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NCT02932618 · ClinicalTrials.gov registry record · Phase 3
A Study of Recombinant Von Willebrand Factor (rVWF) With or Without ADVATE in Children With Severe Von Willebrand Disease (VWD)
A Phase 3 study of Von Willebrand Disease, sponsored by Baxalta now part of Shire.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 31
- Enrollment target
- 20
- Study locations
NCT02932618: Recruiting Phase 3 study of Von Willebrand Disease, sponsored by Baxalta now part of Shire.
NCT02932618 is a Phase 3 study of Von Willebrand Disease that is actively recruiting participants, run by Baxalta now part of Shire. The registered enrollment target is 31 participants, above the 22-participant average among 3 other Von Willebrand Disease trials with a reported enrollment target (41% higher). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02932618, a Phase 3 study of Von Willebrand Disease, is actively recruiting participants, sponsored by Baxalta now part of Shire.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 31 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
Treatment success for vonicog alfa-treated nonsurgical bleeding episodes (using a 4-point scale: Excellent, Good, Moderate, None).
Conditions Studied
Interventions
- BIOLOGICAL Vonicog alfa
- BIOLOGICAL Antihemophilic Factor (Recombinant)
Study Locations (20)
Other
- Medizinische Universität Innsbruck - Innsbruck
- AKH - Medizinische Universität Wien - Vienna
- UZ Leuven - Leuven
- Fakultni nemocnice Brno - Brno
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
- Rainbow Babies and Children's Hospital - Cleveland
- Nationwide Children's Hospital - Columbus
North Carolina
- St. Jude Affiliate Clinic at Novant Health - Charlotte
- Comprehensive Cancer Center of Wake Forest Unversity - Winston-Salem
Texas
- Texas Children's Cancer and Hematology Center - Houston
- Texas Children's Hospital - Houston
Colorado
- University of Colorado Hemophilia & Thrombosis Center - Aurora
District of Columbia
- Children's National Medical Center - Washington D.C.
Florida
- University of Florida College of Medicine - Jacksonville
Illinois
- Bleeding and Clotting Disorders Institute - Peoria
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2017-11-06 |
| Est. Completion | 2026-03-31 |
| Phase | Phase 3 |
What NCT02932618 shows while recruiting
NCT02932618 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, above the 22-participant average among 3 other Von Willebrand Disease trials with a reported enrollment target (41% higher).
The record links to 1 condition, with Von Willebrand Disease appearing as the primary indexed condition, and to 2 interventions - of which Vonicog alfa is the first listed.
NCT02932618 names 20 study sites across 13 states, led by Other, Ohio, North Carolina.
Frequently Asked Questions
What is clinical trial NCT02932618 about?
NCT02932618 is a clinical study titled "A Study of Recombinant Von Willebrand Factor (rVWF) With or Without ADVATE in Children With Severe Von Willebrand Disease (VWD)". 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 ...
What is the current status of trial NCT02932618?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 31 participants. The study started on 2017-11-06. Estimated completion is 2026-03-31.
What conditions does trial NCT02932618 study?
This clinical trial studies the following conditions: Von Willebrand Disease.
What interventions are being tested in trial NCT02932618?
The interventions under investigation include: Vonicog alfa (BIOLOGICAL), Antihemophilic Factor (Recombinant) (BIOLOGICAL).
Who is sponsoring clinical trial NCT02932618?
This trial is sponsored by Baxalta now part of Shire, which has 74 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02932618 being conducted?
This trial has 20 study locations across Colorado, District of Columbia, Florida, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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