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

Inclusion criteria

• Male or female subjects aged ≥ 18 years.
• Written informed consent.
• Willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures

Exclusion criteria

• Pregnancy at the time of screening.
• Indication for anticoagulation other than post-operative thromboprophylaxis.
• Active bleeding or high risk of bleeding.
• Anticipated continued use of neuraxial catheter after surgery.
• Clinical laboratory findings at screening of thrombocytopenia or prolonged aPTT or PT.
• Uncontrolled hypertension.
• Impaired liver function (transaminase >3 X ULN) or history of hepatic insufficiency.
• Creatinine clearance <30 mL/min.
• Antiplatelet agents other than low dose aspirin (< 200mg).
• The use of intermittent pneumatic compression.
• Known hypersensitivity to contrast media or rivaroxaban.
• Known drug or alcohol abuse.
• Active malignant disease or current cytostatic treatment.
• Stroke within the previous month.
• Participation in an investigational drug study within the past 30 days or previous participation in this study.
• Any condition that in the opinion of the investigator would put the subject at increased risk from participating in the study or expected inability to comply with the protocol.