9HB02PED - Paediatric Subjects With Haemophilia B

• Research type

  Research Study

• Full title

  An Open-label, Multicenter Evaluation of Safety, Pharmacokinetics, and Efficacy of Recombinant Coagulation Factor IX Fc Fusion Protein, BIIB029, in the Prevention and Treatment of Bleeding Episodes in Pediatric Subjects With Hemophilia B

• IRAS ID

  98495

• Contact name

  Raina Liesner

• Sponsor organisation

  Biogen Idec Research Ltd

• Eudract number

  2011-003076-36

• Clinicaltrials.gov Identifier

  NCT01440946

• Research summary

  The aim of this study is to assess the safety and efficacy of study treatment Recombinant Human Coagulation Factor IX Fusion Protein (rFIXFc) in previously treated paediatric subjects less than12 years of age with haemophilia B. The length of time rFIXFc stays in patients?? blood and quality of life will also be assessed. This is a multinational study. At least 20 subjects are planned to complete the study (10 subjects less than 6 years of age and 10 subjects 6 to less than 12 years of age). This is an open label study, which means that each subject in the study and the study staff will know what dose of rFIXFc the subject is being treated with. Surgery is allowed during the study.

• REC name

  London - Westminster Research Ethics Committee

• REC reference

  12/LO/0370

• Date of REC Opinion

  29 May 2012

• REC opinion

  Further Information Favourable Opinion