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Single Intravenous Administration of TB-402 for the Prophylaxis of Venous Thromboembolic Events (VTE) After Total Knee Replacement Surgery

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ClinicalTrials.gov Identifier: NCT00793234
Recruitment Status : Completed
First Posted : November 19, 2008
Last Update Posted : April 7, 2014
Sponsor:
Collaborators:
BioInvent International AB
Covance
Information provided by (Responsible Party):
ThromboGenics

Tracking Information
First Submitted Date  ICMJE November 18, 2008
First Posted Date  ICMJE November 19, 2008
Last Update Posted Date April 7, 2014
Study Start Date  ICMJE December 2008
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 18, 2008)
  • The occurrence of total bleeding defined as major and/or clinically relevant non-major bleeding events, from randomisation until the end of the study. [ Time Frame: All visists from randomization to end of study ]
  • Composite of the occurrence of asymptomatic DVT as detected by bilateral venography and symptomatic VTE, i.e. DVT or fatal or non-fatal PE. [ Time Frame: Prior to hospital discharge Day 7-11 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 18, 2008)
  • Incidence of major bleeding events [ Time Frame: All visists from randomization to end of study ]
  • Incidence of clinically significant non-major bleeding events [ Time Frame: All visits from randomization to end of study ]
  • Incidence of minor bleeding events [ Time Frame: All visits from randomization to end of study ]
  • Incidence of all cause mortality [ Time Frame: All visits from randomization to end of study ]
  • Incidence of adverse events [ Time Frame: All visists from randomization to end of study ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Single Intravenous Administration of TB-402 for the Prophylaxis of Venous Thromboembolic Events (VTE) After Total Knee Replacement Surgery
Official Title  ICMJE Single Intravenous Administration of TB-402 for the Prophylaxis of Venous Thromboembolic Events (VTE) After Total Knee Replacement Surgery: A Dose-Escalating, Multicenter, Randomised, Active- Controlled Open Label Study
Brief Summary The purpose of this study is to evaluate the safety and efficacy of a single administration of TB-402 for the prevention of VTE in patients undergoing knee replacement surgery.
Detailed Description

Currently available anticoagulant therapies for the prevention of VTE include low molecular weight heparins, pentasaccharides and vitamin K antagonists, all of which have inherent limitations(1-3).

Improved anticoagulant agents are therefore required(4). A novel antithrombotic agent requires demonstration of both efficacy and safety in relevant populations. Phase II studies are frequently performed in patients undergoing total hip replacement and/or total knee replacement because of the high and well documented incidence of deep vein thrombosis in the absence of adequate thromboprophylaxis(5-7).

In this study, we assess the safety and efficacy of TB-402, a novel antithrombotic agent that partially inhibits factor VIII, in the prevention of VTE in patients undergoing total knee replacement surgery.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Total Knee Replacement Surgery
Intervention  ICMJE
  • Drug: TB-402
    TB-402 administered as single bolus 18-24 post total knee replacement surgery.
  • Drug: Enoxaparin
    Enoxaparin 40mg/day sc injection for at least 10 days post-surgery
Study Arms  ICMJE
  • Experimental: 1
    0.3 mg/kg TB-402
    Intervention: Drug: TB-402
  • Experimental: 2
    0.6 mg/kg TB-402
    Intervention: Drug: TB-402
  • Experimental: 3
    1.2 mg/kg TB-402
    Intervention: Drug: TB-402
  • Active Comparator: 4
    Intervention: Drug: Enoxaparin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 8, 2011)
316
Original Estimated Enrollment  ICMJE
 (submitted: November 18, 2008)
300
Actual Study Completion Date  ICMJE March 2010
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female patients aged > 18 and < 80 years old
  • Female patients should be post menopausal
  • Patients undergoing primary elective total knee replacement surgery
  • Written informed consent obtained from the patient (or a legally acceptable representative) prior to inclusion in the study
  • Willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures

Exclusion Criteria:

  • Body weight < 50 kg or > 100 kg
  • Patients undergoing a hemiarthroplasty, surface repair or revisionary surgery of the knee
  • Confirmed symptomatic deep vein thrombosis or pulmonary embolism within the past year
  • Anticipated use of indwelling intrathecal or epidural catheter for more than 4 h after surgery or during the entire study
  • Uncontrolled hypertension (SBP>160 mm Hg or DBP > 100 mm Hg)
  • History of intracranial or intraocular bleeding. History of gastrointestinal and/or endoscopically verified ulcer disease within the past year
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Bulgaria,   Israel,   Latvia,   Poland,   Romania,   Russian Federation,   Ukraine
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00793234
Other Study ID Numbers  ICMJE TB-402-004
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party ThromboGenics
Study Sponsor  ICMJE ThromboGenics
Collaborators  ICMJE
  • BioInvent International AB
  • Covance
Investigators  ICMJE Not Provided
PRS Account ThromboGenics
Verification Date April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP