BAX 326 Continuation study

• Research type

  Research Study

• Full title

  BAX 326 (recombinant Factor IX): Evaluation of Safety, Immunogenicity, and Hemostatic Efficacy in Previously Treated Patients with Severe (FIX level less than 1%) or Moderately Severe (FIX level less than or equal to 2%) Hemophilia B – A Continuation Study.

• IRAS ID

  73806

• Contact name

  Pratima Chowdary

• Sponsor organisation

  Baxter Innovations GmbH

• Eudract number

  2010-022726-33

• ISRCTN Number

  n/a

• Research summary

  This study is a Phase 3, multicentre study in patients to evaluate the safety, immunogenicity and hemostatic efficacy in previously treated patients with severe or moderately severe Haemophilia B. 60 patients who have participated in the previously approved BAX-326 project highlighted in question 5-2 of this application will take part in this study. Health related quality of life parameters will be observed during the course of the study.The study duration per subject in the UK will be approximately 12 months until the subject has accumulated a total of at least 150 EDs to BAX 326 in both the BAX 326 pivotal (250901) and BAX 326 continuation (251001) study.Patients will receive the study drug (BAX 326) either twice weekly, or modified prophylaxis according to their needs or on demand use of study drug which will depend on each patients management of bleeding and their physician.

• REC name

  London - Hampstead Research Ethics Committee

• REC reference

  11/LO/0224

• Date of REC Opinion

  2 Sep 2011

• REC opinion

  Further Information Favourable Opinion