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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01344954

Enrollment

632

Registered

2011-04-29

Start date

2011-04-30

Completion date

2012-05-31

Last updated

2012-08-23

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

Conditions

Prophylaxis of Venous Thromboembolic Events

Brief summary

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.

Interventions

DRUGTB-402

Administered intravenously over 10 minutes

DRUGRivaroxaban

Administered orally as a capsule once a day for 35 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Male or female subjects aged ≥ 18 years. 2. Written informed consent. 3. Willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures

Exclusion criteria

1. Pregnancy at the time of screening. 2. Indication for anticoagulation other than post-operative thromboprophylaxis. 3. Active bleeding or high risk of bleeding. 4. Anticipated continued use of neuraxial catheter after surgery. 5. Clinical laboratory findings at screening of thrombocytopenia or prolonged aPTT or PT. 6. Uncontrolled hypertension. 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 (\< 200mg). 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
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

Measure	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

Countries

Austria, Belgium, Bulgaria, Hungary, Latvia, Netherlands, Poland, Russia, Ukraine

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026