Phase 2/3 BAX326 Study in Paediatric Patients with Hemophilia B

• Research type

  Research Study

• Full title

  BAX326 (RECOMBINANT FACTOR IX): A PHASE 2/3 PROSPECTIVE, UNCONTROLLED, MULTICENTER STUDY EVALUATING PHARMACOKINETICS, EFFICACY, SAFETY, AND IMMUNOGENICITY IN PREVIOUSLY TREATED PEDIATRIC PATIENTS WITH SEVERE (FIX LEVEL < 1%) OR MODERATELY SEVERE (FIX LEVEL = 2%) HEMOPHILIA B

• IRAS ID

  90029

• Contact name

  Andrew Will

• Sponsor organisation

  Baxter Innovations GmbH

• Eudract number

  2011-002437-19

• Research summary

  BAX 326 is a recombinant human factor ix (rFix) product that's being developed by Baxter Corporation. It is intended for use as both on demand and prophylactic treatment of hemophilia B patients as well as for surgical prophylaxis. The main objective of this phase 2/3 trial is to evaluate the safety and hemostatic efficacy of BAX326 in the management and prevention of acute bleeding episodes for a period of 6 months.This trial would consist of two cohorts of 12 subjects each, based on the age of the subjects:<6 years and 6 years to 12 years. Within each cohort, subjects will be randomised to one of two blood sampling sequences for pharmacokinetic assesment, this is intended to enable the reduction of frequent blood sampling on the individual subject.There would be a total of 24 subjects in the study, with trial sites in Bulgaria, Russia, Germany, India , Romania, Ukraine and the United Kingdom.

• REC name

  North West - Liverpool Central Research Ethics Committee

• REC reference

  11/NW/0697

• Date of REC Opinion

  26 Oct 2011

• REC opinion

  Favourable Opinion