drugset / Trial / NCT03879135
A Study of Recombinant Von Willebrand Factor (rVWF) in Pediatric and Adult Participants With Severe Von Willebrand Disease (VWD)
Phase 3
Completed
38 enrolled
Baxalta now part of Shire
Takeda Development Center Americas, Inc. · collab
Non-randomizedParallel-groupOpen-labelPrevention
Summary
The main aim of the study is to check effectiveness of rVWF (vonicog alfa) prophylaxis based on the annualized bleeding rate (ABR) of spontaneous (not related to trauma) bleeding episodes in pediatric and adult participants during the first 12 months on study treatment. The participants will be treated with rVWF for a maximum of 3 years. Their von Willebrand Disease will be treated according to Investigational product (IP) dosing directions.
Timeline
- Start
- 2019-04-01
- Primary completion
- 2025-01-30
- Completion
- 2025-01-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | rVWF | Protein / enzyme biologic | — | — |
| Background | ADVATE | Protein / enzyme biologic | — | — |