Trials / Completed
CompletedNCT02954575
Clinical Study to Investigate the PK, Efficacy, and Safety of Wilate in Patients With Severe Hemophilia A
Clinical Study to Investigate the Pharmacokinetics, Efficacy, Safety, and Immunogenicity of Wilate in Previously Treated Patients With Severe Hemophilia A
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 57 (actual)
- Sponsor
- Octapharma · Industry
- Sex
- Male
- Age
- 12 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to obtain additional data on the safety and efficacy of Wilate in PTPs with hemophilia A with at least 150 previous exposure days (EDs) to a FVIII concentrate who undergo prophylactic treatment with Wilate for 6 months and at least 50 EDs, thus supplementing the existing database to obtain approval of Wilate for the indication hemophilia A in the USA.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Wilate |
Timeline
- Start date
- 2016-12-01
- Primary completion
- 2018-03-29
- Completion
- 2018-03-29
- First posted
- 2016-11-03
- Last updated
- 2021-01-19
- Results posted
- 2019-12-03
Locations
7 sites across 5 countries: Bulgaria, Hungary, Poland, Romania, Russia
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02954575. Inclusion in this directory is not an endorsement.