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.: PACTR202412611774752 Date of Registration: 10/12/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title A clinical trial to investigate efficacy and safety of oxfendazole compared with placebo in adults with trichuriasis, and /or mansonellosis, and/or onchocerciasis and/or loiasis
Official scientific title A phase IIa, multi-country, randomized, placebo-controlled, double-blinded, adaptive, basket trial to assess the efficacy and safety of oxfendazole in adults with trichuriasis, and /or mansonellosis, and/or onchocerciasis and/or loiasis
Brief summary describing the background and objectives of the trial Oxfendazole (Biopharmaceutics Classification System (BCS) class II drug, i.e. drug with low solubility and high permeability) offers a number of advantages that are desirable for a new anthelmintic agent: As with other well-known anthelmintic drugs belonging to the benzimidazole class, oxfendazole has shown potent activity against a broad range of nematodes; The pharmacokinetics, safety and broad spectrum of efficacy of oxfendazole are consistently demonstrated in intestinal helminth infections in animals, as well as tissue-dwelling larval cestode and trematode infections in diverse animal species. Oxfendazole is a registered drug for veterinary use; Published first-in-human safety and pharmacokinetic data have shown its safety in humans; at acceptable exposure Oxfendazole acts against adult worms, but not the microfilarial stage and is thus a promising drug candidate that could be used in Loa-co-endemic areas. Thus, oxfendazole represents a promising candidate to expand the limited portfolio of antiparasitic drugs available to treat helminth infections in humans. The primary objective is to identify a safe and efficient dose of oxfendazole for each of the four indications: participants infected with one or more of the following: Onchocerca volvulus, Loa loa, Mansonella perstans or Trichuris trichiura . The associated endpoint is parasite load at day 18 (egg count for trichuriasis) and/or month 12 (mf count for all other indications). To demonstrate the safety, tolerability, characteristics of oxfendazole in helminth infected individuals. The associated endpoint is frequency of adverse events (AEs), serious adverse events (SAEs) and discontinuations or temporary suspensions of IP up to day 18 and to the end of the trial. Estimands are to be developed in SAP. To demonstrate efficacy characteristics of different oxfendazole dose regimens in helminth infected individuals.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) OXF 01
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied trichuriasis, mansonellosis, onchocerciasis and loiasis
Purpose of the trial Treatment: Drugs
Anticipated trial start date 31/01/2025
Actual trial start date
Anticipated date of last follow up 01/02/2028
Actual Last follow-up date
Anticipated target sample size (number of participants) 760
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
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
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomization Numbered containers Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Oxfendazole 400 mg QD 1 day T. trichiura single dose, oxfendazole 400 mg only for T. trichiura 3 days Day 1: 4 x 100 mg tablet + 4 x placebo tablets once daily, single oral dose administration, fasted Day 2-3: 8 × placebo tablets, once daily, single oral dose administration, fasted 40
Experimental Group Oxfendazole 800 mg QD 1 day T. trichiura single dose, oxfendazole 800 mg only for T. trichiura 3 days Day 1: 8 x 100 mg tablet, once daily, single oral dose administration, fasted Day 2-3: 8x placebo, once daily, single oral dose administration, fasted 40
Control Group Placebo SD T. trichiura 3 days 8 × placebo tablets, once daily, single oral dose administration, fasted 40 Placebo
Experimental Group Oxfendazole 400 mg QD 5 day O. volvulus L. loa M perstans multiple doses, oxfendazole 400 mg for O. volvulus, L. loa, M. perstans 5 days 4 x 100 mg tablet + 4 x placebo tablets, once daily, multiple (5x) oral doses administration, fasted 120
