80 90 Barranquilla 80020 Colombia
Dr. Chunda Liyoka Nationalist Road Lusaka 10101 Zambia
Dr. Mwansa Jonathan Corner Chiwanangala and Boundary Roads, Northrise Ndola 10101 Zambia
Pakbaz Zahra 101 the City Dr South Orange 92868-320 United States of America
Videlis Nduba Kenyatta Hospital complex Off hospital Road Nairobi 0100 Kenya
Unal Sule Hacettepe Gevher Ankara 6230 Turkey
Cancado Rodolfo Rua Conselheiro Brotero, 1486 Sao Paulo 01232-010 Oman
Cavalheiro Rita de Cassia Rua Santa Marcelina, 177 Sao Paulo 08270-070 Brazil
Marri Preethi 1700 Center St Mobile 36604-330 United States of America
Moura Patricia Rua Frei Caneca, 8 Rio De Janeiro 20211-030 Brazil
Idowu Modupe 6431 Fannin St Houston 77030-150 United States of America
Telen Marilyn 2301 Erwin Rd Durham 27705-469 United States of America
Alvarenga Laine Avenida Sao Rafael 2152 6 Andar Salvador 41253-196 Brazil
Friedrisch Joao Ricardo Rua Ramiro Barcelos, 2350 Porto Alegre 90035-003 Brazil
Bello Manga Halima Lafiya Road, City Centre Kaduna 800212 Nigeria
Ozdogu Hakan Kisla Saglik Yerleskesi Gulh Adana 1123 Turkey
Malhan Hafiz 2034 King Abdul Aziz Rd Jazan 82943 Saudi Arabia
Andemariam Biree 263 Farmington Ave Farmington 06030-000 United States of America
Silva Pinto Ana Cristina Avenida Bandeirantes 3900 Ribeirao Preto 14048-900 Brazil
Waziri Aliyu Kaduna state, PMB 06 Zaria 810107 Nigeria
Lorenzetti Alexandre Avenida Brigadeiro Faria Lima, 5546 Sao Jose Do Rio Preto 15090-000 Brazil
Inati Adlette Al Maarad Street 1434 Lebanon
da Silva Araujo Aderson Rua Senador Jose Henrique 231 Recife 50070-460 Brazil
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Videlis Nduba vnduba@gmail.com +254724522474 KEMRI CRDR Cinical Research Annex
City Postal code Country Position/Affiliation
Nairobi 00100 Kenya Medical Doctor
Role Name Email Phone Street address
Public Enquiries Margot Hottmann mhottmann@gbt.com +0016508228728 181 Oyster Point Blvd
City Postal code Country Position/Affiliation
South San Francisco CA94080 United States of America Sr Clinical Trial Manager
Role Name Email Phone Street address
Scientific Enquiries Carolyn Hoppe choppe@pfizer.com +0016508228728 181 Oyster Point Blvd
City Postal code Country Position/Affiliation
South San Francisco CA94080 United States of America Sr. Director Medical Affairs
Role Name Email Phone Street address
Scientific Enquiries Carolyn Hoppe choppe@pfizer.com +0016508228728 181 Oyster Point Blvd
City Postal code Country Position/Affiliation
South San Francisco CA94080 United States of America Sr. Director Medical Affairs
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Trial result summaries will be shared when the final clinical study report is available. The method of sharing the information is still to be determined across the entire program of studies. Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol When the Clinical Study Report is final To be confirmed.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Public title 08/04/2024 Added due to Sponsor Acquisition, from GBT to Pfizer GBT2104-133 GBT2104-133(C5361003)
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial description 09/07/2021 Data entry update. This study is a multicenter, global, open-label extension, study to assess the safety of long-term use of inclacumab in participants with SCD. The incidence of VOCs, hospitalizations, days missed from school/work, RBC transfusions, and QoLassessments will also be collected. The study will include participants with SCD who have completed a prior GBT sponsored inclacumab clinical study (originating study) and meet eligibility criteria. Up to approximately 520 participants with SCD will be enrolled. All participants will receive inclacumab 30 mg/kg administered intravenously every 12 weeks.The primary objective of this study is to evaluate the long-term safety of every 12-week dosing of inclacumab in participants with sickle cell disease (SCD) who have completed a prior inclacumab clinical trial. Additional objectives are to evaluate the incidence of vaso-occlusive crises (VOCs), hospitalizations, missed work/school days, red blood cell (RBC) transfusions, and quality of life (QoL) with long-term use of inclacumab. This study is a multicenter, global, open-label extension, study to assess the safety of long-term use of inclacumab in participants with sickle cell disease (SCD). The incidence of vaso-occlusive crises (VOCs), hospitalizations, days missed from school/work, (red blood cell) RBC transfusions, and Quality of Life (QoL) assessments will also be collected. The study will include participants with SCD who have completed a prior GBT sponsored inclacumab clinical study (originating study) and meet eligibility criteria. Up to approximately 520 participants with SCD will be enrolled. All participants will receive inclacumab 30 mg/kg administered intravenously every 12 weeks. The primary objective of this study is to evaluate the long-term safety of every 12-week dosing of inclacumab in participants with SCD who have completed a prior inclacumab clinical trial. Additional objectives are to evaluate the incidence of VOCs, hospitalizations, missed work/school days, red RBC transfusions, and QoL with long-term use of inclacumab.
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial description 16/07/2021 Information updated This study is a multicenter, global, open-label extension, study to assess the safety of long-term use of inclacumab in participants with sickle cell disease (SCD). The incidence of vaso-occlusive crises (VOCs), hospitalizations, days missed from school/work, (red blood cell) RBC transfusions, and Quality of Life (QoL) assessments will also be collected. The study will include participants with SCD who have completed a prior GBT sponsored inclacumab clinical study (originating study) and meet eligibility criteria. Up to approximately 520 participants with SCD will be enrolled. All participants will receive inclacumab 30 mg/kg administered intravenously every 12 weeks. The primary objective of this study is to evaluate the long-term safety of every 12-week dosing of inclacumab in participants with SCD who have completed a prior inclacumab clinical trial. Additional objectives are to evaluate the incidence of VOCs, hospitalizations, missed work/school days, red RBC transfusions, and QoL with long-term use of inclacumab. This study is a multicenter, global, open-label extension, study to assess the safety of long-term use of inclacumab in participants with sickle cell disease (SCD). The incidence of vaso-occlusive crises (VOCs), hospitalizations, days missed from school/work, (red blood cell) RBC transfusions, and Quality of Life (QoL) assessments will also be collected. The study will include participants with SCD who have completed a prior Global Blood Therapeutics, Inc. (GBT) sponsored inclacumab clinical study (originating study) and meet eligibility criteria. Up to approximately 520 participants with SCD will be enrolled. All participants will receive inclacumab 30 mg/kg administered intravenously every 12 weeks. The primary objective of this study is to evaluate the long-term safety of every 12-week dosing of inclacumab in participants with SCD who have completed a prior inclacumab clinical trial. Additional objectives are to evaluate the incidence of VOCs, hospitalizations, missed work/school days, red RBC transfusions, and QoL with long-term use of inclacumab.
