drugset / Trial / NCT02083965
Pharmacokinetics of rFVIIIFc at Two Vial Strengths
RandomizedCrossoverOpen-labelTreatment
Summary
The primary objective of the study is to characterize the pharmacokinetics (PK) of rFVIIIFc administered at vial strengths of 1000 and 3000 IU in subjects with severe hemophilia A. The secondary objective of the study is to evaluate the safety of rFVIIIFc beyond the PK assessment for up to 6 months for a continued treatment period.
Timeline
- Start
- 2014-03
- Primary completion
- 2014-10
- Completion
- 2015-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | rFVIIIFc | Protein / enzyme biologic | 20 iu/kg | Intravenous |
| Subject | rFVIIIFc | Protein / enzyme biologic | 50 iu/kg | Intravenous |
| Subject | rFVIIIFc | Protein / enzyme biologic | 65 iu/kg | Intravenous |