Experimental Group Oxfendazole 800 mg QD 5 day O. volvulus L. loa M perstans multiple doses, oxfendazole 800 mg for O. volvulus, L. loa, M. perstans 5 days 8 x 100 mg tablet, once daily, multiple (5x) oral doses administration, fasted 120
Control Group Placebo MD 5 days 5 days 8 × placebo tablets, once daily, multiple oral doses administration, fasted 120 Placebo
Experimental Group Adaptive Arm Oxfendazole 400 mg MD 5 days multiple doses, oxfendazole 400 mg for O. volvulus, L. loa, M. perstans 5 days 4 x 100 mg tablet + 4 x placebo tablets, once daily, multiple (5x) oral doses administration, fasted 48
Experimental Group Adaptive Arm Oxfendazole 800 mg QD 5 days multiple doses, oxfendazole 800 mg for O. volvulus, L. loa, M. perstans 5 days 8 x 100 mg tablet, once daily, multiple (5x) oral doses administration, fasted 48
Experimental Group Adaptive Arm Oxfendazole 800 mg QD 2x 5 days multiple doses, oxfendazole 800 mg for O. volvulus, L. loa, M. perstans 2 x 5 days one month apart 8 x 100 mg tablet, once daily, multiple (2x 5 days one month apart) oral doses administration, fasted 48
Control Group Adaptive Arm Placebo QD 2x 5 days 2 x 5 days one month apart 8 × placebo tablets, once daily, multiple oral doses administration, fasted 48 Placebo
Experimental Group Oxfendazole 800 mg QD 3 days T. Trichuris multiple dose, oxfendazole 800 mg only for T. trichiura 3 days 8 × 100 mg Oxfendazol tablets, once daily, single oral dose administration, fasted 40
Control Group Adaptive Arm Placebo QD 5 days 5 days 8 x Placebo tablet, once daily, multiple (5x) oral doses administration, fasted 48 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Participant must be the legal age of consent in the jurisdiction in which the clinical trial is taking place to 65 years of age inclusive, at the time of signing the informed consent. A diagnosis of one or more of the following: trichuriasis, mansonellosis, onchocerciasis and loiasis confirmed within 3 months before randomization. Body weight at screening ≥ 45 kg. Willingness of women of child-bearing potential to use a culturally acceptable, highly effective method of contraception, which is effective before the first IP intake and for at least 33 days after the last IP intake. Willingness of male participants to use a male condom for vaginal intercourse with female partners of childbearing potential in each course of study treatment : from first day of IP administration to 33 days from the last IP . Male participants should also be advised of the benefit for a female partner to use a highly effective method of contraception as a condom may break or leak when having sexual intercourse with a woman of childbearing potential who is not currently pregnant. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form and in this protocol. Participant is deemed clinically suitable for a placebo-controlled study of the duration planned. O. volvulus infection: diagnosed by skin snip method: documented mf positivity on skin assessment on at least 2 out of 4 skin snips. Presence of at least 1 excisable subcutaneous nodule/ onchocercoma detected through palpation Loa loa: infection as evidenced by peripheral microfilaremia assessed between 10am-4pm between 100-8,000 mf/ml M. perstans: infection diagnosed by mf-positivity in blood ≥ 200 mf/ml blood (10 mf via finger prick/~50μl) Trichuris trichiura: Being able and willing to provide two stool samples at screening and at follow-up assessment. Having at least two out of four Kato-Katz slides positive for T. trichiura at screening. Any condition, in the investigator's opinion, that places the participant at undue risk (symptoms, physical signs, vital signs or biological/laboratory signs suggestive of past or present systemic disorders, including but not limited to, cardiovascular, pulmonary, cutaneous, immunodeficiency, hepatic, renal, hematologic, psychiatric disorders, drug / alcohol abuse and other abnormalities likely to interfere with the interpretation of results of the trial) or to significantly affect the study outcomes as judged by the investigator. Current