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial description 21/07/2021 Data entry updated This study is a multicenter, global, open-label extension, study to assess the safety of long-term use of inclacumab in participants with sickle cell disease (SCD). The incidence of vaso-occlusive crises (VOCs), hospitalizations, days missed from school/work, (red blood cell) RBC transfusions, and Quality of Life (QoL) assessments will also be collected. The study will include participants with SCD who have completed a prior Global Blood Therapeutics, Inc. (GBT) sponsored inclacumab clinical study (originating study) and meet eligibility criteria. Up to approximately 520 participants with SCD will be enrolled. All participants will receive inclacumab 30 mg/kg administered intravenously every 12 weeks. The primary objective of this study is to evaluate the long-term safety of every 12-week dosing of inclacumab in participants with SCD who have completed a prior inclacumab clinical trial. Additional objectives are to evaluate the incidence of VOCs, hospitalizations, missed work/school days, red RBC transfusions, and QoL with long-term use of inclacumab. This study is a multicenter, global, open-label extension study to assess the safety of long-term use of inclacumab in participants with sickle cell disease (SCD). Additional objectives are to evaluate the incidence of vaso-occlusive crises (VOCs), hospitalizations, missed work/school days, red blood cell (RBC) transfusions, and quality of life (QoL) with long-term use of inclacumab.. The study will include participants with SCD who have completed a prior Global Blood Therapeutics, Inc. (GBT)-sponsored inclacumab clinical study (originating study) and meet eligibility criteria. Up to approximately 520 participants with SCD will be enrolled. All participants will receive inclacumab 30 mg/kg administered intravenously every 12 weeks. The primary objective of this study is to evaluate the long-term safety of every 12-week dosing of inclacumab in participants with SCD who have completed a prior inclacumab clinical trial. Additional objectives are to evaluate the incidence of VOCs, hospitalizations, missed work/school days, red RBC transfusions, and QoL with long-term use of inclacumab.
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial description 22/07/2021 Update to data entry. This study is a multicenter, global, open-label extension study to assess the safety of long-term use of inclacumab in participants with sickle cell disease (SCD). Additional objectives are to evaluate the incidence of vaso-occlusive crises (VOCs), hospitalizations, missed work/school days, red blood cell (RBC) transfusions, and quality of life (QoL) with long-term use of inclacumab.. The study will include participants with SCD who have completed a prior Global Blood Therapeutics, Inc. (GBT)-sponsored inclacumab clinical study (originating study) and meet eligibility criteria. Up to approximately 520 participants with SCD will be enrolled. All participants will receive inclacumab 30 mg/kg administered intravenously every 12 weeks. The primary objective of this study is to evaluate the long-term safety of every 12-week dosing of inclacumab in participants with SCD who have completed a prior inclacumab clinical trial. Additional objectives are to evaluate the incidence of VOCs, hospitalizations, missed work/school days, red RBC transfusions, and QoL with long-term use of inclacumab. This study is a multicenter, global, open-label extension study to assess the safety of long-term use of inclacumab in participants with sickle cell disease (SCD). Additional objectives are to evaluate the incidence of vaso-occlusive crises (VOCs), hospitalizations, missed work/school days, red blood cell (RBC) transfusions, and quality of life (QoL) with long-term use of inclacumab. The study will include participants with SCD who have completed a prior Global Blood Therapeutics, Inc. (GBT)-sponsored inclacumab clinical study (originating study) and meet eligibility criteria. Up to approximately 520 participants with SCD will be enrolled. All participants will receive inclacumab 30 mg/kg administered intravenously every 12 weeks. The primary objective of this study is to evaluate the long-term safety of every 12-week dosing of inclacumab in participants with SCD who have completed a prior inclacumab clinical trial.
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial type 15/06/2021 Data entry error RCT CCT
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Actual trial start date 15/11/2024 New information added 29 Mar 2022
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Final no of participants 15/11/2024 New information added 242
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 15/11/2022 Recruitment status update Not yet recruiting Recruiting
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 15/11/2024 Updated information Recruiting Closed to recruitment,follow-up continuing
Section Name Field Name Date Reason Old Value Updated Value
Study Design Intervention assignment 08/04/2024 wrong data entry Parallel: different groups receive different interventions at same time during study Single Group
Section Name Field Name Date Reason Old Value Updated Value
Study Design Allocation to intervention 11/06/2021 Study team has confirmed that there is no randomization on this trial. Randomised Non-randomised
Section Name Field Name Date Reason Old Value Updated Value
Study Design Allocation concealment 11/06/2021 No randomization on this trial Central randomisation by phone/fax
Section Name Field Name Date Reason Old Value Updated Value
Study Design Allocation concealment 15/06/2021 Data entry error Allocation was determined by the holder of the sequence who is situated off site
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Inclusion criteria 08/04/2024 due to protocol amendment clarification Inclusion Criteria Participants who meet all the following criteria will be eligible for study enrollment: 1. Male or female participant with SCD who participated and received study drug in a GBT-Sponsored inclacumab clinical study. 2. Participant has completed the originating inclacumab study within 30 days prior to the Day 1 Visit. Participants who discontinued study drug in the originating study due to a non-study drug-related adverse event (AE), but who remained on study, may be eligible for treatment in this study provided the AE does not pose a risk for treatment with inclacumab. 3. Female participants of childbearing potential are required to have a negative urine pregnancy test prior to dosing on Day 1. Note: Female participants who become childbearing during the study must be willing to have a negative urine pregnancy test to remain in the study. 4. If sexually active, female participants of childbearing potential must use highly effective methods of contraception until 165 days after the last dose of study drug. If sexually active, male participants must use barrier methods of contraception until 165 days after the last dose of study drug. 5. Participant has provided written informed consent/assent. For underage participants, both the consent of the participant’s legal representative or legal guardian and the participant’s assent (where applicable) must be obtained based on local requirement. Inclusion Criteria Participants who meet all the following criteria will be eligible for study enrollment: 1. Male or female participant with SCD who participated and received study drug in a GBT-Sponsored inclacumab clinical study. 2. Participant has completed the originating inclacumab study within 30 days prior to the Day 1 Visit. Participants who discontinued study drug in the originating study due to a non-study drug-related adverse event (AE), but who remained on study, may be eligible for treatment in this study provided the AE does not pose a risk for treatment with inclacumab. 3. Female participants of childbearing potential are required to have a negative urine pregnancy test (UTP) prior to dosing on Day 1. Note: Female participants who become childbearing during the study must be willing to have a negative UPT to remain in the study. 4. If sexually active, female participants of childbearing potential must use highly effective methods of contraception until 165 days after the last dose of study drug. If sexually active, male participants must use barrier methods of contraception until 165 days after the last dose of study drug. 5. Participant has provided written informed consent/assent. For underage (i.e., ≤ 18 years of age) participants, both the consent of the participant’s legal representative or legal guardian and the participant’s assent (where applicable) must be obtained based on local requirement.
