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.: PACTR201402000508243 Date of Approval: 22/02/2013
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title TADO
Official scientific title A Phase 3 double blind, randomized efficacy and safety comparison of prasugrel and placebo in pediatric patients with sickle cell disease.
Brief summary describing the background and objectives of the trial Sickle cell disease (SCD) is a genetic disorder in which vaso-occlusive crisis (VOC)is the principal complication.There is evidence linking platelets to sickle-cell pathology, specifically VOC.As a result, there is promise that prasugrel, an inhibitor of platelet activation and aggregation, may be beneficial in the prevention of VOC in pediatric patients with SCD.Primary objective: efficacy of prasugrel compared to placebo in pediatric patients with SCD measured by reduction in the rate of VOC
Type of trial RCT
Acronym (If the trial has an acronym then please provide) TADO
Disease(s) or condition(s) being studied Circulatory System,Paediatrics,Sickle Cell Disease
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 19/02/2013
Actual trial start date 01/03/2014
Anticipated date of last follow up 09/02/2015
Actual Last follow-up date
Anticipated target sample size (number of participants) 220
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
H7T-MC-TADO
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Dynamic allocation method of Pocock and Simon (1975) Central randomisation by phone/fax Masking/blinding used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Dynamic allocation method of Pocock and Simon (1975) Central randomisation by phone/fax 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 Prasugrel 0.8mg/kg/day, dose can be adjusted depending on the VN results 9-24 Months with optional open label extension of another 12 months Treatment for Sickle Cell Disease 110
Control Group Placebo 9-24 Months with option of extention of another 12 months Placebo 110 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
(1) Are patients with SCD (laboratory determined HbSS or HbS beta zero thalassemia) who have had ¿2 episodes of VOC in the past year [2] Have a body weight ¿19 kg and are ¿2 and <18 years of age, inclusive at the time of screening for the double-blind treatment period [3] If patients are ¿2 and ¿16 years of age, must have had a transcranial Doppler within the last year [4] Use of hydroxyurea is permitted under this protocol if the patient has been on a stable dose for the 60 days prior to randomization without signs of hematologic toxicity within 60 days of screening (see Section 9.8). [5] Have a legal representative that is in competent mental condition to provide written informed consent on behalf of the study participant before entering the study. The child may be required to give documented assent, if required by local regulations. [6] If sexually active, patients agree to use a reliable method of birth control during the study until 1 month following the last dose of study drug. Females of child-bearing potential must test negative for pregnancy at the time of enrollment based on a serum pregnancy test. (7)Vaso-occlusive crisis (requiring medical intervention) within 15 days prior to screening [8] Have a concomitant medical illness (for example, terminal malignancy) that in the opinion of the investigator is associated with reduced survival. [9] Hepatic dysfunction characterized by alanine aminotransferase (ALT) ¿3 x upper limit of normal (ULN) [10] Renal dysfunction requiring chronic dialysis or creatinine ¿1.2 mg/dL [11] Contraindication for antiplatelet therapy [12] History of intolerance or allergy to approved thienopyridines [13] Patients with a hematocrit <18%[14] History of abnormal or conditional transcranial Doppler (velocity in middle or anterior cerebral, or internal carotid artery ¿170 cm/sec) within the last year, regardless of age Bleeding Risk Criteria [15] History of bleeding diathesis [16] History of papillary necrosis [17] Active internal bleeding [18] History of spontaneous gastrointestinal bleeding [19] Gross hematuria or >300 RBC/high-powered field (HPF) on urinalysis at the time of screening [20] History of vitreous hemorrhage or proliferative retinopathy [21] Any of the following: ¿ History of TIA/ ischemic or hemorrhagic stroke ¿ Intracranial neoplasm, arteriovenous malformation, or aneurysm ¿ History of severe head trauma ¿ History of intracranial hemorrhage [22] Have clinical findings, in the judgment of the investigator, associated with an increased risk of bleeding [23] Platelet count <100,000 per ¿L of blood [24] Have had recent surgery (within 30 days prior to screening) or are scheduled to undergo surgery within the next 60 days [25] History of dysfunctional uterine bleeding 2 Year(s) 18 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 06/04/2013 KEMRI Ethical Review Committee