or chronic history of liver disease. This includes any liver disease considered clinically significant by the investigator (see protocol). Pregnant and breastfeeding women Hb < 10mg/dl at baseline AST/SGOT; ALT/SGPT and/or bilirubin > 1.5xULN at baseline. eGFR (using the Modification of Diet in Renal Disease equation, (Beck, 2023)) < 60 mL/min at baseline. More than one epileptic seizure within the past 5 years Paragonimus sp. eggs or Taenia sp. proglottids/eggs detectable in stool Acute and/or febrile illness requiring therapy within 14 days prior to baseline Anthelmintic therapy: For STH: within previous 1month prior baseline: ivermectin, moxidectin, diethylcarbamazine, albendazole, mebendazole For all other diseases: within previous 6 months prior baseline: ivermectin, moxidectin, diethylcarbamazine, albendazole, mebendazole within previous 12 months: doxycycline (> 2 weeks course) prior baseline Use of concomitant medication that is contraindicated with benzimidazoles and/or known hypersensitivity to benzimidazoles or any other ingredient in the oxfendazole tablet formulation Current or planned use of another investigational drug at any point during study participation. Participation in any interventional study within 3 months prior to screening or during the study, or within 5 times the half-life of the drug in the previous clinical trial, whichever is longer (time calculated relative to final in previous trial) Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 65 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
No 09/10/2024 National Ethics Committee for Human Health Research NECHHR
Ethics Committee Address
Street address City Postal code Country
Bastos street Yaounde p.o 1937 Cameroon
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 29/11/2024 ZAREC ZAHRI Zanzibar Health Research Institute
Ethics Committee Address
Street address City Postal code Country
87 Binguni Road, P.O. Box 236 Binguni 72208 United Republic of 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
No 29/11/2024 Ethikkommission Nordwest und Zentralschweiz EKNZ
Ethics Committee Address
Street address City Postal code Country
Tellplatz 11 Basel 4053 Swaziland
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 29/11/2024 Comite d Ethique institutionnel CEI
Ethics Committee Address
Street address City Postal code Country
Hsopital Albert Schweitzer Lambarene BP.242 Gabon
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 29/11/2024 Ethikkommission der Rheinischen Friedrich Wilhelms Universitaet Bonn
Ethics Committee Address
Street address City Postal code Country
Venusberg-Campus 1 Bonn 53127 Germany
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 29/11/2024 Comite National d Ethique de La Sante CNES
Ethics Committee Address
Street address City Postal code Country
1er Niveau, Kasa Vubu Kinshasa local 5 Democratic Republic of the Congo
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Identify a safe and efficient dose of oxfendazole for each of the four indications: participants infected with one or more of the following: Onchocerca volvulus (onchocerciasis), Loa loa (loiasis), Mansonella perstans (mansonellosis) or Trichuris trichiura (trichuriasis). The associated endpoint is parasite load at day 18 (egg count for trichuriasis) and/or month 12 (mf count for all other indications). 12 months onchocerciasis, loiasis, mansonellosis and 18 days trichuriasis
Secondary Outcome To demonstrate the safety, tolerability, characteristics of oxfendazole in helminth infected individuals. The associated endpoint is frequency of adverse events (AEs), serious adverse events (SAEs) and discontinuations or temporary suspensions of IP up to day 18 (and day 45 for Arms 10, 11) and to the end of the trial Day 1 till end of trial
Secondary Outcome To demonstrate pharmacokinetics characteristics of oxfendazole in helminth infected individuals. The associated endpoint is PK parameters (AUC0-t, AUC0-∞, AUCtau, Cmax, Tmax, t1/2 and Racc) of oxfendazole. 12 months
