BAX 326 (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 1-2%) Hemophilia B
Latest Information Update: 07 Nov 2021
At a glance
- Drugs Nonacog gamma (Primary)
- Indications Haemophilia B
- Focus Adverse reactions; Registrational
- Sponsors Baxter International; Shire
- 15 Sep 2014 The US FDA has approved nonacog alfa for use in children with haemophilia B based on results from this trial.
- 11 Dec 2013 New trial record
- 09 Dec 2013 Results were presented at the 55th Annual Meeting of the American Society of Hematology (ASH), according to a Baxter International media release reporting the results.