drugset / Trial / NCT02213250
An Open-Label, Single Dose Pharmacokinetic Study of Benefix (Recombinant Factor IX) in Male Chinese Subjects With Hemophilia B
NaSingle-groupOpen-labelTreatment
Summary
The sample size of 12 male Chinese subjects are based on the CFDA requirement for a China PK study and to support the registration in China.
Timeline
- Start
- 2015-03
- Primary completion
- 2015-04
- Completion
- 2015-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BeneFIX | Protein / enzyme biologic | 50 iu/kg | Intravenous |