drugset / Trial / NCT01344954

Single IV Administration of TB-402 for Prophylaxis of Venous Thromboembolic Events (VTE) After Total Hip Replacement Surgery

NCT01344954

Phase 2 Completed 632 enrolled ThromboGenics BioInvent International AB · collab
RandomizedParallel-groupQuadruple-blindPrevention

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.

Timeline

Start
2011-04
Primary completion
2011-12
Completion
2012-05

Drugs

EvaluationDrugModalityDoseRoute
Comparator Rivaroxaban Other / unclassified 10 mg Oral
Subject TB-402 Monoclonal antibody 25 mg Intravenous
Subject TB-402 Monoclonal antibody 50 mg Intravenous