drugset / Trial / NCT04565236
A Post Approval Commitment Study to Gain More Information on How Safe and Effective KOVALTRY is in Chinese Children, Adolescents /Adults With Severe Hemophilia A
Non-randomizedSingle-groupOpen-labelTreatment
Summary
The goal of this study is to gather more information on safety and efficacy of Kovaltry for the prevention and treatment of bleeds in Chinese children, adolescents/adults with severe hemophilia A. In addition, pharmacokinetic parameters of Kovaltry will be assessed in a subset of patients.
Timeline
- Start
- 2020-09-22
- Primary completion
- 2024-03-15
- Completion
- 2024-03-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ADVATE | Protein / enzyme biologic | 15 iu/kg | Intravenous |
| Subject | ADVATE | Protein / enzyme biologic | 20 iu/kg | Intravenous |
| Subject | ADVATE | Protein / enzyme biologic | 25 iu/kg | Intravenous |
| Subject | ADVATE | Protein / enzyme biologic | 40 iu/kg | Intravenous |
| Subject | ADVATE | Protein / enzyme biologic | 50 iu/kg | Intravenous |