drugset / Trial / NCT02048111
Study of Recombinant Factor IX Product, IB1001, in Previously Treated Subjects With Hemophilia B
NaSingle-groupOpen-labelSupportive care
Summary
To evaluate the safety (acute adverse effects associated with infusions, and inhibitor development), pharmacokinetics (PK), and efficacy with respect to breakthrough bleeding and control of hemorrhaging during prophylaxis of IB1001 in subjects with hemophilia B.
Timeline
- Start
- 2014-03
- Primary completion
- 2015-10
- Completion
- 2015-11
Outcome
Outcome not reported
Stopped: “The study was withdrawn from the IND.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | trenonacog alfa | Protein / enzyme biologic | 40 iu/kg | — |
| Subject | trenonacog alfa | Protein / enzyme biologic | 60 iu/kg | — |
| Subject | trenonacog alfa | Protein / enzyme biologic | 75 iu/kg | — |