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Age group 08/06/2021 Correction to include the minimum age of 18 years and the maximum age of 65 years. Adult: 19 Year-44 Year, Middle Aged: 45 Year(s)-64 Year(s) Adolescent: 13 Year-18 Year, Adult: 19 Year-44 Year, Middle Aged: 45 Year(s)-64 Year(s), Aged: 65+ Year(s)
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Age group 17/06/2021 Data entry error Adolescent: 13 Year-18 Year, Adult: 19 Year-44 Year, Middle Aged: 45 Year(s)-64 Year(s), Aged: 65+ Year(s) Child: 6 Year-12 Year, Adolescent: 13 Year-18 Year, Adult: 19 Year-44 Year, Middle Aged: 45 Year(s)-64 Year(s), Aged: 65+ Year(s), 80 and over: 80+ Year
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 15/06/2021 Data entry error Control Group, Inclacumab, 30 mg/kg every 12 weeks (Q12W), The study will continue until all participants are no longer participating in the study or until the Sponsor determines that the study should be discontinued due to safety or other reasons, Eligible participants will receive open-label inclacumab on Day 1. It is intended that Day 1 coincides with the final visit from the originating inclacumab study. End of Study assessments from the originating study will serve as Baseline assessments for this study. If Day 1 does not occur on the same day, the Day 1 Visit must occur within 30 calendar days of completion of the originating study. If Day 1 for this study is greater than 7 days from the completion of the originating study, new Baseline assessments will be obtained. Participants will return to the clinical site 6 weeks after administration of the first inclacumab dose for safety assessments. They will then return every 12 weeks after the Day 1 dose administration for inclacumab administration, safety assessments, and collection of VOC events. Collection of QoL assessments and days missed from school/work will be collected at these visits. The study will continue with every 12-week visits for dosing if participants continue to receive clinical benefit that outweighs risk, as determined by the Investigator, until the participant has access to inclacumab from an alternative source (eg, through commercialization or a managed-access program)., 520, Uncontrolled
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 15/06/2021 Data entry error Experimental Group, Inclacumab, All participants will receive inclacumab 30 mg/kg administered intravenously., Every 12 weeks, Eligible participants will receive open-label inclacumab on Day 1. It is intended that Day 1 coincides with the final visit from the originating inclacumab study. End of Study assessments from the originating study will serve as Baseline assessments for this study. If Day 1 does not occur on the same day, the Day 1 Visit must occur within 30 calendar days of completion of the originating study. If Day 1 for this study is greater than 7 days from the completion of the originating study, new Baseline assessments will be obtained. Participants will return to the clinical site 6 weeks after administration of the first inclacumab dose for safety assessments. They will then return every 12 weeks after the Day 1 dose administration for inclacumab administration, safety assessments, and collection of VOC events. Collection of QoL assessments and days missed from school/work will be collected at these visits. The study will continue with every 12-week visits for dosing if participants continue to receive clinical benefit that outweighs risk, as determined by the Investigator, until the participant has access to inclacumab from an alternative source (eg, through commercialization or a managed-access program)., 260, Experimental Group, Inclacumab, All participants will receive inclacumab 30 mg/kg administered intravenously., Every 12 weeks, Eligible participants will receive open-label inclacumab on Day 1. It is intended that Day 1 coincides with the final visit from the originating inclacumab study. End of Study assessments from the originating study will serve as Baseline assessments for this study. If Day 1 does not occur on the same day, the Day 1 Visit must occur within 30 calendar days of completion of the originating study. If Day 1 for this study is greater than 7 days from the completion of the originating study, new Baseline assessments will be obtained. Participants will return to the clinical site 6 weeks after administration of the first inclacumab dose for safety assessments. They will then return every 12 weeks after the Day 1 dose administration for inclacumab administration, safety assessments, and collection of VOC events. Collection of QoL assessments and days missed from school/work will be collected at these visits. The study will continue with every 12-week visits for dosing if participants continue to receive clinical benefit that outweighs risk, as determined by the Investigator, until the participant has access to inclacumab from an alternative source (eg, through commercialization or a managed-access program)., 520,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 15/06/2021 Data entry error Experimental Group, Inclacumab, All participants will receive inclacumab 30 mg/kg administered intravenously., Every 12 weeks, Eligible participants will receive open-label inclacumab on Day 1. It is intended that Day 1 coincides with the final visit from the originating inclacumab study. End of Study assessments from the originating study will serve as Baseline assessments for this study. If Day 1 does not occur on the same day, the Day 1 Visit must occur within 30 calendar days of completion of the originating study. If Day 1 for this study is greater than 7 days from the completion of the originating study, new Baseline assessments will be obtained. Participants will return to the clinical site 6 weeks after administration of the first inclacumab dose for safety assessments. They will then return every 12 weeks after the Day 1 dose administration for inclacumab administration, safety assessments, and collection of VOC events. Collection of QoL assessments and days missed from school/work will be collected at these visits. The study will continue with every 12-week visits for dosing if participants continue to receive clinical benefit that outweighs risk, as determined by the Investigator, until the participant has access to inclacumab from an alternative source (eg, through commercialization or a managed-access program)., 520, Experimental Group, Inclacumab, All participants will receive inclacumab 30 mg/kg administered intravenously., The study will continue until all participants are no longer participating in the study or until the Sponsor determines that the study should be discontinued due to safety or other reasons, Eligible participants will receive open-label inclacumab on Day 1. It is intended that Day 1 coincides with the final visit from the originating inclacumab study. End of Study assessments from the originating study will serve as Baseline assessments for this study. If Day 1 does not occur on the same day, the Day 1 Visit must occur within 30 calendar days of completion of the originating study. If Day 1 for this study is greater than 7 days from the completion of the originating study, new Baseline assessments will be obtained. Participants will return to the clinical site 6 weeks after administration of the first inclacumab dose for safety assessments. They will then return every 12 weeks after the Day 1 dose administration for inclacumab administration, safety assessments, and collection of VOC events. Collection