Long-Term Safety and Efficacy of rFIXFc in the Prevention and Treatment of Bleeding Episodes in Previously Treated Participants With Hemophilia B
| Status: | Completed |
|---|---|
| Conditions: | Hematology |
| Therapuetic Areas: | Hematology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 11/24/2018 |
| Start Date: | December 8, 2011 |
| End Date: | October 2017 |
An Open-Label, Multicenter, Evaluation of the Long-Term Safety and Efficacy of Recombinant Human Coagulation Factor IX Fusion Protein (rFIXFc) in the Prevention and Treatment of Bleeding Episodes in Previously Treated Subjects With Hemophilia B
The primary objective of the study is to evaluate the long-term safety of rFIXFc in
participants with hemophilia B.
The secondary objective of this study is to evaluate the efficacy of rFIXFc in the prevention
and treatment of bleeding episodes.
participants with hemophilia B.
The secondary objective of this study is to evaluate the efficacy of rFIXFc in the prevention
and treatment of bleeding episodes.
Participants will follow either a prophylaxis or on-demand regimen. The starting dose in this
study will be determined by the clinical profile of the patient in the preceding studies,
B-LONG 998HB102 (NCT01027364) and Kids B-LONG study 9HB02PED (NCT01440946)
study will be determined by the clinical profile of the patient in the preceding studies,
B-LONG 998HB102 (NCT01027364) and Kids B-LONG study 9HB02PED (NCT01440946)
Key Inclusion Criteria:
- Subjects who have completed studies 998HB102 (NCT01027364) or 9HB02PED (NCT01440946)
or other studies with rFIXFc
- Ability to understand the purposes & risks of the study and provide signed and dated
informed consent.
Key Exclusion Criteria:
- High-titer inhibitor (>/=5.00 BU/mL)
NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
We found this trial at
11
sites
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