Research Trial to Study inhibitor development in previously untreated or minimally exposed Children to two different commercially available types of Factor VIII. This is Phase IV open lable , randomized,Study comparing Plasma derived Factor VIII with Recombinant Factor VIII.
- Conditions
- Health Condition 1: null- Severe Hemophilia A
- Registration Number
- CTRI/2009/091/001059
- Lead Sponsor
- Sintesi Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 300
1. Male subjects
2. Any ethnicity
3. Age 6 years
4. Severe haemophilia A (FVIII:C 1%), as confirmed by the central laboratory
5. A Patient with FVIII levels 1% and 2% will be separately recorded in the screening list
6. Previously untreated (0 EDs to any FVIII concentrate or blood products) or minimally treated (5 EDs) with blood components, namely whole blood, fresh frozen plasma, packed red blood cells, platelets or cryoprecipitate
7. A Patient not meeting these criteria will be separately recorded in the screening list.
8. Negative inhibitor measurement at both local and central laboratory at screening
9. Ability to comply with study requirements
10. Signed informed consent of legal tutors
1. Plasma FVIII level >=1%, as assayed at the central laboratory those patients originally diagnosed locally as severe but subsequently found to have FVIII levels ranging from 1% to 2% on testing at the central laboratory will be separately recorded in the screening list.
2. Previous history of FVIII inhibitor
3. Other congenital or acquired bleeding defects
4. Concomitant congenital or acquired immunodeficiencies
5. Concomitant treatment with systemic immunosuppressive drugs
6. Concomitant treatment with any investigational drug
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method