of QoL assessments and days missed from school/work will be collected at these visits. The study will continue with every 12-week visits for dosing if participants continue to receive clinical benefit that outweighs risk, as determined by the Investigator, until the participant has access to inclacumab from an alternative source (eg, through commercialization or a managed-access program)., 520,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 15/06/2021 Data entry error Experimental Group, Inclacumab, All participants will receive inclacumab 30 mg/kg administered intravenously., The study will continue until all participants are no longer participating in the study or until the Sponsor determines that the study should be discontinued due to safety or other reasons, Eligible participants will receive open-label inclacumab on Day 1. It is intended that Day 1 coincides with the final visit from the originating inclacumab study. End of Study assessments from the originating study will serve as Baseline assessments for this study. If Day 1 does not occur on the same day, the Day 1 Visit must occur within 30 calendar days of completion of the originating study. If Day 1 for this study is greater than 7 days from the completion of the originating study, new Baseline assessments will be obtained. Participants will return to the clinical site 6 weeks after administration of the first inclacumab dose for safety assessments. They will then return every 12 weeks after the Day 1 dose administration for inclacumab administration, safety assessments, and collection of VOC events. Collection of QoL assessments and days missed from school/work will be collected at these visits. The study will continue with every 12-week visits for dosing if participants continue to receive clinical benefit that outweighs risk, as determined by the Investigator, until the participant has access to inclacumab from an alternative source (eg, through commercialization or a managed-access program)., 520, Experimental Group, Inclacumab, 30 mg/kg every 12 weeks (Q12W), The study will continue until all participants are no longer participating in the study or until the Sponsor determines that the study should be discontinued due to safety or other reasons, Eligible participants will receive open-label inclacumab on Day 1. It is intended that Day 1 coincides with the final visit from the originating inclacumab study. End of Study assessments from the originating study will serve as Baseline assessments for this study. If Day 1 does not occur on the same day, the Day 1 Visit must occur within 30 calendar days of completion of the originating study. If Day 1 for this study is greater than 7 days from the completion of the originating study, new Baseline assessments will be obtained. Participants will return to the clinical site 6 weeks after administration of the first inclacumab dose for safety assessments. They will then return every 12 weeks after the Day 1 dose administration for inclacumab administration, safety assessments, and collection of VOC events. Collection of QoL assessments and days missed from school/work will be collected at these visits. The study will continue with every 12-week visits for dosing if participants continue to receive clinical benefit that outweighs risk, as determined by the Investigator, until the participant has access to inclacumab from an alternative source (eg, through commercialization or a managed-access program)., 520,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 09/07/2021 Data entry update Experimental Group, Inclacumab, 30 mg/kg every 12 weeks (Q12W), The study will continue until all participants are no longer participating in the study or until the Sponsor determines that the study should be discontinued due to safety or other reasons, Eligible participants will receive open-label inclacumab on Day 1. It is intended that Day 1 coincides with the final visit from the originating inclacumab study. End of Study assessments from the originating study will serve as Baseline assessments for this study. If Day 1 does not occur on the same day, the Day 1 Visit must occur within 30 calendar days of completion of the originating study. If Day 1 for this study is greater than 7 days from the completion of the originating study, new Baseline assessments will be obtained. Participants will return to the clinical site 6 weeks after administration of the first inclacumab dose for safety assessments. They will then return every 12 weeks after the Day 1 dose administration for inclacumab administration, safety assessments, and collection of VOC events. Collection of QoL assessments and days missed from school/work will be collected at these visits. The study will continue with every 12-week visits for dosing if participants continue to receive clinical benefit that outweighs risk, as determined by the Investigator, until the participant has access to inclacumab from an alternative source (eg, through commercialization or a managed-access program)., 520, Experimental Group, Inclacumab, 30 mg/kg every 12 weeks (Q12W), The study will continue with every 12-week visits for dosing if participants continue to receive clinical benefit that outweighs risk, as determined by the Investigator, until the participant has access to inclacumab from an alternative source (eg, through commercialization or a managed-access program). , Eligible participants will receive open-label inclacumab on Day 1. It is intended that Day 1 coincides with the final visit from the originating inclacumab study. End of Study assessments from the originating study will serve as Baseline assessments for this study. If Day 1 does not occur on the same day, the Day 1 Visit must occur within 30 calendar days of completion of the originating study. If Day 1 for this study is greater than 7 days from the completion of the originating study, new Baseline assessments will be obtained. Participants will return to the clinical site 6 weeks after administration of the first inclacumab dose for safety assessments. They will then return every 12 weeks after the Day 1 dose administration for inclacumab administration, safety assessments, and collection of VOC events. Collection of QoL assessments and days missed from school/work will be collected at these visits. The study will continue with every 12-week visits for dosing if participants continue to receive clinical benefit that outweighs risk, as determined by the Investigator, until the participant has access to inclacumab from an alternative source (eg, through commercialization or a managed-access program)., 520,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 22/07/2021 Data entry update Experimental Group, Inclacumab, 30 mg/kg every 12 weeks (Q12W), The study will continue with every 12-week visits for dosing if participants continue to receive clinical benefit that outweighs risk, as determined by the Investigator, until the participant has access to inclacumab from an alternative source (eg, through commercialization or a managed-access program). , Eligible participants will receive open-label inclacumab on Day 1. It is intended that Day 1 coincides with the final visit from the originating inclacumab study. End of Study assessments from the originating study will serve as Baseline assessments for this study. If Day 1 does not occur on the same day, the Day 1 Visit must occur within 30 calendar days of completion of the originating study. If Day 1 for this study is greater than 7 days from the completion of the originating