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.

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-023383-40-BE

Enrollment

600

Registered

2011-01-04

Start date

2011-02-15

Completion date

Unknown

Last updated

2022-01-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Venous Thromboembolic Event MedDRA version: 14.0 Level: LLT Classification code 10049909 Term: Venous thromboembolism prophylaxis System Organ Class: 10042613 - Surgical and medical procedures

Interventions

Product Name: TB-402 Product Code: TB-402 Pharmaceutical Form: Solution for infusion INN or Proposed INN: TB-402 Current Sponsor code: TB-402 Concentration unit: mg/ml milligram(s)/millilitre Concentr

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
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. 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 randomisation to post-operative Day 35 inclusive; VTE events for the primary analysis will be based on the adjudicated evaluation.	—

Measure

Time frame

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. 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 randomisation to post-operative Day 35 inclusive; VTE events for the primary analysis will be based on the adjudicated evaluation.

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Secondary

Measure	Time frame
Secondary end point(s): Secondary Efficacy Outcomes are as follows: - Objectively confirmed major VTE (proximal DVT, symptomatic DVT, PE, VTE related death) from randomisation to post-operative Day 35 inclusive - Total DVT from randomisation to post-operative Day 35 inclusive - Proximal DVT from randomisation to post-operative Day 35 inclusive - Distal DVT from randomisation to post-operative Day 35 inclusive - PE from randomisation to post-operative Day 35 inclusive - VTE-related death from randomisation to post-operative Day 35 inclusive - Objectively confirmed major VTE from randomisation to post-operative Day 70 inclusive;Timepoint(s) of evaluation of this end point: As mentioned above	—

Measure

Time frame

Secondary end point(s): Secondary Efficacy Outcomes are as follows: - Objectively confirmed major VTE (proximal DVT, symptomatic DVT, PE, VTE related death) from randomisation to post-operative Day 35 inclusive - Total DVT from randomisation to post-operative Day 35 inclusive - Proximal DVT from randomisation to post-operative Day 35 inclusive - Distal DVT from randomisation to post-operative Day 35 inclusive - PE from randomisation to post-operative Day 35 inclusive - VTE-related death from randomisation to post-operative Day 35 inclusive - Objectively confirmed major VTE from randomisation to post-operative Day 70 inclusive;Timepoint(s) of evaluation of this end point: As mentioned above

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Countries

Austria, Belgium, Bulgaria, Hungary, Latvia, Netherlands, Poland, Russian Federation, Ukraine

Contacts

Public ContactClinical Project Manager

ThromboGenics

sophie.gunn@thrombogenics.com+353 1 409 7757

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026