Bleeding in Previously Treated Subjects With Severe Haemophilia A
Research type
Research Study
Full title
A-LONG: An Open-label, Multicenter Evaluation of the Safety, Pharmacokinetics, and Efficacy of Recombinant Factor VIII Fc Fusion Protein (rFVIIIFc) in the Prevention and Treatment of Bleeding in Previously Treated Subjects With Severe Hemophilia A
IRAS ID
59995
Sponsor organisation
Biogen Idec Hemophilia Inc
Eudract number
2010 - 020558 - 33
Clinicaltrials.gov Identifier
Research summary
The study is being sponsored by Biogen Idec Hemophilia Inc.This is a multinational, multicentre study in 144 patients to look at the safety and effectiveness of the study drug rFVIIIFc as a possible FVIII replacement in patients with severe haemophilia A. The study will also look at how long the study drug stays in the patients' blood. Subjects will be male, aged at least 12 years and will have previously been treated with a FVIII replacement. Patients will be enrolled into one of 3 groups. Patients who have previously been taking a FVIII replacement on a regular basis to prevent bleeding (prophylaxis)will be placed in Group 1. Patients who have been taking a FVIII replacement to treat bleeding episodes as and when they arrise (on demand) may also decide to join Group 1 or will be placed in Groups 2 or 3 with an equal chance of being placed in either group.The study drug will be given as an injection. Group 1 will receive rFVIIIFC twice a week, Group 2 patients once a week and Group 3 patients will receive rFVIIIFC only when bleeding episodes occur. Patients will visit the clinic on a regular basis up to 52 weeks and a fortnightly telephone call will be made to the patient. Patients may also join two study sub-groups. One sub-group where additional blood testing will be done and the patients will be given a dose of Advate (a FVIII replacement already approved to treat haemophilia A) to see how long Advate will stay in the patient's blood compared to rFVIIIFc. The second sub-group will be for patients requiring surgery to find out how well rFVIIIFc works to control bleeding when given before, during, and after surgery.
REC name
London - Fulham Research Ethics Committee
REC reference
11/LO/0249
Date of REC Opinion
1 Jun 2011
REC opinion
Further Information Favourable Opinion