Trials / Completed
CompletedNCT04052698
Clinical Study to Investigate the Efficacy and Safety of Wilate During Prophylaxis in Previously Treated Patients With VWD
Clinical Study to Investigate the Efficacy and Safety of Wilate During Prophylaxis in Previously Treated Patients With Von Willebrand Disease (VWD)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 43 (actual)
- Sponsor
- Octapharma · Industry
- Sex
- All
- Age
- 6 Years
- Healthy volunteers
- Not accepted
Summary
This is a prospective, non-controlled, international, multi-center phase 3 study investigating the efficacy and safety of Wilate in previously treated adult patients with VWD, to obtain additional data on the safety and efficacy of Wilate in previously treated patients with VWD undergoing regular prophylaxis.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Wilate | Produced from the plasma of human donors, Wilate is presented as a powder or solvent for intravenous injection containing normally 500 IU or 1000 IU human VWF and human FVIII per vial. The ratio between VWF ristocetin co-factor activity (VWF:RCo) and FVIII:C is 1:1. The product contains approximately 100 IU/ml human VWF when reconstituted with 5ml/10mL water for injection with 0.1% polysorbate 80. The specific activity of Wilate is ≥67 IU VWF:RCo/mg protein. The injection or infusion rate should not exceed 2-3mL per minute. |
Timeline
- Start date
- 2020-06-18
- Primary completion
- 2022-04-23
- Completion
- 2022-04-23
- First posted
- 2019-08-12
- Last updated
- 2023-10-25
- Results posted
- 2023-10-25
Locations
14 sites across 8 countries: United States, Belarus, Bulgaria, Croatia, Hungary, Lebanon, Russia, Ukraine
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04052698. Inclusion in this directory is not an endorsement.