study, new Baseline assessments will be obtained. Participants will return to the clinical site 6 weeks after administration of the first inclacumab dose for safety assessments. They will then return every 12 weeks after the Day 1 dose administration for inclacumab administration, safety assessments, and collection of VOC events. Collection of QoL assessments and days missed from school/work will be collected at these visits. The study will continue with every 12-week visits for dosing if participants continue to receive clinical benefit that outweighs risk, as determined by the Investigator, until the participant has access to inclacumab from an alternative source (eg, through commercialization or a managed-access program)., 520, Experimental Group, Inclacumab, 30 mg/kg every 12 weeks (Q12W), The study will continue with every 12-week visits for dosing if participants continue to receive clinical benefit that outweighs risk, as determined by the Investigator, until the participant has access to inclacumab from an alternative source (eg, through commercialization or a managed-access program). , Eligible participants will receive open-label inclacumab for 12 weeks, 520,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 15/11/2024 Data entry update Experimental Group, Inclacumab, 30 mg/kg every 12 weeks (Q12W), The study will continue with every 12-week visits for dosing if participants continue to receive clinical benefit that outweighs risk, as determined by the Investigator, until the participant has access to inclacumab from an alternative source (eg, through commercialization or a managed-access program). , Eligible participants will receive open-label inclacumab for 12 weeks, 520, Experimental Group, Inclacumab, 30 mg/kg every 12 weeks (Q12W), The study will continue with every 12-week visits for dosing if participants continue to receive clinical benefit that outweighs risk, as determined by the Investigator, until the participant has access to inclacumab from an alternative source (eg, through commercialization or a managed-access program). , Eligible participants will receive open-label inclacumab for 12 weeks, 242,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 15/06/2021 Data entry error Control Group, Placebo, 30 mg/kg every 12 weeks (Q12W), The study will continue until all participants are no longer participating in the study or until the Sponsor determines that the study should be discontinued due to safety or other reasons, Eligible participants will receive open-label inclacumab or Placebo on Day 1. It is intended that Day 1 coincides with the final visit from the originating inclacumab study. End of Study assessments from the originating study will serve as Baseline assessments for this study. If Day 1 does not occur on the same day, the Day 1 Visit must occur within 30 calendar days of completion of the originating study. If Day 1 for this study is greater than 7 days from the completion of the originating study, new Baseline assessments will be obtained. Participants will return to the clinical site 6 weeks after administration of the first inclacumab dose for safety assessments. They will then return every 12 weeks after the Day 1 dose administration for inclacumab administration, safety assessments, and collection of VOC events. Collection of QoL assessments and days missed from school/work will be collected at these visits. The study will continue with every 12-week visits for dosing if participants continue to receive clinical benefit that outweighs risk, as determined by the Investigator, until the participant has access to inclacumab from an alternative source (eg, through commercialization or a managed-access program)., 260, Placebo Control Group, Inclacumab, 30 mg/kg every 12 weeks (Q12W), The study will continue until all participants are no longer participating in the study or until the Sponsor determines that the study should be discontinued due to safety or other reasons, This multicenter, global, open-label extension study is designed to assess the safety of long-term treatment with inclacumab in participants with SCD. The study will be conducted globally and will be available to eligible participants enrolled in a prior GBT-Sponsored inclacumab clinical study (originating study). Participants must have completed participation in their originating clinical study and must meet the entry criteria for this study to be eligible for enrollment. The study will be conducted at up to 150 global clinical sites, and up to approximately 520 participants will be enrolled. Eligible participants will receive inclacumab 30 mg/kg administered IV Q12W if they continue to receive clinical benefit that outweighs risk, as determined by the Investigator, until the participant has access to inclacumab from an alternative source (eg, through commercialization or a managed-access program). All participants will undergo safety and outcome assessments at Baseline (Day 1), Week 6, and every 12 weeks thereafter. Visits to the clinical site for infusion of study drug will occur at Baseline (Day 1) and every 12 weeks (Weeks 12, 24, 36, 48, etc.)., 520, Uncontrolled
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 09/07/2021 Data entry error Experimental Group, Inclacumab, 30 mg/kg every 12 weeks (Q12W), The study will continue until all participants are no longer participating in the study or until the Sponsor determines that the study should be discontinued due to safety or other reasons, Eligible participants will receive open-label inclacumab on Day 1. It is intended that Day 1 coincides with the final visit from the originating inclacumab study. End of Study assessments from the originating study will serve as Baseline assessments for this study. If Day 1 does not occur on the same day, the Day 1 Visit must occur within 30 calendar days of completion of the originating study. If Day 1 for this study is greater than 7 days from the completion of the originating study, new Baseline assessments will be obtained. Participants will return to the clinical site 6 weeks after administration of the first inclacumab dose for safety assessments. They will then return every 12 weeks after the Day 1 dose administration for inclacumab administration, safety assessments, and collection of VOC events. Collection of QoL assessments and days missed from school/work will be collected at these visits. The study will continue with every 12-week visits for dosing if participants continue to receive clinical benefit that outweighs risk, as determined by the Investigator, until the participant has access to inclacumab from an alternative source (eg, through commercialization or a managed-access program)., 520,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 29/07/2021 Update to system in order to close the intervention tab and submit the trial. System instruction: "There must be a minimum of one Experimental & one Control group" Control Group, Not Applicable, Zero, Not Applicable, Not applicable, 0, Historical
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 09/07/2021 Update of data. National Hospital Abuja, Central Business District, Abuja, , Nigeria
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 09/07/2021 Update to data American University of Beirut Medical Center, American University Of Beirut Medical Center, Beirut, 11-0236, Lebanon
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 09/07/2021 Update to data Hospital Henri Mondor, 51 Avenue Marechal De Lattre De Tassigny, Creteil, 94010, France
