NCT03088358

Safety and Efficacy of TeaRx Xa Factor Direct Inhibitor Versus Enoxaparin as a Venous Thromboembolic Events (VTE) Prevention Following Total Knee Replacement

A Multicenter, Randomized, Pilot, Dose-Ranging Clinical Study to Evaluate Safety and Efficacy of TeaRx Xa Factor Direct Inhibitor Versus Enoxaparin as a Venous Thromboembolic Events (VTE) Prevention Following Total Knee Replacement

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: TeaRx LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate influence of therapy on the following efficacy and safety parameters in different TeaRx dose groups and Enoxaparin group: * Total venous thromboembolic events (VTE), which includes confirmed deep venous thrombosis (DVT), nonfatal pulmonary embolism (PE), and total mortality * Incidence of DVT (total, proximal, distal) * Incidence of nonfatal PE * Incidence of symptomatic VTE (DVT, PE) * VTE caused mortality * Non-VTE caused mortality * Incidence of all hemorrhagic complications * Incidence of major and clinically relevant non-major bleeding * Adverse events (AEs) and serious adverse events (SAEs) from subject complaints, physical examination, vital signs, laboratory results

Conditions

• Total Knee Replacement

Interventions

Type	Name	Description
DRUG	TeaRx
DRUG	Enoxaparin

Timeline

• Start date: 2013-08-01
• Primary completion: 2015-09-01
• Completion: 2015-09-01
• First posted: 2017-03-23
• Last updated: 2017-03-23

Locations

8 sites across 1 country: Russia