Secondary Outcome Onchocerca volvulus infection  Absence of live female adult worms with normal embryogenesis (assessed by histological examination of nodules collected at month 12)  Relative reduction of skin mf at day 18, (and day 45 for arms 10, 11), month 3, 6, 9 and 12  Absence of skin mf at day 18, (and day 45 for arms 10, 11), month 3, 6, 9 and 12  Absence of signs and symptoms of onchocerciasis day 18 (and day 45 for Arms 10, 11), month 3, 6, 9 and 12 12 months
Secondary Outcome Loa loa infection  Relative reduction of L. loa blood mf at day 18, (and day 45 for arms 10, 11), month 3, 6, 9 and 12  Area under the curve of L. loa blood mf during follow-up period for each dose level  Absence of L. loa blood mf at day 18, (and day 45 for arms 10, 11), month 3, 6, 9 and 12  Absence of signs and symptoms due to eye worm migration and Calabar swelling day 18, (and day 45 for arms 10, 11), month 3, 6, 9 and 12 12 months
Secondary Outcome Mansonella perstans infection  Relative reduction of M. perstans blood mf at day 18, (and day 45 for arms 10, 11), month 3, 6, 9 and 12  Area under the curve of M. perstans blood mf during follow-up period for each dose level  Absence of M. perstans blood mf at day 18, (and day 45 for arms 10, 11), month 3, 6, 9 and 12  Absence of signs and symptoms of pruritus, urticaria and oedema at day 18 (and day 45 for arms 10, 11), month 3, 6, 9 and 12 12 months
Secondary Outcome Trichuris trichiura infection  Relative reduction of eggs (egg reduction rate) at day 18 (assessed by quadruplicate Kato-Katz)  Absence of eggs (cure rate) at day 18 (assessed by quadruplicate Kato-Katz)  Relative reduction of eggs (egg reduction rate) at day 18 (assessed by quadruplicate Kato-Katz) for additional soil-transmitted helminth (STH) infections (Ascaris lumbricoides and hookworm)  Absence of eggs (cure rate) at day 18 (assessed by quadruplicate Kato-Katz) for additional STH infections (Ascaris lumbricoides and hookworm) 18 days
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
District Hospital Manjo Market street Manjo Cameroon
Public Health Laboratory Ivo de Carneri P.O. Box 122, Wawi Chake Chake Pemba United Republic of Tanzania
Centre de Recherche Medicales de Lambarene CERMEL BP.242 Lambarene Gabon
Centre de sante de reference de Kimpese Manyaki Kimpese Democratic Republic of the Congo
FUNDING SOURCES
Name of source Street address City Postal code Country
Global Health EDCTP3 Joint Undertaking Avenue de la Toison dOr Gulden Vileslaan Brussels 1060 Belgium
State Secretariat for Education Research and Innovation Swiss confederation Einsteinstrasse 2 Bern 3005 Switzerland
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Buea Molyko to Buea town road Buea Cameroon University
Primary Sponsor Institut National de Recherche Biomedicale M8R2 4WX Kinshasa Democratic Republic of the Congo Independent public research institution
Primary Sponsor Centre de Recherche Medical de Lambarene 86FJ 39W Lambarene Gabon Independent medical research center
Primary Sponsor Schweizerisches Tropen und Public Health Institut Kreuzstrasse 2 Allschil Tanzania Independent, academically affiliated research and education institute
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Samuel Wanji swanji@yahoo.fr 237694727715 University street, molyko
City Postal code Country Position/Affiliation
Buea Cameroon Head of Department of Microbiology and Parasitology University of Buea
Role Name Email Phone Street address
Principal Investigator Jennifer Keiser jennifer.keiser@swisstph.ch 41612848218 Kreuzstrasse 2
City Postal code Country Position/Affiliation
Allschwil United Republic of Tanzania Professor
Role Name Email Phone Street address
Principal Investigator Rella Zoleko Manego manegorella@yahoo.fr 24177155748 BP.242
City Postal code Country Position/Affiliation
Lambarene Gabon CERMEL BNITM
Role Name Email Phone Street address
Principal Investigator Dieudonne Mumba Ngoyi mumbadieudonne@yahoo.fr 243818118511 Av. De la Democratie
City Postal code Country Position/Affiliation
Kinshasa Democratic Republic of the Congo Institut National de Recherche Biomedicale
Role Name Email Phone Street address
Public Enquiries Glory Amambo gloryngongeh@yahoo.com 237679900360 University street, molyko
