CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 117 enrolled
Drug / intervention
BAX 326 (Recombinant factor IX)biological
Likely dose
BAX 326 (Recombinant factor IX) 50 IUfrom 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/NCT01286779
NCT01286779Phase 3Completed
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BAX 326 (Recombinant Factor IX): Evaluation of Safety, Immunogenicity, and Hemostatic Efficacy in Previously Treated Patients With Severe (FIX Level < 1%) or Moderately Severe (FIX Level <= 2%) Hemophilia B - A Continuation Study

Baxalta now part of Shire·interventional·Posted Jan 31, 2011·Updated May 20, 2021

In Brief

A Phase 3 clinical trial evaluating BAX 326 (Recombinant factor IX) for Hemophilia B. Completed, enrolled 117 participants across 42 sites in 17 countries.

Detailed Summary

The purpose of this BAX 326 Continuation Study is to further investigate incremental recovery over time, the hemostatic efficacy, the safety, immunogenicity, and health-related quality of life (HR QoL) of BAX 326 in previously treated patients (PTPs) with severe and moderately severe hemophilia B who participated in BAX 326 pivotal study 250901 or BAX 326 pediatric study 251101.

Study Details

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

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJan 31, 2011
Enrollment StartApr 12, 2011
Primary CompletionJun 29, 2017
TodayJul 2, 2026
Enrollment to primary: 6.2 yearsPosted 15.4 years ago

Interventions

BAX 326 (Recombinant factor IX)biological

The treatment with BAX 326 will be at the discretion of the investigator and will consist of either twice weekly prophylactic treatment with 50 IU/kg, modified prophylaxis, or on-demand treatment.