Trials / Completed
CompletedNCT01992549
Study to Investigate Immunogenicity, Efficacy and Safety of Treatment With Human-cl rhFVIII
Extension Study for Patients Who Completed GENA-05 (NuProtect)- to Investigate Immunogenicity, Efficacy and Safety of Treatment With Human-cl rhFVIII
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 48 (actual)
- Sponsor
- Octapharma · Industry
- Sex
- Male
- Age
- —
- Healthy volunteers
- Not accepted
Summary
The purpose of the study is to collect long-term data on the inhibitor development rate of Human-cl rhFVIII in previously untreated patients with severe Hemophilia A.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Human-cl rhFVIII |
Timeline
- Start date
- 2014-04-01
- Primary completion
- 2018-12-27
- Completion
- 2018-12-27
- First posted
- 2013-11-25
- Last updated
- 2021-01-19
- Results posted
- 2019-12-17
Locations
15 sites across 9 countries: United States, Canada, France, Georgia, India, Moldova, Poland, Ukraine, United Kingdom
Source: ClinicalTrials.gov record NCT01992549. Inclusion in this directory is not an endorsement.