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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01344954
Recruitment Status : Completed
First Posted : April 29, 2011
Last Update Posted : August 23, 2012
BioInvent International AB
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Prophylaxis of Venous Thromboembolic Events Drug: TB-402 Drug: Rivaroxaban Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 632 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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
Study Start Date : April 2011
Primary Completion Date : December 2011
Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hip Replacement
Drug Information available for: Rivaroxaban
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 25mg TB-402 Drug: TB-402
Administered intravenously over 10 minutes
Experimental: 50mg TB-402 Drug: TB-402
Administered intravenously over 10 minutes
Active Comparator: 10mg QD Rivaroxaban Drug: Rivaroxaban
Administered orally as a capsule once a day for 35 days
Other Name: Xarelto

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Incidents of major VTE [ Time Frame: Randomisation to Post-Operative day 35 ]
  2. Incidents of total DVT [ Time Frame: Randomisation to Post-Operative day 35 ]
  3. Incidents of proximal/distal DVT [ Time Frame: Randomisation to Post-Operative day 35 ]
  4. Incidents of pulmonary embolism [ Time Frame: Randomisation to Post-Operative day 35 ]
  5. Incidents of VTE-related death [ Time Frame: Randomisation to Post-Operative day 35 ]
  6. Incidents of Major VTE [ Time Frame: Randomisation to Post-Operative day 70 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01344954

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Sponsors and Collaborators
BioInvent International AB

Responsible Party: ThromboGenics Identifier: NCT01344954     History of Changes
Other Study ID Numbers: TB-402-006
First Posted: April 29, 2011    Key Record Dates
Last Update Posted: August 23, 2012
Last Verified: August 2012

Additional relevant MeSH terms:
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Factor Xa Inhibitors
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action