BAX 326 pivotal

• Research type

  Research Study

• Full title

  BAX 326 (recombinant Factor IX): A Phase 1/3Prospective, Controlled, Multicenter Study Evaluating Pharmacokinetics, Efficacy, Safety, and Immunogenicity in Previously Treated Patients with Severe (FIX level < 1%) or Moderately Severe (FIX level = 2%) Hemophilia B

• IRAS ID

  45782

• Contact name

  Pratima Chowdary

• Sponsor organisation

  Baxter Innovations GmbH

• Eudract number

  2009-016720-31

• ISRCTN Number

  Not Submitted

• Research summary

  This study is a Phase 1/3, multicenter study in patients to evaluate the PK parameters, safety, immunogenicity, hemostatic efficacy, and changes in quality of life of BAX 326 in a total of 60 patients with severe or moderately severe hemophilia B. The study is divided into three parts: Part 1 is a randomized, study to compare the Pharmacokinetic parameters of BAX 326 with the commercially available similar product BeneFIX in 30 patients. Part 2 is an open label evaluation of the hemostatic efficacy, safety, and quality of life of BAX 326, over a period of 26 weeks or at least 50 exposure days to BAX 326, in a total of 60 patients. Patients who have completed Part1 will move directly into to Part 2, and an additional 30 patients will participate in Part 2 only. Patients will receive prophylactic treatment consisting of BAX 326 twice weekly. Bleeding episodes will also be treated with BAX 326. Part 3 is an open label evaluation of the pharmacokinetic parameters of BAX 326 after 26 weeks of treatment in Part 2 in the 30 subjects who participated in Part 1.

• REC name

  London - Hampstead Research Ethics Committee

• REC reference

  10/H0720/41

• Date of REC Opinion

  9 Jun 2010

• REC opinion

  Further Information Favourable Opinion