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

• Status: Completed
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ThromboGenics
• Collaborators: BioInvent International AB; Covance
• Treatments: Enoxaparin

Criteria

Inclusion Criteria:

• Male or female patients aged > 18 and < 80 years old

• Female patients should be post menopausal

• Patients undergoing primary elective total knee replacement surgery

• Written informed consent obtained from the patient (or a legally acceptable representative) prior to inclusion in the study

• Willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures

Exclusion Criteria:

• Body weight < 50 kg or > 100 kg

• Patients undergoing a hemiarthroplasty, surface repair or revisionary surgery of the knee

• Confirmed symptomatic deep vein thrombosis or pulmonary embolism within the past year

• Anticipated use of indwelling intrathecal or epidural catheter for more than 4 h after surgery or during the entire study

• Uncontrolled hypertension (SBP>160 mm Hg or DBP > 100 mm Hg)

• History of intracranial or intraocular bleeding. History of gastrointestinal and/or endoscopically verified ulcer disease within the past year