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

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and efficacy of two doses of TB-402 administered as a single intravenous infusion for the prevention of VTE in subjects undergoing total hip replacement surgery.

Official Title
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Single Intravenous Administration of TB-402 for the Prophylaxis of Venous Thromboembolic Events (VTE) After Total Hip Replacement Surgery: A Phase 2b, Multicentre, Randomised, Active-Controlled, Double Blind, Double Dummy, Parallel Group Study

Conditions
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Prophylaxis of Venous Thromboembolic Events

Intervention / Treatment
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* Drug: TB-402
* Drug: Rivaroxaban
* Drug: TB-402


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 25mg TB-402<br> | Drug: TB-402<br>* Administered intravenously over 10 minutes<br>|
| Experimental: 50mg TB-402<br> | Drug: TB-402<br>* Administered intravenously over 10 minutes<br>|
| Active Comparator: 10mg QD Rivaroxaban<br> | Drug: Rivaroxaban<br>* Administered orally as a capsule once a day for 35 days<br>* Other names: Xarelto;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite of asymptomatic DVT as detected by bilateral venography and symptomatic VTE, i.e. DVT or fatal or non-fatal PE |  | Randomisation to post-operative day 35 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidents of major VTE |  | Randomisation to Post-Operative day 35 | 
| Incidents of total DVT |  | Randomisation to Post-Operative day 35 | 
| Incidents of proximal/distal DVT |  | Randomisation to Post-Operative day 35 | 
| Incidents of pulmonary embolism |  | Randomisation to Post-Operative day 35 | 
| Incidents of VTE-related death |  | Randomisation to Post-Operative day 35 | 
| Incidents of Major VTE |  | Randomisation to Post-Operative day 70 |