City Postal code Country Position/Affiliation
Buea Cameroon Head of Department of Microbiology and Parasitology University of Buea
Role Name Email Phone Street address
Scientific Enquiries Samuel Wanji swanji@yahoo.fr 237694727715 University street, molyko
City Postal code Country Position/Affiliation
Buea Cameroon Head of Department of Microbiology and Parasitology University of Buea
Role Name Email Phone Street address
Public Enquiries Jennifer Keiser jennifer.keiser@swisstph.ch 41612848218 Kreuzstrasse 2
City Postal code Country Position/Affiliation
Allschwil United Republic of Tanzania Professor
Role Name Email Phone Street address
Scientific Enquiries Jennifer Keiser jennifer.keiser@swisstph.ch 41612848218 Kreuzstrasse 2
City Postal code Country Position/Affiliation
Allschwil United Republic of Tanzania Professor
Role Name Email Phone Street address
Public Enquiries Adegnika Ayola Akim ayola-akim.adegnika@uni-tuebingen.de 070712983449 BP.242
City Postal code Country Position/Affiliation
Lambarene Gabon Direktor CERMEL and Research group leader
Role Name Email Phone Street address
Scientific Enquiries Rella Zoleko Manego manegorella@yahoo.fr 24177155748 BP.242
City Postal code Country Position/Affiliation
Lambarene Gabon CERMEL BNITM
Role Name Email Phone Street address
Public Enquiries Dieudonne Mumba Ngoyi mumbadieudonne@yahoo.fr 243818118511 Av. De la Democratie
City Postal code Country Position/Affiliation
Kinshasa Democratic Republic of the Congo Institut National de Recherche Biomedicale
Role Name Email Phone Street address
Scientific Enquiries Dieudonne Mumba Ngoyi mumbadieudonne@yahoo.fr 243818118511 Av. De la Democratie
City Postal code Country Position/Affiliation
Kinshasa Democratic Republic of the Congo Institut National de Recherche Biomedicale
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The data that support the findings of this study will not be shared publicly due to patient privacy concerns, lack of consent for data sharing and collaborative agreements between the consortium members. Researchers or institutions interested in related data may contact the corresponding author to discuss potential collaborations or aggregated data access, subject to institutional review board approval and compliance with applicable privacy regulations. The study protocol will be shared once it was finilized. Study Protocol Not applicable Not applicable
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 Trial description 21/11/2024 We added primary and secondary objectives as requested Oxfendazole (Biopharmaceutics Classification System (BCS) class II drug, i.e. drug with low solubility and high permeability) offers a number of advantages that are desirable for a new anthelmintic agent: • As with other well-known anthelmintic drugs belonging to the benzimidazole class, oxfendazole has shown potent activity against a broad range of nematodes; • The pharmacokinetics, safety and broad spectrum of efficacy of oxfendazole are consistently demonstrated in intestinal helminth infections in animals, as well as tissue-dwelling larval cestode and trematode infections in diverse animal species. Oxfendazole is a registered drug for veterinary use; • Published first-in-human safety and pharmacokinetic data have shown its safety in humans; at acceptable exposure • Oxfendazole acts against adult worms, but not the microfilarial stage and is thus a promising drug candidate that could be used in Loa-co-endemic areas. Thus, oxfendazole represents a promising candidate to expand the limited portfolio of antiparasitic drugs available to treat helminth infections in humans. Oxfendazole (Biopharmaceutics Classification System (BCS) class II drug, i.e. drug with low solubility and high permeability) offers a number of advantages that are desirable for a new anthelmintic agent: As with other well-known anthelmintic drugs belonging to the benzimidazole class, oxfendazole has shown potent activity against a broad range of nematodes; The pharmacokinetics, safety and broad spectrum of efficacy of oxfendazole are consistently demonstrated in intestinal helminth infections in animals, as well