CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 30 enrolled
Drug / intervention
Recombinant factor IXbiological
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/NCT01507896
NCT01507896Phase 3Completed
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BAX 326 (Recombinant Factor IX): A Phase 3 Prospective, Multicenter Study Evaluating Efficacy and Safety in Previously Treated Patients With Severe (FIX Level < 1%) or Moderately Severe (FIX Level 1-2%) Hemophilia B Undergoing Surgical or Other Invasive Procedures

Baxalta now part of Shire·interventional·Posted Jan 11, 2012·Updated May 19, 2021

In Brief

A Phase 3 clinical trial evaluating Recombinant factor IX for Hemophilia B. Completed, enrolled 30 participants across 14 sites in 10 countries.

Detailed Summary

The purpose of the study is to assess the hemostatic efficacy and safety of BAX 326 in subjects with severe (FIX level \< 1%) or moderately severe (FIX level 1-2%) hemophilia B undergoing major or minor elective or emergency surgical, dental or other invasive procedures.

Study Details

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

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJan 11, 2012
Enrollment StartDec 19, 2011
Primary CompletionMay 15, 2014
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 14.5 years ago

Interventions

Recombinant factor IXbiological

Following a loading dose with BAX326, participants will receive BAX326 as a bolus infusion. The treatment regimen will be determined by the intensity and duration of the hemostatic challenge and the institution´s standard of care. The dose will be tailored to raise FIX concentration to at least 80%-100% of normal for major surgeries and to at least 30%-60% of normal for minor surgeries.