drugset / Trial / NCT02932618
A Study of Recombinant Von Willebrand Factor (rVWF) With or Without ADVATE in Children With Severe Von Willebrand Disease (VWD)
Phase 3
Completed
47 enrolled
Baxalta now part of Shire
Takeda Development Center Americas, Inc. · collab
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The main aim of the study is to check effectiveness, side effects, and tolerability of vonicog alfa (recombinant von Willebrand factor \[rVWF\]), with or without ADVATE, in the treatment and control of nonsurgical bleeding events in pediatric participants (less than (\<)18 years of age) with severe hereditary von Willebrand disease (VWD). The participants will be treated with vonicog alfa for 12-18 months. Their von Willebrand Disease will be treated by their doctor according to their doctor's usual clinical practice. During the study, participants will be followed up at clinics or over telephone calls.
Timeline
- Start
- 2017-11-06
- Primary completion
- 2026-04-17
- Completion
- 2026-04-17
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ADVATE | Protein / enzyme biologic | — | — |
| Subject | Vonicog Alfa | Protein / enzyme biologic | — | — |