Ethics Committee Address
Street address City Postal code Country
Mbagathi Rd. Nairobi, Kenya Nairobi 0000 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
No 30/04/2013 COMMITTEE ON HUMAN RESEARCH PUBLICATION AND ETHICS
Ethics Committee Address
Street address City Postal code Country
School of Medical Sciences, Kwame Nkrumah University of Science and Technology & Komfo Anokye Teaching Hospital Kumasi 0000 Ghana
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome To assess the efficacy of prasugrel compared to placebo in in pediatric patients with SCD Continous
Secondary Outcome Long-term safety safety of prasugrel in pediatric patients with SCD Continous
Secondary Outcome Long term efficacy of prasugrel in pediatric patients with SCD continous
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Malaria research center, Agogo Agogo-Asante Akim, North district Agogo 0000 Ghana
Ridge Hospital, Childrens Department Korle-Bu Accra 0000 Ghana
Walter Reed - Kemri Kombewa 0000 Kenya
Kemri Kisumu Kisumu City 0000 Kenya
KEMRI/CDC Kisumu-Busia Road Kisumu 0000 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
Eli Lilly and Company Kentucky Ave Indianapolis 0000 United States of America
Eli Lilly and Company Kentucky street Indianapolis IN 46285 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Eli Lilly and Company Kentucky street Indianapolis IN 46285 United States of America Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
Dr Janet Nyawira Oyieko Kombewa Clinical Research Centre. Walter Reed Project, Off Kisumu-Bondo Road,Opposite Kombewa District Hospital Kombewa P. O. Box54 ¿ 40100 Kenya
Dr Jessie Nyokabi Githanga Gertrude's Children's Hospital Muthaiga Road, Off Thika Superhighway Nairobi P. O Box 42325 - 00 Kenya
Dr Videlis Nduba Kenya Medical Research Institute/ Centres for Disease Control and Prevention (KEMRI/CDC) KEMRI/CDC Research Collaboration Campus, Off Busia Road Kisian P.O Box 40100 Kenya
Dr Catherine Idara Segbefia Korle Bu Teaching Hospital (KBTH), Department of Child Health (DCH). Korle-BU Teaching Hospital Accra P.O Box KB77 Ghana
Bianca Palk 1011 Pretorius Ave South, Lyttelton Manor Centurion 0157 South Africa
Elbe Wessels Montrose Place, 2 Belle Rosa Street, Rosenpark, Bellville 7530 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Bernhards Ragama Ogutu Bernhards.ogutu@usamru-k.org + 254733966065 Kondele Children¿s Hospital, Within Jaramogi Oginga Odinga Teaching and Referral Hospital, Along Kisumu-Kakamega Road
City Postal code Country Position/Affiliation
Kisuma P. O. Box 54- 40100 Kenya Principle investigator
Role Name Email Phone Street address
Principal Investigator Tsiri Agbenyega tsiri@ghana.com +233208113848 Malaria Research Centre, Malaria Research Centre Office Building, Agogo Presbyterian Hospital
City Postal code Country Position/Affiliation
Asante- Akyem Ghana Principle investigator
Role Name Email Phone Street address
Principal Investigator Chunmei Zhou zhou_chunmei@lilly.com 317/655-9329 Eli Lilly & Company
City Postal code Country Position/Affiliation
Indianapolis 00 United States of America Statistician
Role Name Email Phone Street address
Principal Investigator Robert (Bob) H Seevers seevers_robert_h@lilly.com 317-651-4193 Eli Lilly & Company
City Postal code Country Position/Affiliation
Indianapolis United States of America Principle Research Scientist
Role Name Email Phone Street address
Public Enquiries Elbe Wessels elbe.wessels@quintiles.com +27 21 917 5800 2 Bella Rosa Street, Belville
City Postal code Country Position/Affiliation
Cape Town 7550 South Africa Clinical Project Manager
Role Name Email Phone Street address
Scientific Enquiries Chunmei Zhou zhou_chunmei@lilly.com 55
City Postal code Country Position/Affiliation
REPORTING
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
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