drugset / Trial / NCT02246894
A Study to Investigate the Safety and Efficacy of Optivate® in Children Under 6 Years of Age With Haemophilia A.
Summary
The main objectives of this study are: * to assess Optivate® consumption (IU/kg consumed per month for prophylactic and on-demand therapy and dose at each bleed). * to assess clinical outcome when treating a bleed with Optivate®. * to evaluate Optivate® in terms of clinical tolerance and safety in children under the age of 6 years. . * to assess FVIII inhibitor development during the study.
Timeline
- Start
- 2003-11
- Primary completion
- 2005-01
- Completion
- —
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Wilate | Protein / enzyme biologic | — | — |