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

This study has been completed.
Sponsor:
Collaborators:
BioInvent International AB
Covance
Information provided by (Responsible Party):
ThromboGenics
ClinicalTrials.gov Identifier:
NCT00793234
First received: November 18, 2008
Last updated: April 4, 2014
Last verified: April 2014

November 18, 2008
April 4, 2014
December 2008
January 2010   (final data collection date for primary outcome measure)
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00793234 on ClinicalTrials.gov Archive Site
  • Incidence of major bleeding events [ Time Frame: All visists from randomization to end of study ] [ Designated as safety issue: Yes ]
  • Incidence of clinically significant non-major bleeding events [ Time Frame: All visits from randomization to end of study ] [ Designated as safety issue: Yes ]
  • Incidence of minor bleeding events [ Time Frame: All visits from randomization to end of study ] [ Designated as safety issue: Yes ]
  • Incidence of all cause mortality [ Time Frame: All visits from randomization to end of study ] [ Designated as safety issue: Yes ]
  • Incidence of adverse events [ Time Frame: All visists from randomization to end of study ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Single Intravenous Administration of TB-402 for the Prophylaxis of Venous Thromboembolic Events (VTE) After Total Knee Replacement Surgery
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

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Total Knee Replacement Surgery
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
316
March 2010
January 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Bulgaria,   Israel,   Latvia,   Poland,   Romania,   Russian Federation,   Ukraine
 
NCT00793234
TB-402-004
Yes
ThromboGenics
ThromboGenics
  • BioInvent International AB
  • Covance
Not Provided
ThromboGenics
April 2014

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