NCT01174446

Pivotal Study (Pharmacokinetics, Efficacy, Safety) of BAX 326 (rFIX) in Hemophilia B Patients

Recombinant Factor IX (BAX 326): A Phase 1/3, Prospective, Controlled, Multicenter Study Evaluating Pharmacokinetics, Efficacy, Safety and Immunogenicity in Previously Treated Patients With Severe or Moderately Severe Hemophilia B

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 86 (actual)
• Sponsor: Baxalta now part of Shire · Industry
• Sex: All
• Age: 12 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this pivotal Phase 1/3 study is to determine the pharmacokinetic (PK) parameters, the hemostatic efficacy, and the safety of BAX 326, a recombinant factor IX, in previously treated patients (PTPs) with severe and moderately severe hemophilia B.

Conditions

• Hemophilia B

Interventions

Type	Name	Description
BIOLOGICAL	BAX 326	* Study Part 1: Pharmacokinetic (PK) Crossover with BAX326 and BeneFIX * Study Part 2: Open-label evaluation of prophylaxis and on-demand BAX326 only * Study Part 3: Open-label repeat of PK evaluation (repeat Study Part 1) with BAX326 only and same study participants as Study Part 1
BIOLOGICAL	BeneFIX	* Study Part 1: Pharmacokinetic (PK) Crossover with BAX326 and BeneFIX. * BeneFIX only used in Part 1 of this study. * Study Part 2 and 3 only utilized BAX326

Timeline

• Start date: 2010-07-29
• Primary completion: 2012-05-03
• Completion: 2012-05-03
• First posted: 2010-08-03
• Last updated: 2021-05-20
• Results posted: 2013-11-25

Locations

25 sites across 14 countries: Argentina, Brazil, Bulgaria, Chile, Colombia, Czechia, Japan, Poland, Romania, Russia, Spain, Sweden, Ukraine, United Kingdom