9HB01EXT - Long-Term Safety and Efficacy of (rFIXFc) Haemophilia B
Research type
Research Study
Full title
An Open-Label, Multicenter Evaluation of the Long-Term Safety and Efficacy of Recombinant Human Coagulation Factor IX Fusion Protein (rFIXFc) in the Prevention and Treatment of Bleeding Episodes in Previously Treated Subjects With Hemophilia B
IRAS ID
89063
Contact name
K John Pasi
Sponsor organisation
Biogen Idec Research Ltd
Eudract number
2011-003075-11
Clinicaltrials.gov Identifier
Research summary
9HB01EXT is an extension study designed to assess the long-term safety and efficacy of rFIXFc in previously treated subjects with haemophilia B. Male subjects of all ages who have completed the preceding studies of rFIXFc (B-LONG, 998HB102; and 9HB02PED) may be eligible for enrollment in this study. This is a multinational study in approximately 120 subjects. There will be two treatment groups. This is an open label study so the patient and all study staff will know which treatment the patient is receiving: Prophylaxis regimen (to prevent bleeding). On-Demand regimen (to treat bleeding episodes as and when they arise). If a subject requires surgery during this study, either emergency or planned, he may be treated with the dose and regimen of rFIXFc deemed appropriate for the type of surgery. The study will last for approximately 4 years or until marketing approval is obtained in the participating countries. The study is being sponsored by Biogen Idec.
REC name
South Central - Hampshire A Research Ethics Committee
REC reference
11/SC/0446
Date of REC Opinion
5 Dec 2011
REC opinion
Further Information Favourable Opinion