drugset / Trial / NCT00716716
Phase I/IIa Study of FIXFc in Hemophilia B Patients
Phase 1
Completed
10 enrolled
Bioverativ Therapeutics Inc.
Swedish Orphan Biovitrum · collabSyntonix Pharmaceuticals, Inc. · collab
NaSingle-groupOpen-labelTreatment
Summary
The primary objective of the study is to assess safety of FIXFc at doses ranging from 1 to 100 IU/kg.
Timeline
- Start
- 2008-04
- Primary completion
- 2009-10
- Completion
- 2009-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | EFTRENONACOG ALFA | Protein / enzyme biologic | 1 iu/kg | Intravenous |
| Subject | EFTRENONACOG ALFA | Protein / enzyme biologic | 5 iu/kg | Intravenous |
| Subject | EFTRENONACOG ALFA | Protein / enzyme biologic | 12.5 iu/kg | Intravenous |
| Subject | EFTRENONACOG ALFA | Protein / enzyme biologic | 25 iu/kg | Intravenous |
| Subject | EFTRENONACOG ALFA | Protein / enzyme biologic | 50 iu/kg | Intravenous |
| Subject | EFTRENONACOG ALFA | Protein / enzyme biologic | 100 iu/kg | Intravenous |