NCT00119457

Factor IX Inhibition in Thrombosis Prevention (The FIXIT Trial)

A Multi-Center, Placebo-Controlled Evaluation of the Safety and Efficacy of Three Weeks Extended VTE Prophylaxis With Daily Oral Doses of TTP889 After One Week of Standard Prophylactic Treatment Following Hip Fracture Surgery

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 300 (planned)
• Sponsor: vTv Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether TTP889 prevents venous thromboembolism following surgery to repair hip fracture.

Detailed description

FIXIT is the first Phase 2 study of TTP889. The trial is a proof-of-concept study to determine the safety and antithrombotic efficacy of TTP889 in patients at risk for venous thromboembolism (VTE). The study is a multi-center, randomized, double-blind, parallel-group evaluation of 300 mg TTP889 or placebo, administered orally once daily for three weeks, in patients who have undergone surgery to repair unilateral fracture of the upper third of either femur and who have completed 5 to 9 days of postoperative prophylactic treatment for VTE.

Conditions

• Venous Thromboembolism
• Embolism and Thrombosis
• Hip Fractures

Interventions

Type	Name	Description
DRUG	TTP889

Timeline

• Start date: 2005-01-01
• Completion: 2006-04-01
• First posted: 2005-07-13
• Last updated: 2009-06-03

Locations

21 sites across 4 countries: Czechia, Denmark, Norway, Sweden