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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

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Trial Profile

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

Status: Completed
Phase of Trial: Phase II/III

Latest Information Update: 07 Nov 2021

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At a glance

  • Drugs Nonacog gamma (Primary)
  • Indications Haemophilia B
  • Focus Adverse reactions; Registrational
  • Sponsors Baxter International; Shire

Most Recent Events

  • 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.

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