Trials / Completed
CompletedNCT02267226
Efficacy and Safety Study of Octafibrin for On-demand Treatment of Acute Bleeding and to Prevent Bleeding During and After Surgery
Prospective, Open-label, Uncontrolled, Phase III Study to Assess the Efficacy and Safety of Octafibrin for On-demand Treatment of Acute Bleeding and to Prevent Bleeding During and After Surgery in Subjects With Congenital Fibrinogen Deficiency
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 25 (actual)
- Sponsor
- Octapharma · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of the study is to assess the efficacy and safety of Octafibrin for on-demand treatment of acute bleeding in subjects with congenital fibrinogen deficiency.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Octafibrin |
Timeline
- Start date
- 2014-09-01
- Primary completion
- 2018-02-14
- Completion
- 2018-02-14
- First posted
- 2014-10-17
- Last updated
- 2021-01-15
- Results posted
- 2019-02-20
Locations
12 sites across 9 countries: United States, Bulgaria, India, Iran, Lebanon, Russia, Saudi Arabia, Turkey (Türkiye), United Kingdom
Source: ClinicalTrials.gov record NCT02267226. Inclusion in this directory is not an endorsement.