drugset / Trial / NCT00629837
Pharmacokinetics and Safety of a Single Intravenous Infusion of BAY 79-4980
RandomizedCrossoverTriple-blindTreatment
Summary
The primary objective of this study is to determine the pharmacokinetic profile after single administration of two doses of BAY 79-4980 (high and low: 35 IU FVIII/Kg reconstituted in 22 mg and 13 mg of liposomes/Kg, respectively) compared to rFVIII-FS (35 IU/Kg reconstituted in 2.5 mL WFI/1000 IU) in PTPs aged 12 to 60 years with severe hemophilia A.
Timeline
- Start
- 2005-09
- Primary completion
- —
- Completion
- 2006-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ADVATE | Protein / enzyme biologic | 35 iu/kg | — |
| Subject | BAY79-4980 | Protein / enzyme biologic | 13 mg/kg | Intravenous |
| Subject | BAY79-4980 | Protein / enzyme biologic | 22 mg/kg | Intravenous |