A clinical study to assess the safety and efficacy of TB-402 for the prevention of formation of blood clots in the legs or lungs after hip replacement surgery.
- Conditions
- Venous Thromboembolic EventMedDRA version: 14.0Level: LLTClassification code 10049909Term: Venous thromboembolism prophylaxisSystem Organ Class: 10042613 - Surgical and medical proceduresTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
- Registration Number
- EUCTR2010-023383-40-BE
- Lead Sponsor
- ThromboGenics N.V
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 600
1. Male or female subjects aged = 18 years old scheduled for elective total hip replacement surgery.
2. Written informed consent.
3. Willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 600
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 600
1. Pregnancy at the time of screening based on a urine or blood pregnancy test or not using a reliable method of birth control.
2. Indication for anticoagulation other than post-operative thromboprophylaxis.
3. Active bleeding or high risk of bleeding contraindicating anticoagulant treatment according to the investigator.
4. Anticipated continued use of neuraxial catheter after surgery.
5. Clinical laboratory findings at screening of thrombocytopenia or prolonged aPTT or PT such that anticoagulation is contraindicated according to the investigator
6. Uncontrolled hypertension according to the investigator.
7. Impaired liver function (transaminase >3 X ULN) or history of hepatic insufficiency.
8. Creatinine clearance <30 mL/min.
9. Antiplatelet agents other than low dose aspirin (< 200 mg).
10. The use of intermittent pneumatic compression.
11. Known hypersensitivity to contrast media or rivaroxaban.
12. Known drug or alcohol abuse.
13. Active malignant disease or current cytostatic treatment.
14. Stroke within the previous month.
15. Participation in an investigational drug study within the past 30 days or previous participation in this study.
16. 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective 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.;Secondary Objective: NA;Primary end point(s): The primary efficacy outcome is the composite of the occurrence of asymptomatic DVT as detected by bilateral venography and symptomatic VTE, i.e. DVT or fatal or non-fatal PE from randomisation to post-operative Day 35 inclusive.<br><br>The principle safety outcome is major bleeding or clinically relevant non-major bleeding from randomisation to post-operative Day 35 inclusive.;Timepoint(s) of evaluation of this end point: The primary efficacy outcome is the composite of the occurrence of asymptomatic DVT as detected by bilateral venography and symptomatic VTE, i.e., DVT or fatal or non-fatal PE, from<br>randomisation to post-operative Day 35 inclusive; VTE events for the primary analysis will be based on the adjudicated evaluation.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Secondary Efficacy Outcomes are as follows:<br>- Objectively confirmed major VTE (proximal DVT, symptomatic DVT, PE, VTE related death) from randomisation to post-operative Day 35 inclusive<br>- Total DVT from randomisation to post-operative Day 35 inclusive<br>- Proximal DVT from randomisation to post-operative Day 35 inclusive<br>- Distal DVT from randomisation to post-operative Day 35 inclusive<br>- PE from randomisation to post-operative Day 35 inclusive<br>- VTE-related death from randomisation to post-operative Day 35 inclusive<br>- Objectively confirmed major VTE from randomisation to post-operative Day 70 inclusive;Timepoint(s) of evaluation of this end point: As mentioned above