Trials / Completed
CompletedNCT01507896
BAX 326 Surgery Study in Hemophilia B Patients
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- Baxalta now part of Shire · Industry
- Sex
- All
- Age
- 12 Years – 65 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Recombinant factor IX | 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. |
Timeline
- Start date
- 2011-12-19
- Primary completion
- 2014-05-15
- Completion
- 2014-05-15
- First posted
- 2012-01-11
- Last updated
- 2021-05-19
- Results posted
- 2017-02-15
Locations
14 sites across 10 countries: Argentina, Bulgaria, Chile, Colombia, Czechia, Poland, Romania, Russia, Ukraine, United Kingdom
Source: ClinicalTrials.gov record NCT01507896. Inclusion in this directory is not an endorsement.