Trials / Completed
CompletedNCT01286779
BAX 326 (rFIX) Continuation Study
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 117 (actual)
- Sponsor
- Baxalta now part of Shire · Industry
- Sex
- All
- Age
- 65 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | BAX 326 (Recombinant factor IX) | 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. |
Timeline
- Start date
- 2011-04-12
- Primary completion
- 2017-06-29
- Completion
- 2017-06-29
- First posted
- 2011-01-31
- Last updated
- 2021-05-20
- Results posted
- 2018-09-10
Locations
42 sites across 17 countries: Argentina, Brazil, Bulgaria, Chile, Colombia, Czechia, India, Ireland, Italy, Japan, Poland, Romania, Russia, Sweden, Taiwan, Ukraine, United Kingdom
Source: ClinicalTrials.gov record NCT01286779. Inclusion in this directory is not an endorsement.