Single Intravenous Administration of TB-402 for the Prophylaxis of Venous Thromboembolic Events (VTE) After Total Knee Replacement Surgery
NCT ID: NCT00793234
Last Updated: 2014-04-07
Study Results
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Basic Information
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COMPLETED
PHASE2
316 participants
INTERVENTIONAL
2008-12-31
2010-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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1
0.3 mg/kg TB-402
TB-402
TB-402 administered as single bolus 18-24 post total knee replacement surgery.
2
0.6 mg/kg TB-402
TB-402
TB-402 administered as single bolus 18-24 post total knee replacement surgery.
3
1.2 mg/kg TB-402
TB-402
TB-402 administered as single bolus 18-24 post total knee replacement surgery.
4
Enoxaparin
Enoxaparin 40mg/day sc injection for at least 10 days post-surgery
Interventions
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TB-402
TB-402 administered as single bolus 18-24 post total knee replacement surgery.
Enoxaparin
Enoxaparin 40mg/day sc injection for at least 10 days post-surgery
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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BioInvent International AB
INDUSTRY
Covance
INDUSTRY
ThromboGenics
INDUSTRY
Responsible Party
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Locations
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SHAT of orthopedics, traumatology and surgery "Sv. Pantaleimon " - Pleven Department of Orthopaedics and Traumatology
Pleven, , Bulgaria
Dept. of Orthopedics, UMHAT "Saint George"
Plovdiv, , Bulgaria
MHAT Rousse
Rousse, , Bulgaria
MHAT "Sveta Anna" AD - Sofia, Clinic of Orthopedics and Traumatology
Sofia, , Bulgaria
MHAT "Sv. Anna", Department of Orthopaedics and Traumatology
Varna, , Bulgaria
Asaf Harofeh MC
Beer-Yaakov, , Israel
Soroka MC
Beersheba, , Israel
Rambam MC
Haifa, , Israel
Shaare Zedek MC
Jerusalem, , Israel
Meir Medical Center (MC)
Kfar Saba, , Israel
Beilinson Hospital
Petah Tikva, , Israel
Kaplan MC
Rehovot, , Israel
Sourasky MC
Tel Aviv, , Israel
Ltd "Liepajas regionala slimnica"
Liepāja, , Latvia
Ltd "Traumatologijas un ortopedijas slimnica"
Riga, , Latvia
Vidzemes slimnica
Valmiera, , Latvia
Szpital Uniwersytecki im. dr. Antoniego Jurasza w Bydgoszczy Klinika Ortopedii i Traumatologii Narządu Ruchu
Bydgoszcz, , Poland
Wojewódzki Szpital Specjalistyczny im. L. Rydygiera w Krakowie, Oddział Kliniczny Ortopedii i Traumatologii Narządu Ruchu
Krakow, , Poland
Uniwersytecki Szpital Kliniczny w Białymstoku, Klinika Ortopedii i Traumatologii
Podlaski, , Poland
Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie, Katedra i Klinika Ortopedii Traumatologii i Rehabilitacji
Trzemeszno Lubuskie, , Poland
Wojewódzki Szpital Bródnowski Samodzielny Publiczny Zakład Opieki Zdrowotnej, Oddział Chirurgii Urazowo-Ortopedycznej i Rehabilitacji
Warsaw, , Poland
Spitalul Clinic de Urgenta Sf. Ioan Bucuresti
Bucharest, , Romania
Spitalul Clinic de Urgenta Prof. Dr. Octavian Fodor CLUJ NAPOCA
Cluj-Napoca, , Romania
Spitalul Clinic Judetean de Urgenta Craiova
Craiova, , Romania
Municipal Healthcare Institution "City Clinical Hospital No. 3"
Chelyabinsk, , Russia
Moscow State Healthcare Institution "City Clinical Hospital No. 15 n.a. O.M. Filatov"
Moscow, , Russia
Municipal Healthcare Institution "City Clinical Hospital No. 4"
Orenburg, , Russia
Saint Petersburg State Healthcare Institution "Aleksandrovskaya Hospital"
Saint Petersburg, , Russia
Federal State Medical Institution: Clinical Hospital #122 named after L.G. Sokolov under the Federal Medical-Biological Agency
Saint Petersburg, , Russia
Saint Petersburg State Healthcare Institution "Municipal Multi-Speciality Hospital No. 2"
Saint Petersburg, , Russia
Federal State Institution "Russian Research Institute of Traumatology and Orthopedics n.a. R.R. Vreden under the Federal Authority for Healthcare and Social Development"
Saint Petersburg, , Russia
State Healthcare Institution "Samara Regional Clinical Hospital n.a. M.I. Kalinin"
Samara, , Russia
Cherkasska Regional Hospital. Department of Orthopedics and Traumatology.
Cherkassy, , Ukraine
Ivano-Frankіvsk Regional Clinical Hospital, Department of ortopedics and traumatology.
Ivano-Frankivsk, , Ukraine
Odessa Regional Clinical Hospital, Department of Orthopedics and Traumatology
Odesa, , Ukraine
Countries
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Other Identifiers
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TB-402-004
Identifier Type: -
Identifier Source: org_study_id
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