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 09/07/2021 Update to data Dana Farber Cancer Institute, 4500 Brookline Avenue, Mayer 446, Boston, 2215, United States of America
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 09/07/2021 Update to data St Jude Childrens Research Hospital, Dmid-ctm Not required for Low Risk, Dmidctm, 333, United States of America
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 09/07/2021 Update to data Cukurova University Medical Faculty Balcali Hospital, Balcali, Remzioguzarik, 1250, Turkey
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 09/07/2021 Update to data University of South Florida, 12901 Bruce B. Downs Blvd, Tampa, 33612, United States of America
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 09/07/2021 Update of data Zagazig University Hospitals, Faculty Of Medicine, Block E, 1st Floor, Room 331, Mangaung, 9300, South Africa
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 09/07/2021 Update to data Al Kasr Al Ainy Cairo University Hospital, Al Manial, Cairo Governorate, Elmanial, , Egypt
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 09/07/2021 Update to data University of Illinois at Chicago, 1740 West Talylor Street, Chicago, 60612, United States of America
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 09/07/2021 Update to data Ain Shams University Hospital, Address Unknown, City Unknown, , Egypt
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 09/07/2021 Update to data E O Ospedali Galliera, Mura Delle Cappuccine, 14, Genova, 16128, Italy
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 09/07/2021 Update to data Hospital Avicenne, 125 Rue de Stalingrad, Bobigny, 93009, France
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 09/07/2021 Update to data Jacobi Medical Center, 111 E 210th St, Bronx, 2, United States of America
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 09/07/2021 Update to data Childrens Hospital of Orange County, 455 S Main St, Orange, 928683835, United States of America
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 09/07/2021 Update to data DMC Detroit Receiving Hospital, 4201 Saint Antoine St, Detroit, 482012153, United States of America
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 09/07/2021 Update to data Arkansas Childrens Hospital, 1 Childrens Way, Little Rock, 722023500, United States of America
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 09/07/2021 Update to data Azienda Ospedale Universita Padova, Via Giustiniani 3, Padova, 35128, Italy
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 09/07/2021 Update to data University of Michigan, 3912 Taubman Center, 1500 East Medical Center Drive, Ann Arbour, 48109, United States of America
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 09/07/2021 Update to data Kenya Medical Research Institute, Kisumu-kakamega Road, Kisumu, Nyanza, , Kenya
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 15/11/2022 Recruitment centre update Kenya Medical Research Institute, Kisumu-kakamega Road, Kisumu, Nyanza, , Kenya Strathmore University Medical centre, PO Box 59857-00200, Nairobi, 00200, Kenya
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 09/07/2021 Update to data Universitatsklinikum Freiburg, Hugstetter Str. 55, Freiburg, 79106, Germany
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 09/07/2021 Update to data University Clinic Regensburg, Franz-Joseph-Strauss-Allee 11, Regensburg, 93053, Germany
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 09/07/2021 Update to data AOU dellUniversita degli Studi della Campania Luigi Vanvitelli, Via Luigi De Crecchio 4, Napoli, 80138, Italy
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 09/07/2021 Update to data Centre Hospitalier Intercommunal, 40 Avenue De Verdun, Creteil, 94010, France
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 09/07/2021 Update to data Aflac Cancer and Blood Disorders Center, 1001 Johnson Ferry Road, Atlanta, 303421605, United States of America
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 09/07/2021 Update to data Matero Clinical Research Site, Off Alick Nkhata Road, Lusaka, 10101, Zambia
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 09/07/2021 Update to data Sociedad de Oncologia y hematologia del Cesar Ltda, Carrera 15 14 91, Valledupar, 200001, Colombia
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 09/07/2021 Update to data CHU de Toulouse IUCT ONCOPOLE, 1 Avenue Irene Joliot Curie, Toulouse, 31100, France
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 09/07/2021 Update to data Nini Hospital, Achier El Daya , Tarablus, , Lebanon
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 09/07/2021 Update to data Organizacion Clinica Bonnadona Prevenir S.A.S, Carrera 49 C 82-70 Torre Administrativa Piso 2, Barranquilla, 180020, Colombia
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 09/07/2021 Update to data Kings College Hospital, Denmark Hill, London, SE5 9RS, United Kingdom
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 09/07/2021 Update to data Gertrudes Childrens Hospital, 34 Muthaiga Rd, Nairobi, , Kenya
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 15/11/2022 Recruitment centre update Gertrudes Childrens Hospital, 34 Muthaiga Rd, Nairobi, , Kenya Gertrudes Childrens Hospital, 34 Muthaiga Rd, Nairobi, 00100, Kenya
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 09/07/2021 Update to data Aminu Kano Teaching Hospital, 11399 P Close Zaria Road, Lagos, 3452, Nigeria
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 09/07/2021 Update to data University of Nigeria, Kwame Nkuruma Way, Enugu, , Nigeria
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 09/07/2021 Update to data Lagos University Teaching Hospital Haematology, PO Box 12003, Surulere, 101014, Nigeria
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 09/07/2021 Update to data University of Abuja Teaching Hospital, PMB 117 Gwagwalada FCT, Abuja, , Nigeria
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 09/07/2021 Update to data National Hospital Abuja, Central Business District, Abuja, , Nigeria
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 09/07/2021 Update to data University of Calabar Teaching Hospital, PMB 1278, Calabar, , Nigeria
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 09/07/2021 Update to data Sultan Qaboos University Hospital, 35 Alkoudh, Al Koudh, 123, Oman
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 09/07/2021 Update to data Sultan Qaboos University Hospital, 35 Alkoudh, Al Khoudh, 123, Oman
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 09/07/2021 Update to data International Cancer Institute, P.O Box 8088, Eldoret Gpo, 30100, Kenya
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 15/11/2022 Recruitment centre update International Cancer Institute, P.O Box 8088, Eldoret Gpo, 30100, Kenya International Cancer Institute, P.O Box 8088, Eldoret , 30100, Kenya
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 09/07/2021 Update to data NIMR Mbeya Medical Research Center, Hospital Hill Road, Mbeya, , United Republic of Tanzania
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 09/07/2021 Update to data Kwame Nkurumah University of Science, Office of Dean/Department of Child Health, Kumasi, , Ghana
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 15/11/2022 Status update Kwame Nkurumah University of Science, Office of Dean/Department of Child Health, Kumasi, , Ghana Komfo Anokye Teaching Hospital KATH, Office of Dean/Department of Child Health, Kumasi, , Ghana
