Trials / Recruiting
RecruitingNCT02932618
A Study of Recombinant Von Willebrand Factor (rVWF) With or Without ADVATE in Children With Severe Von Willebrand Disease (VWD)
A Phase 3, Prospective, Multicenter, Uncontrolled, Open-Label Clinical Study to Determine the Efficacy, Safety, and Tolerability of rVWF With or Without ADVATE in the Treatment and Control of Bleeding Episodes, the Efficacy and Safety of rVWF in Elective and Emergency Surgeries, and the Pharmacokinetics (PK) of rVWF in Children Diagnosed With Severe Von Willebrand Disease
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 31 (estimated)
- Sponsor
- Baxalta now part of Shire · Industry
- Sex
- All
- Age
- 17 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Vonicog alfa | Lyophilized powder and solvent to prepare solution for injection. |
| BIOLOGICAL | Antihemophilic Factor (Recombinant) | Packaged in single boxes with 2 glass vials, with one vial containing the lyophilized ADVATE and the second vial containing the diluent. |
Timeline
- Start date
- 2017-11-06
- Primary completion
- 2026-03-31
- Completion
- 2026-03-31
- First posted
- 2016-10-13
- Last updated
- 2025-04-30
Locations
46 sites across 13 countries: United States, Austria, Belgium, Czechia, France, Germany, Italy, Netherlands, Russia, Spain, Turkey (Türkiye), Ukraine, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02932618. Inclusion in this directory is not an endorsement.