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

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.

Condition or disease Intervention/treatment Phase
Total Knee Replacement Surgery Drug: TB-402 Drug: Enoxaparin Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 316 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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
Study Start Date : December 2008
Actual Primary Completion Date : January 2010
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arm Intervention/treatment
Experimental: 1
0.3 mg/kg TB-402
Drug: TB-402
TB-402 administered as single bolus 18-24 post total knee replacement surgery.

Experimental: 2
0.6 mg/kg TB-402
Drug: TB-402
TB-402 administered as single bolus 18-24 post total knee replacement surgery.

Experimental: 3
1.2 mg/kg TB-402
Drug: TB-402
TB-402 administered as single bolus 18-24 post total knee replacement surgery.

Active Comparator: 4 Drug: Enoxaparin
Enoxaparin 40mg/day sc injection for at least 10 days post-surgery




Primary Outcome Measures :
  1. 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 ]
  2. 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 ]

Secondary Outcome Measures :
  1. Incidence of major bleeding events [ Time Frame: All visists from randomization to end of study ]
  2. Incidence of clinically significant non-major bleeding events [ Time Frame: All visits from randomization to end of study ]
  3. Incidence of minor bleeding events [ Time Frame: All visits from randomization to end of study ]
  4. Incidence of all cause mortality [ Time Frame: All visits from randomization to end of study ]
  5. Incidence of adverse events [ Time Frame: All visists from randomization to end of study ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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 ClinicalTrials.gov identifier (NCT number): NCT00793234


Locations
Show Show 35 study locations
Sponsors and Collaborators
ThromboGenics
BioInvent International AB
Covance
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Responsible Party: ThromboGenics
ClinicalTrials.gov Identifier: NCT00793234    
Other Study ID Numbers: TB-402-004
First Posted: November 19, 2008    Key Record Dates
Last Update Posted: April 7, 2014
Last Verified: April 2014
Keywords provided by ThromboGenics:
TKR
VTE
DVT
Additional relevant MeSH terms:
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Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Enoxaparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action