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 09/07/2021 Update to data KEMRI CRDR Clinical Research Clinic Nairobi, Off Hospital Road, Nairobi, , Kenya
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 15/11/2022 Postal code update KEMRI CRDR Clinical Research Clinic Nairobi, Off Hospital Road, Nairobi, , Kenya KEMRI CRDR Clinical Research Clinic Nairobi, Off Hospital Road, Nairobi, 00100, Kenya
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 09/07/2021 Update to data Kasr El Aini Hospital, Address Unknown, City Unknown, , Egypt
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 09/07/2021 Update to data Clinica De La Costa PPDS, Carrera 50 Numero 80-90, Barranquilla, 80020, Colombia
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 15/11/2022 Recruitment centre update NIMR Mbeya Medical Research Center, Hospital Hill Road, Dar es Slam, 53107, Tanzania
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 16/11/2022 Recruitment centre update The University Teaching Hospital Childrens Hospital, RW 1X , Nationalist Road, Lusaka, 10101, Zambia
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 16/11/2022 Recruitment centre update Arthur Davison Childrens Hospital, Corner Chiwanangala and Boundary Roads, Northrise, Ndola, 10101, Zambia
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 17/06/2021 Data entry error FALSE, KEMRI SERU, Off Mbagathi Road, Nairobi, 00200, Kenya, 19 May 2021, , +254722205901, director@kemri.org, FALSE, KEMRI SERU, Off Mbagathi Road, Nairobi, 00200, Kenya, 15 Jun 2021, , +2540202722541, seru@kemri.org,
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 15/11/2022 Ethics approval update FALSE, KEMRI SERU, Off Mbagathi Road, Nairobi, 00200, Kenya, 15 Jun 2021, , +2540202722541, seru@kemri.org, TRUE, KEMRI SERU, Off Mbagathi Road, Nairobi, 00200, Kenya, 15 Jun 2021, 19 Sep 2022, +2540202722541, seru@kemri.org, 15876_13243_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 15/11/2022 Ethics approval update TRUE, KEMRI scientific and Ethics review Unit, P.O. Box 54840-00200, Nairobi , Nairobi, 00200, Kenya, , 19 Sep 2022, +2540202722541, ddrt@kemri.go.ke, 15876_19830_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 15/11/2022 Ethics approval update TRUE, KEMRI Scientific and Ethics Review Unit, P.O. Box 54840-00200, Nairobi, 00200, Kenya, , 02 Sep 2021, 2542722541, director@kemri.org, 15876_19831_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 15/11/2022 Ethics approval update TRUE, KEMRI scientific and Ethics Review unit, P.O. Box 54840-00200, Nairobi, Nairobi, 00200, Kenya, , 11 Feb 2022, +2542722541, director@kemri.org, 15876_19832_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 15/11/2022 Ethics approval update TRUE, Gertrudes Childrens Hospital , 34, Muthaiga Rd Nairobi, Nairobi, 00100, Kenya, , 21 Jun 2022, +254207206000, jgithanga3@gmail.com,
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 15/11/2022 Status update TRUE, Gertrudes Childrens Hospital , 34, Muthaiga Rd Nairobi, Nairobi, 00100, Kenya, , 21 Jun 2022, +254207206000, jgithanga3@gmail.com, TRUE, Gertrudes Childrens Hospital , 34, Muthaiga Rd Nairobi, Nairobi, 00100, Kenya, , 21 Jun 2022, +254207206000, jgithanga3@gmail.com, 15876_19833_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 15/11/2022 Ethics approval update TRUE, National Institute for Medical Research, P.O. Box 9653 11101 Dar es Salaam, 3 Barack Obama Drive , Dar es Salam, 11101, Tanzania, , 26 Oct 2021, +255222121400, nimrethics@gmail.com, 15876_19837_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 15/11/2022 Ethics approval update TRUE, Komfo Anokye Teaching Hospital Institutional Review Board, P.O.Box 1934 Kumasi, Ashanti, Ghana, Ashanti, 1934, Ghana, , 14 Mar 2022, +233320022301, kath@hsp.org, 15876_20840_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 16/11/2022 Ethics approval updated TRUE, University of Zambia Biomedical Research Ethics committee , Ridgeway campus PO Box 50110, Lusaka , 44370, Zambia, , 08 Oct 2021, +260977925304, unzarec@unza.zm, 15876_20849_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 16/11/2022 Ethics approval updated TRUE, ERES CONVERGE IRB, Olive Tree Mean Wood road , Lusaka, Lusaka, Zambia, , 27 Jan 2022, +260955155633, eresconverge@yahoo.co.uk, 15876_20850_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 16/11/2022 Ethics approval updated TRUE, ERES CONVERGE IRB, Olive Tree Mean Wood road, Lusaka, Lusaka, Zambia, , 11 Jan 2022, +260955155633, eresconverge@yahoo.co.uk, 15876_20851_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 14/06/2021 Data entry error Global Blood Therapeutics Inc, 181 Oyster Point Blvd, South San Francisco, 94080, United States of America, Self Funded,
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 09/04/2024 Source of fund updated to commercial sector/industry. had been noted as self funding . Global Blood Therapeutics Inc, 181 Oyster Point Blvd, South San Francisco, 94080, United States of America, Self Funded, Global Blood Therapeutics Inc, 181 Oyster Point Blvd, South San Francisco, 94080, United States of America, Commercial Sector / Industry,
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 15/11/2024 Source of fund updated to commercial sector/industry. had been noted as self funding . Global Blood Therapeutics Inc, 181 Oyster Point Blvd, South San Francisco, 94080, United States of America, Commercial Sector / Industry, Global Blood Therapeutics Inc. a wholly owned subsidiary of Pfizer Inc., 181 Oyster Point Blvd, South San Francisco, 94080, United States of America, Commercial Sector / Industry,
Section Name Field Name Date Reason Old Value Updated Value
Sponsors Sponsors List 17/04/2024 The GBT company has been acquired by Pfizer Global Blood Therapeutics Inc., 181 Oyster Point Blvd, South San Francisco, CA94080, United States of America, Primary Sponsor, Other, Pharma Company Global Blood Therapeutics Inc a wholly owned subsidiary of Pfizer Inc, 181 Oyster Point Blvd, South San Francisco, CA94080, United States of America, Primary Sponsor, Other, Pharma Company
Section Name Field Name Date Reason Old Value Updated Value
Sponsors Sponsors List 15/11/2024 The GBT company has been acquired by Pfizer Global Blood Therapeutics Inc a wholly owned subsidiary of Pfizer Inc, 181 Oyster Point Blvd, South San Francisco, CA94080, United States of America, Primary Sponsor, Other, Pharma Company A wholly owned subsidiary of Pfizer Inc, 181 Oyster Point Blvd, South San Francisco, CA94080, United States of America, Primary Sponsor, Other, Pharma Company
Section Name Field Name Date Reason Old Value Updated Value
Collaborators Collaborators List 15/11/2022 Collaborators details updates Bernhards Ogutu, Kisumu kakamega Road, Nyanza, , Kenya Bernhards Ogutu, Ole Sangale Road, Madaraka Estate, Nairobi, 00200, Kenya
Section Name Field Name Date Reason Old Value Updated Value
Collaborators Collaborators List 15/11/2022 Status update Jessie Githanga, 34 Muthaiga Rd, Nairobi, , Kenya Jessie Githanga, 34 Muthaiga Rd, Nairobi, 00100, Kenya
Section Name Field Name Date Reason Old Value Updated Value
Collaborators Collaborators List 15/11/2022 Status update Videlis Nduba, Siaya County Hospital, Siaya, 14440600, Kenya Videlis Nduba, Siaya County Hospital, Siaya, 144-40600, Kenya
Section Name Field Name Date Reason Old Value Updated Value
Collaborators Collaborators List 15/11/2022 Status update Videlis Nduba, Off hospital road, Nairobi, , Kenya Videlis Nduba, Off hospital road, Nairobi, 00100, Kenya
Section Name Field Name Date Reason Old Value Updated Value
