Trials / Completed
CompletedNCT01575756
Pharmacokinetic, Efficacy, and Safety Study of Octafibrin Compared to Haemocomplettan/Riastap
A Prospective, Controlled, Randomised, Crossover Study Investigating the Pharmacokinetic Properties, Surrogate Efficacy and Safety of Octafibrin Compared to Haemocomplettan® P/RiaSTAPTM in Patients With Congenital Fibrinogen Deficiency
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 22 (actual)
- Sponsor
- Octapharma · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to investigate pharmacokinetic properties, surrogate efficacy and safety of Octafibrin compared to Haemocomplettan® P/RiaSTAPTM in patients with congenital fibrinogen deficiency
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Octafibrin | Octafibrin was supplied as a powder for reconstitution with water for injection. |
| BIOLOGICAL | Haemocomplettan® P or RiaSTAPTM | Commercially available Haemocomplettan® P or RiaSTAPTM (same product with different names in different markets) were supplied as powders for reconstitution with water for injection. |
Timeline
- Start date
- 2013-06-01
- Primary completion
- 2015-01-01
- Completion
- 2015-01-01
- First posted
- 2012-04-11
- Last updated
- 2018-03-09
- Results posted
- 2016-11-30
Locations
10 sites across 6 countries: United States, Bulgaria, India, Iran, Switzerland, United Kingdom
Source: ClinicalTrials.gov record NCT01575756. Inclusion in this directory is not an endorsement.