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

This study has been completed.
Sponsor:
Collaborator:
BioInvent International AB
Information provided by (Responsible Party):
ThromboGenics
ClinicalTrials.gov Identifier:
NCT01344954
First received: March 18, 2011
Last updated: August 22, 2012
Last verified: August 2012
  Purpose

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 Intervention Phase
Prophylaxis of Venous Thromboembolic Events
Drug: TB-402
Drug: Rivaroxaban
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by ThromboGenics:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidents of major VTE [ Time Frame: Randomisation to Post-Operative day 35 ] [ Designated as safety issue: No ]
  • Incidents of total DVT [ Time Frame: Randomisation to Post-Operative day 35 ] [ Designated as safety issue: No ]
  • Incidents of proximal/distal DVT [ Time Frame: Randomisation to Post-Operative day 35 ] [ Designated as safety issue: No ]
  • Incidents of pulmonary embolism [ Time Frame: Randomisation to Post-Operative day 35 ] [ Designated as safety issue: No ]
  • Incidents of VTE-related death [ Time Frame: Randomisation to Post-Operative day 35 ] [ Designated as safety issue: No ]
  • Incidents of Major VTE [ Time Frame: Randomisation to Post-Operative day 70 ] [ Designated as safety issue: No ]

Enrollment: 632
Study Start Date: April 2011
Study Completion Date: May 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01344954

  Show 36 Study Locations
Sponsors and Collaborators
ThromboGenics
BioInvent International AB
  More Information

No publications provided

Responsible Party: ThromboGenics
ClinicalTrials.gov Identifier: NCT01344954     History of Changes
Other Study ID Numbers: TB-402-006
Study First Received: March 18, 2011
Last Updated: August 22, 2012
Health Authority: Austria: Agency for Health and Food Safety
Belgium: Federal Agency for Medicinal Products and Health Products
Bulgaria: Bulgarian Drug Agency
Hungary: National Institute of Pharmacy
Latvia: State Agency of Medicines
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Russia: Ministry of Health of the Russian Federation
Ukraine: Ministry of Health

Additional relevant MeSH terms:
Thromboembolism
Embolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Thrombosis

ClinicalTrials.gov processed this record on July 20, 2014