Trials / Completed
CompletedNCT02973087
rVWF IN PROPHYLAXIS
A PROSPECTIVE, PHASE 3, OPEN-LABEL, INTERNATIONAL MULTICENTER STUDY ON EFFICACY AND SAFETY OF PROPHYLAXIS WITH rVWF IN SEVERE VON WILLEBRAND DISEASE
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 29 (actual)
- Sponsor
- Takeda · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this phase 3 study is to investigate the efficacy and safety, including immunogenicity, thrombogenicity and hypersensitivity reactions, as well as pharmacokinetics (PK), health related quality of life (HRQoL) and pharmacoeconomics of prophylactic treatment with recombinant von Willebrand factor (rVWF) (vonicog alfa) in adult participants with severe von Willebrand disease (VWD).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | von Willebrand factor (Recombinant) | OD participants will receive intravenous (IV) rVWF:RCo at an initial prophylactic dose of 50 +/- 10 International Unit per Kilogram (IU/kg) twice (two infusions) a week for at least 12 months up to 15 months and may be increased up to 80 IU/kg. pdVWF switch cohort participants will receive rVWF:RCo equivalent (± 10%) to the weekly VWF dose received during prophylactic treatment with pdVWF. |
| BIOLOGICAL | Antihemophilic Factor (Recombinant) | During prophylaxis period any bleeding episodes requiring substitution therapy with VWF concentrate to control bleeding will be treated with rVWF with or without ADVATE. Participants will receive rFVIII IV if necessary for OD treatment of breakthrough bleeds or for peri-operative. The dose will be according to the bleeding type and severity and it will be adjusted to the clinical response. |
Timeline
- Start date
- 2017-11-16
- Primary completion
- 2020-07-06
- Completion
- 2020-07-06
- First posted
- 2016-11-25
- Last updated
- 2021-08-06
- Results posted
- 2021-08-06
Locations
35 sites across 9 countries: United States, Canada, France, Germany, Italy, Netherlands, Russia, Spain, Turkey (Türkiye)
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02973087. Inclusion in this directory is not an endorsement.