Trials / Completed
CompletedNCT01344954
Single IV Administration of TB-402 for Prophylaxis of Venous Thromboembolic Events (VTE) After Total Hip Replacement Surgery
Single Intravenous Administration of TB-402 for the Prophylaxis of Venous Thromboembolic Events (VTE) After Total Hip Replacement Surgery: A Phase 2b, Multicentre, Randomised, Active-Controlled, Double Blind, Double Dummy, Parallel Group Study
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 632 (actual)
- Sponsor
- ThromboGenics · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the safety and efficacy of two doses of TB-402 administered as a single intravenous infusion for the prevention of VTE in subjects undergoing total hip replacement surgery.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | TB-402 | Administered intravenously over 10 minutes |
| DRUG | Rivaroxaban | Administered orally as a capsule once a day for 35 days |
| DRUG | TB-402 | Administered intravenously over 10 minutes |
Timeline
- Start date
- 2011-04-01
- Primary completion
- 2011-12-01
- Completion
- 2012-05-01
- First posted
- 2011-04-29
- Last updated
- 2012-08-23
Locations
36 sites across 9 countries: Austria, Belgium, Bulgaria, Hungary, Latvia, Netherlands, Poland, Russia, Ukraine
Source: ClinicalTrials.gov record NCT01344954. Inclusion in this directory is not an endorsement.