8HA01EXT Long-Term Safety and Efficacy of rFVIIIFc Haemophilia A

• Research type

  Research Study

• Full title

  An Open-Label, Multicenter Evaluation of the Long-Term Safety and Efficacy of Recombinant Human Coagulation Factor VIII Fusion Protein (rFVIIIFc) in the Prevention and Treatment of Bleeding Episodes in Previously Treated Subjects With Hemophilia A

• IRAS ID

  89988

• Contact name

  K John Pasi

• Sponsor organisation

  Biogen Idec Limited

• Eudract number

  2011-003072-37

• Clinicaltrials.gov Identifier

  NCT01454739

• Research summary

  8HA01EXT is an extension study designed to evaluate the long-term safety of rFVIIIFc for prevention and on-demand treatment of bleeding episodes in subjects with haemophilia A. Male subjects of all ages who have completed the preceding studies of rFVIIIFc (A-LONG, 997HA301 and 8HA02PED), or any other Phase 3 rFVIIIFc study may be eligible for enrolment in this study. This is a multinational study in approximately 194 subjects. There will be three treatment groups: On-Demand: all subjects enrolled in the trial and treated using an on-demand regimen. Prophylaxis: all subjects enrolled in the trial and treated using a prophylaxis or weekly (modified prophylaxis) regimen. Surgery subgroup: a subset of subjects from the prophylaxis and on-demand groups who have surgery during the course of the trial. Subjects will participate in this study for up to 4 years. The study is being sponsored by Biogen Idec.

• REC name

  London - Fulham Research Ethics Committee

• REC reference

  11/LO/1908

• Date of REC Opinion

  9 Jan 2012

• REC opinion

  Favourable Opinion