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Clinical trial

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

NCT01488994 is registered in ClinicalTrials.gov with Baxalta now part of Shire as lead sponsor.

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Registry record

As filed in ClinicalTrials.gov.

Title
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
Lead sponsor
Baxalta now part of Shire
Phase
Phase 2/3
Overall status
Completed
Start date
December 20, 2011
Completion date
May 14, 2013
Enrollment
23 (actual)
Sites
11

Conditions

As the registry lists them; a condition with its own page is linked.