Trials / Recruiting
RecruitingNCT05582993
A Study of Vonicog Alfa (rVWF) in Children With Severe Von Willebrand Disease (vWD)
A Phase 3, Prospective, Open-label, Uncontrolled, Multicenter Study on Efficacy and Safety of Prophylaxis With Vonicog Alfa (rVWF) in Children Diagnosed With Severe Von Willebrand Disease
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 24 (estimated)
- Sponsor
- Takeda · Industry
- Sex
- All
- Age
- 17 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Vonicog Alfa | Vonicog Alfa administered by intravenous injection. |
| BIOLOGICAL | ADVATE | ADVATE administered by intravenous injection. |
Timeline
- Start date
- 2024-11-06
- Primary completion
- 2030-04-11
- Completion
- 2030-04-11
- First posted
- 2022-10-17
- Last updated
- 2025-10-15
Locations
15 sites across 5 countries: United States, France, Ireland, Italy, Japan
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05582993. Inclusion in this directory is not an endorsement.