CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 86 enrolled
Drug / intervention
BAX 326 +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01174446
NCT01174446Phase 3Completed
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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

Baxalta now part of Shire·interventional·Posted Aug 3, 2010·Updated May 20, 2021

In Brief

A Phase 3 clinical trial evaluating BAX 326 and BeneFIX for Hemophilia B. Completed, enrolled 86 participants across 25 sites in 14 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHemophilia B
CountriesArgentina, Brazil, Bulgaria, Chile, Colombia, Czechia, Japan, Poland, Romania, Russia, Spain, Sweden, Ukraine, United Kingdom
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedAug 3, 2010
Enrollment StartJul 29, 2010
Primary CompletionMay 3, 2012
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 15.9 years ago

Interventions

BAX 326biological

* 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

BeneFIXbiological

* 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