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

Phase 2

Completed

• Conditions: Prophylaxis of Venous Thromboembolic Events
• Interventions: Drug: Rivaroxaban; Drug: TB-402

• Registration Number: NCT01344954
• Lead Sponsor: ThromboGenics

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-03-18
• Study Start: 2011-04
• Study First Submitted QC: 2011-04-28
• Study First Posted: 2011-04-29
• Primary Completion: 2011-12
• Study Completion: 2012-05
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-22
• Last Update Posted: 2012-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 632

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
10mg QD Rivaroxaban	Rivaroxaban	-
25mg TB-402	TB-402	-
50mg TB-402	TB-402	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Incidents of total DVT	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 35
Incidents of proximal/distal DVT	Randomisation to Post-Operative day 35
Incidents of pulmonary embolism	Randomisation to Post-Operative day 35
Incidents of Major VTE	Randomisation to Post-Operative day 70

Trial Locations

Locations (36)

KRANKENHAUS DES BARMHER.SCHW.Linz; 🇦🇹 Linz, Austria

Klinikum Wels-Grieskirchen GmbH; 🇦🇹 Wels, Austria

AKH Wien; 🇦🇹 Wien, Austria

Orthopädisches Spital Speising; 🇦🇹 Wien, Austria

ZNA Antwerpen Locatie Middelheim; 🇧🇪 Antwerpen, Belgium

SHAT of orthopedics, traumatology and surgery "Sv. Pantaleimon " - Pleven Department of Orthopaedics and Traumatology; 🇧🇬 Pleven, Bulgaria

Department of Orthopedics, UMHAT "Sv. Georgi"; 🇧🇬 Plovdiv, Bulgaria

MHAT Rousse, Department of Orthopaedics; 🇧🇬 Rousse, Bulgaria

UMHAT "St Anna" AD,Clinic of Orthopaedics and Traumatology; 🇧🇬 Sofia, Bulgaria

UMHAT 'Tsaritsa Joanna'; 🇧🇬 Sofia, Bulgaria

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