drugset / Trial / NCT00989196
Clinical Study to Investigate the Pharmacokinetics, Efficacy, Safety and Immunogenicity of a Recombinant FVIII in Patients With Severe Hemophilia A
RandomizedCrossoverOpen-labelTreatment
Summary
This is a clinical study to investigate the pharmacokinetics, efficacy, safety and immunogenicity of human-cl rhFVIII, a newly developed human cell-line derived recombinant FVIII concentrate in previously treated patients with severe Hemophilia A.
Timeline
- Start
- 2010-05
- Primary completion
- 2011-10
- Completion
- 2012-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | ADVATE | Protein / enzyme biologic | 50 iu/kg | — |
| Subject | simoctocog alfa | Protein / enzyme biologic | 50 iu/kg | — |