as tissue-dwelling larval cestode and trematode infections in diverse animal species. Oxfendazole is a registered drug for veterinary use; Published first-in-human safety and pharmacokinetic data have shown its safety in humans; at acceptable exposure Oxfendazole acts against adult worms, but not the microfilarial stage and is thus a promising drug candidate that could be used in Loa-co-endemic areas. Thus, oxfendazole represents a promising candidate to expand the limited portfolio of antiparasitic drugs available to treat helminth infections in humans. The primary objective is to identify a safe and efficient dose of oxfendazole for each of the four indications: participants infected with one or more of the following: Onchocerca volvulus, Loa loa, Mansonella perstans or Trichuris trichiura . The associated endpoint is parasite load at day 18 (egg count for trichuriasis) and/or month 12 (mf count for all other indications). To demonstrate the safety, tolerability, characteristics of oxfendazole in helminth infected individuals. The associated endpoint is frequency of adverse events (AEs), serious adverse events (SAEs) and discontinuations or temporary suspensions of IP up to day 18 and to the end of the trial. Estimands are to be developed in SAP. To demonstrate efficacy characteristics of different oxfendazole dose regimens in helminth infected individuals.
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 21/11/2024 We originally added the group size for each disease (40 for each disease) and will now revise it to total number across all three diseases =120 Experimental Group, Oxfendazole 400 mg QD 5 day O. volvulus L. loa M perstans, multiple doses, oxfendazole 400 mg for O. volvulus, L. loa, M. perstans, 5 days, 4 x 100 mg tablet + 4 x placebo tablets, once daily, multiple (5x) oral doses administration, fasted , 120,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 21/11/2024 Changes were made to the wrong arm Control Group, Adaptive Arm Placebo QD 5 days, , 5 days, 8 x Placebo tablet, once daily, multiple (5x) oral doses administration, fasted , 40, Placebo
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 21/11/2024 We originally added the group size for each disease (40 for each disease) and will now revise it to total number across all three diseases =120 Experimental Group, Oxfendazole 800 mg QD 5 day O. volvulus L. loa M perstans, multiple doses, oxfendazole 800 mg for O. volvulus, L. loa, M. perstans, 5 days, 8 x 100 mg tablet, once daily, multiple (5x) oral doses administration, fasted , 40, Experimental Group, Oxfendazole 800 mg QD 5 day O. volvulus L. loa M perstans, multiple doses, oxfendazole 800 mg for O. volvulus, L. loa, M. perstans, 5 days, 8 x 100 mg tablet, once daily, multiple (5x) oral doses administration, fasted , 120,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 21/11/2024 We originally added the group size for each disease (40 for each disease) and will now revise it to total number across all three diseases =120 Control Group, Placebo MD 5 days, , 5 days , 8 × placebo tablets, once daily, multiple oral doses administration, fasted , 40, Placebo Control Group, Placebo MD 5 days, , 5 days , 8 × placebo tablets, once daily, multiple oral doses administration, fasted , 120, Placebo
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 21/11/2024 In the second stage, a total of 240 (80 per disease) participants will be allocated (1:1 (if only arm 10 is selected) or 1:1:1 to the adaptive arm Experimental Group, Adaptive Arm Oxfendazole 400 mg MD 5 days, multiple doses, oxfendazole 400 mg for O. volvulus, L. loa, M. perstans, 5 days, 4 x 100 mg tablet + 4 x placebo tablets, once daily, multiple (5x) oral doses administration, fasted , 40, Experimental Group, Adaptive Arm Oxfendazole 400 mg MD 5 days, multiple doses, oxfendazole 400 mg for O. volvulus, L. loa, M. perstans, 5 days, 4 x 100 mg tablet + 4 x placebo tablets, once daily, multiple (5x) oral doses administration, fasted , 48,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 21/11/2024 In the second stage, a total of 240 (80 per disease) participants will be