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

August 22, 2012 updated by: ThromboGenics

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

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.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

632

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Linz, Austria
        • KRANKENHAUS DES BARMHER.SCHW.Linz
      • Wels, Austria
        • Klinikum Wels-Grieskirchen GmbH
      • Wien, Austria
        • Akh Wien
      • Wien, Austria
        • Orthopädisches Spital Speising
      • Antwerpen, Belgium
        • ZNA Antwerpen Locatie Middelheim
      • Pleven, Bulgaria
        • SHAT of orthopedics, traumatology and surgery "Sv. Pantaleimon " - Pleven Department of Orthopaedics and Traumatology
      • Plovdiv, Bulgaria
        • Department of Orthopedics, UMHAT "Sv. Georgi"
      • Rousse, Bulgaria
        • MHAT Rousse, Department of Orthopaedics
      • Sofia, Bulgaria
        • UMHAT "St Anna" AD,Clinic of Orthopaedics and Traumatology
      • Sofia, Bulgaria
        • UMHAT 'Tsaritsa Joanna'
      • Gyula, Hungary
        • Pandy Kalman Korhaz
      • Kecskemét, Hungary
        • Bács-Kiskun Megyei Önkormányzat Kórháza, Szegedi Tudományegyetem Általános Orvostudományi Karháza
      • Szekszárd, Hungary
        • Tolna Megyei Önkormányzat Balassa János Kórháza
      • Adazi, Latvia
        • Traumatology and Orthopedics Clinic "Adazi", LTD
      • Liepāja, Latvia
        • Ltd "Liepajas regionala slimnica"
      • Riga, Latvia
        • Riga 2nd Hospital
      • Valmiera, Latvia
        • Ltd "Vidzemes slimnica"
      • Leiden, Netherlands
        • Diaconessenhuis Leiden
      • Bialystok, Poland
        • Klinika Orthopedii I Traumatologii
      • Puszczykowo, Poland
        • NZOZ Szpital w Puszczykowie
      • Warsaw, Poland
        • Medical University of warsaw, Dept of Orthopaedics
      • Warszawa, Poland
        • Klinika Ortopedii, WIM
      • Łódź, Poland
        • Wojewódzkie Centrum Ortopedii i Rehabilitacji Narządu Ruchu im. dr Z. Radlińskiego w Łodzi
      • Chelabinsk, Russian Federation
        • Municipal Healthcare Institution "City Clinical Hospital No. 3"
      • Orenburg, Russian Federation
        • Municipal Healthcare Medical Institution "City Clinical Hospital No. 4"
      • Saint-Petersburg, Russian Federation
        • Federal State Healthcare Institution: Clinical Hospital #122 named after L.G. Sokolov under the Federal Medical-Biological Agency of Russia
      • Saint-Petersburg, Russian Federation
        • Saint Petersburg State Healthcare Institution "City Aleksandrovskaya Hospital"
      • Saint-Petersburg, Russian Federation
        • Saint Petersburg State Healthcare Institution "Municipal Multi-Speciality Hospital No. 2"
      • Samara, Russian Federation
        • State Healthcare Institution "Samara Regional Clinical Hospital n.a. M.I. Kalinin"
      • Yaroslavl, Russian Federation
        • Municipal Healthcare Institution "Clinical Hospital of Emergency Care n.a. N.V. Soloviov"
      • Cherkassy, Ukraine
        • Public Entity "Regional Hospital - Center of Emergency Medical Care and Disaster Medicine" of Cherkasy Regional Council, Department of orthopedy and traumatology
      • Ivano-Frankivsk, Ukraine
        • Ivano-Frankіvsk Regional Clinical Hospital MoH Ukraine, Department of ortopedics and traumatology. Department of traumatology, ortopedics and military/emergency surgery of Ivano-Frankіvsk National Medical University
      • Kharkiv, Ukraine
        • SE "Sytenko Institute of Spine and Joint Pathology, AMS Ukraine", department of orthopedic arthrology and endoprosthesis replacement
      • Kyiv, Ukraine
        • Public Entity of Kyiv Regional council "Kyiv Regional Clinical Hospital", Ortopedy and traumatology center of Public Entity of Kyiv Regional council "Kyiv Regional Clinical Hospital"
      • Odessa, Ukraine
        • Public Establishment "Odessa Regional Clinical Hospital", Department of Orthopedics and Traumatology.
      • Sevastopol, Ukraine
        • Public Establishment 'City Hospital #9', orthopedy and traumatology department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 25mg TB-402
Administered intravenously over 10 minutes
Experimental: 50mg TB-402
Administered intravenously over 10 minutes
Active Comparator: 10mg QD Rivaroxaban
Administered orally as a capsule once a day for 35 days
Other Names:
  • Xarelto

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

March 18, 2011

First Submitted That Met QC Criteria

April 28, 2011

First Posted (Estimate)

April 29, 2011

Study Record Updates

Last Update Posted (Estimate)

August 23, 2012

Last Update Submitted That Met QC Criteria

August 22, 2012

Last Verified

August 1, 2012

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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