Collaborators Collaborators List 16/11/2022 New update Dr. Chunda Liyoka, Nationalist Road, Lusaka, 10101, Zambia
Section Name Field Name Date Reason Old Value Updated Value
Collaborators Collaborators List 16/11/2022 Status update Dr. Mwansa Jonathan, Corner Chiwanangala and Boundary Roads, Northrise, Ndola, 10101, Zambia
Section Name Field Name Date Reason Old Value Updated Value
Collaborators Collaborators List 15/11/2024 New information Pakbaz Zahra, 101 the City Dr South, Orange, 92868-320, United States of America
Section Name Field Name Date Reason Old Value Updated Value
Collaborators Collaborators List 15/11/2024 New information Videlis Nduba, Kenyatta Hospital complex Off hospital Road, Nairobi, 0100, Kenya
Section Name Field Name Date Reason Old Value Updated Value
Collaborators Collaborators List 15/11/2024 New information Unal Sule , Hacettepe Gevher , Ankara, 6230, Turkey
Section Name Field Name Date Reason Old Value Updated Value
Collaborators Collaborators List 15/11/2024 New information Cancado Rodolfo, Rua Conselheiro Brotero, 1486, Sao Paulo, 01232-010, Oman
Section Name Field Name Date Reason Old Value Updated Value
Collaborators Collaborators List 15/11/2024 New information Cavalheiro Rita de Cassia, Rua Santa Marcelina, 177, Sao Paulo, 08270-070, Brazil
Section Name Field Name Date Reason Old Value Updated Value
Collaborators Collaborators List 15/11/2024 New information Marri Preethi, 1700 Center St, Mobile, 36604-330, United States of America
Section Name Field Name Date Reason Old Value Updated Value
Collaborators Collaborators List 15/11/2024 New information Moura Patricia, Rua Frei Caneca, 8, Rio De Janeiro, 20211-030, Brazil
Section Name Field Name Date Reason Old Value Updated Value
Collaborators Collaborators List 15/11/2024 New information Idowu Modupe, 6431 Fannin St, Houston, 77030-150, United States of America
Section Name Field Name Date Reason Old Value Updated Value
Collaborators Collaborators List 15/11/2024 New information Telen Marilyn, 2301 Erwin Rd, Durham, 27705-469, United States of America
Section Name Field Name Date Reason Old Value Updated Value
Collaborators Collaborators List 15/11/2024 New information Alvarenga Laine, Avenida Sao Rafael 2152 6 Andar, Salvador, 41253-196, Brazil
Section Name Field Name Date Reason Old Value Updated Value
Collaborators Collaborators List 18/11/2024 New information Friedrisch Joao Ricardo, Rua Ramiro Barcelos, 2350, Porto Alegre, 90035-003, Brazil
Section Name Field Name Date Reason Old Value Updated Value
Collaborators Collaborators List 18/11/2024 New information Bello Manga Halima, Lafiya Road, City Centre, Kaduna, 800212, Nigeria
Section Name Field Name Date Reason Old Value Updated Value
Collaborators Collaborators List 18/11/2024 New information Ozdogu Hakan, Kisla Saglik Yerleskesi Gulh, Adana, 1123, Turkey
Section Name Field Name Date Reason Old Value Updated Value
Collaborators Collaborators List 18/11/2024 New information Malhan Hafiz, 2034 King Abdul Aziz Rd, Jazan, 82943, Saudi Arabia
Section Name Field Name Date Reason Old Value Updated Value
Collaborators Collaborators List 18/11/2024 New information Andemariam Biree, 263 Farmington Ave, Farmington, 06030-000, United States of America
Section Name Field Name Date Reason Old Value Updated Value
Collaborators Collaborators List 18/11/2024 New information Silva Pinto Ana Cristina, Avenida Bandeirantes 3900, Ribeirao Preto, 14048-900, Brazil
Section Name Field Name Date Reason Old Value Updated Value
Collaborators Collaborators List 18/11/2024 New information Waziri Aliyu, Kaduna state, PMB 06, Zaria, 810107, Nigeria
Section Name Field Name Date Reason Old Value Updated Value
Collaborators Collaborators List 18/11/2024 New information Lorenzetti Alexandre, Avenida Brigadeiro Faria Lima, 5546, Sao Jose Do Rio Preto, 15090-000, Brazil
Section Name Field Name Date Reason Old Value Updated Value
Collaborators Collaborators List 18/11/2024 New information Inati, Adlette, Al Maarad Street, 1434, Lebanon
Section Name Field Name Date Reason Old Value Updated Value
Collaborators Collaborators List 18/11/2024 New information da Silva Araujo Aderson, Rua Senador Jose Henrique 231, Recife, 50070-460, Brazil
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 15/11/2022 Status update Principal Investigator, Videlis, Nduba, Prof., vnduba@gmail.com, , +254724522474, KEMRI CRDR Cinical Research Annex, Nairobi, , Kenya, Medical Doctor Principal Investigator, Videlis, Nduba, Prof., vnduba@gmail.com, , +254724522474, KEMRI CRDR Cinical Research Annex, Nairobi, 00100, Kenya, Medical Doctor
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 09/07/2021 Typo Public Enquiries, Kalyan, Obalampalli, Mr., kobalampalli@gbt.com, , +2579162840777, 181 Oyster Point Blvd, Sounth San Francisco, CA94080, United States of America, Global Blood Therapeutics Inc Public Enquiries, Kalyan, Obalampalli, Mr., kobalampalli@gbt.com, , +2579162840777, 181 Oyster Point Blvd, South San Francisco, CA94080, United States of America, Global Blood Therapeutics Inc
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 09/07/2021 Update to data Public Enquiries, Kalyan, Obalampalli, Mr., kobalampalli@gbt.com, , +2579162840777, 181 Oyster Point Blvd, South San Francisco, CA94080, United States of America, Global Blood Therapeutics Inc Public Enquiries, Margot, Hottmann, Mr., mhottmann@gbt.com, , +16508228728, 181 Oyster Point Blvd, South San Francisco, CA94080, United States of America, Sr Clinical Trial Manager
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 09/07/2021 data entry update Public Enquiries, Margot, Hottmann, Mr., mhottmann@gbt.com, , +16508228728, 181 Oyster Point Blvd, South San Francisco, CA94080, United States of America, Sr Clinical Trial Manager Public Enquiries, Margot, Hottmann, Mr., mhottmann@gbt.com, , +0016508228728, 181 Oyster Point Blvd, South San Francisco, CA94080, United States of America, Sr Clinical Trial Manager
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 16/07/2021 Updated telephone number. Scientific Enquiries, Carolyn, Hoppe, Dr., choppe@gbt.com, , +0016507417741, 181 Oyster Point Blvd, South San Francisco, CA94080, United States of America, Sr. Director Medical Affairs Scientific Enquiries, Carolyn, Hoppe, Dr., choppe@gbt.com, , +0016508228728, 181 Oyster Point Blvd, South San Francisco, CA94080, United States of America, Sr. Director Medical Affairs
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 15/11/2024 Updated telephone number. Scientific Enquiries, Carolyn, Hoppe, Dr., choppe@gbt.com, , +0016508228728, 181 Oyster Point Blvd, South San Francisco, CA94080, United States of America, Sr. Director Medical Affairs Scientific Enquiries, Carolyn, Hoppe, Dr., choppe@pfizer.com, , +0016508228728, 181 Oyster Point Blvd, South San Francisco, CA94080, United States of America, Sr. Director Medical Affairs
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 20/11/2024 Updated telephone number. Scientific Enquiries, Carolyn, Hoppe, Dr., choppe@pfizer.com, , +0016508228728, 181 Oyster Point Blvd, South San Francisco, CA94080, United States of America, Sr. Director Medical Affairs Scientific Enquiries, Carolyn, Hoppe, Dr., choppe@pfizer.com, choppe@pfizer.com, +0016508228728, 181 Oyster Point Blvd, South San Francisco, CA94080, United States of America, Sr. Director Medical Affairs
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Minimum age 17/06/2021 Data entry error 18 Year(s) 12 Year(s)
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Maximum age 17/06/2021 Data entry error 65 Year(s) 85 Year(s)