allocated (1:1 (if only arm 10 is selected) or 1:1:1 to the adaptive arm Experimental Group, Adaptive Arm Oxfendazole 800 mg QD 5 days, multiple doses, oxfendazole 800 mg for O. volvulus, L. loa, M. perstans, 5 days, 8 x 100 mg tablet, once daily, multiple (5x) oral doses administration, fasted , 40, Experimental Group, Adaptive Arm Oxfendazole 800 mg QD 5 days, multiple doses, oxfendazole 800 mg for O. volvulus, L. loa, M. perstans, 5 days, 8 x 100 mg tablet, once daily, multiple (5x) oral doses administration, fasted , 48,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 21/11/2024 In the second stage, a total of 240 (80 per disease) participants will be allocated (1:1 (if only arm 10 is selected) or 1:1:1 to the adaptive arm Experimental Group, Adaptive Arm Oxfendazole 800 mg QD 2x 5 days, multiple doses, oxfendazole 800 mg for O. volvulus, L. loa, M. perstans, 2 x 5 days one month apart, 8 x 100 mg tablet, once daily, multiple (2x 5 days one month apart) oral doses administration, fasted , 40, Experimental Group, Adaptive Arm Oxfendazole 800 mg QD 2x 5 days, multiple doses, oxfendazole 800 mg for O. volvulus, L. loa, M. perstans, 2 x 5 days one month apart, 8 x 100 mg tablet, once daily, multiple (2x 5 days one month apart) oral doses administration, fasted , 48,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 21/11/2024 In the second stage, a total of 240 (80 per disease) participants will be allocated (1:1 (if only arm 10 is selected) or 1:1:1 to the adaptive arm Control Group, Adaptive Arm Placebo QD 2x 5 days, , 2 x 5 days one month apart, 8 × placebo tablets, once daily, multiple oral doses administration, fasted , 40, Placebo Control Group, Adaptive Arm Placebo QD 2x 5 days, , 2 x 5 days one month apart, 8 × placebo tablets, once daily, multiple oral doses administration, fasted , 48, Placebo
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 21/11/2024 We originally added the group size for each disease (40 for each disease) and will now revise it to total number across all three diseases =120 Control Group, Adaptive Arm Placebo QD 5 days, , 5 days, 8 x Placebo tablet, once daily, multiple (5x) oral doses administration, fasted , 40, Placebo Control Group, Adaptive Arm Placebo QD 5 days, , 5 days, 8 x Placebo tablet, once daily, multiple (5x) oral doses administration, fasted , 120, Placebo
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 21/11/2024 In the second stage, a total of 240 (80 per disease) participants will be allocated (1:1 (if only arm 10 is selected) or 1:1:1 to the adaptive arm Control Group, Adaptive Arm Placebo QD 5 days, , 5 days, 8 x Placebo tablet, once daily, multiple (5x) oral doses administration, fasted , 40, Placebo Control Group, Adaptive Arm Placebo QD 5 days, , 5 days, 8 x Placebo tablet, once daily, multiple (5x) oral doses administration, fasted , 48, Placebo
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 25/11/2024 Additional information was provided. Summary results will be shared once Clinical Study Report will be available IPD will not be made available.
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 03/12/2024 We reviewed the IPD sharing section and rephrased it in accordance to the proposed layout. IPD will not be made available. The data that support the findings of this study will not be shared publicly due to patient privacy concerns, lack of consent for data sharing and collaborative agreements between the consortium members. Researchers or institutions interested in related data may contact the corresponding author to discuss potential collaborations or aggregated data access, subject to institutional review board approval and compliance with applicable privacy regulations. The study protocol will be shared once it was finilized.
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD-Sharing time frame 25/11/2024 Additional information was provided. Within 12 months of Clinical Study report finalization Not applicable
Section Name Field Name Date Reason Old Value Updated Value
Reporting Key access criteria 25/11/2024 Additional information was provided. Open access Not applicable