drugset / Trial / NCT05582993
A Study of Vonicog Alfa (rVWF) in Children With Severe Von Willebrand Disease (vWD)
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The main aim of the study is to evaluate the effectiveness of prophylaxis with vonicog alfa (recombinant von Willebrand factor \[rVWF\]) in children. This study will enroll those participants who have been previously treated with VWF product or with a plasma-derived VWF (pdVWF) product. In this study, participants will be treated with vonicog alfa (rVWF) for 12 months. During the study, participants will visit the study clinic 5 times after treatment initiation.
Timeline
- Start
- 2024-11-06
- Primary completion
- 2030-04-11
- Completion
- 2030-04-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Vonicog Alfa | Protein / enzyme biologic | 40 iu/kg | Intravenous |
| Subject | Vonicog Alfa | Protein / enzyme biologic | 60 iu/kg | Intravenous |
| Background | ADVATE | Protein / enzyme biologic | — | Intravenous |