NCT00793234

Single Intravenous Administration of TB-402 for the Prophylaxis of Venous Thromboembolic Events (VTE) After Total Knee Replacement Surgery

Single Intravenous Administration of TB-402 for the Prophylaxis of Venous Thromboembolic Events (VTE) After Total Knee Replacement Surgery: A Dose-Escalating, Multicenter, Randomised, Active- Controlled Open Label Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 316 (actual)
• Sponsor: ThromboGenics · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and efficacy of a single administration of TB-402 for the prevention of VTE in patients undergoing knee replacement surgery.

Detailed description

Currently available anticoagulant therapies for the prevention of VTE include low molecular weight heparins, pentasaccharides and vitamin K antagonists, all of which have inherent limitations(1-3). Improved anticoagulant agents are therefore required(4). A novel antithrombotic agent requires demonstration of both efficacy and safety in relevant populations. Phase II studies are frequently performed in patients undergoing total hip replacement and/or total knee replacement because of the high and well documented incidence of deep vein thrombosis in the absence of adequate thromboprophylaxis(5-7). In this study, we assess the safety and efficacy of TB-402, a novel antithrombotic agent that partially inhibits factor VIII, in the prevention of VTE in patients undergoing total knee replacement surgery.

Conditions

• Total Knee Replacement Surgery

Interventions

Type	Name	Description
DRUG	TB-402	TB-402 administered as single bolus 18-24 post total knee replacement surgery.
DRUG	Enoxaparin	Enoxaparin 40mg/day sc injection for at least 10 days post-surgery

Timeline

• Start date: 2008-12-01
• Primary completion: 2010-01-01
• Completion: 2010-03-01
• First posted: 2008-11-19
• Last updated: 2014-04-07

Locations

35 sites across 7 countries: Bulgaria, Israel, Latvia, Poland, Romania, Russia, Ukraine