Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2026-02-05 @ 5:46 PM
Study NCT ID:
NCT00793234
Status:
COMPLETED
Last Update Posted:
2014-04-07
First Post:
2008-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Single Intravenous Administration of TB-402 for the Prophylaxis of Venous Thromboembolic Events (VTE) After Total Knee Replacement Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C559990', 'term': 'TB 402'}, {'id': 'D017984', 'term': 'Enoxaparin'}], 'ancestors': [{'id': 'D006495', 'term': 'Heparin, Low-Molecular-Weight'}, {'id': 'D006493', 'term': 'Heparin'}, {'id': 'D006025', 'term': 'Glycosaminoglycans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 316}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-04', 'studyFirstSubmitDate': '2008-11-18', 'studyFirstSubmitQcDate': '2008-11-18', 'lastUpdatePostDateStruct': {'date': '2014-04-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-11-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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.', 'timeFrame': 'All visists from randomization to end of study'}, {'measure': 'Composite of the occurrence of asymptomatic DVT as detected by bilateral venography and symptomatic VTE, i.e. DVT or fatal or non-fatal PE.', 'timeFrame': 'Prior to hospital discharge Day 7-11'}], 'secondaryOutcomes': [{'measure': 'Incidence of major bleeding events', 'timeFrame': 'All visists from randomization to end of study'}, {'measure': 'Incidence of clinically significant non-major bleeding events', 'timeFrame': 'All visits from randomization to end of study'}, {'measure': 'Incidence of minor bleeding events', 'timeFrame': 'All visits from randomization to end of study'}, {'measure': 'Incidence of all cause mortality', 'timeFrame': 'All visits from randomization to end of study'}, {'measure': 'Incidence of adverse events', 'timeFrame': 'All visists from randomization to end of study'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['TKR', 'VTE', 'DVT'], 'conditions': ['Total Knee Replacement Surgery']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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).\n\nImproved 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).\n\nIn 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female patients aged \\> 18 and \\< 80 years old\n* Female patients should be post menopausal\n* Patients undergoing primary elective total knee replacement surgery\n* Written informed consent obtained from the patient (or a legally acceptable representative) prior to inclusion in the study\n* Willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures\n\nExclusion Criteria:\n\n* Body weight \\< 50 kg or \\> 100 kg\n* Patients undergoing a hemiarthroplasty, surface repair or revisionary surgery of the knee\n* Confirmed symptomatic deep vein thrombosis or pulmonary embolism within the past year\n* Anticipated use of indwelling intrathecal or epidural catheter for more than 4 h after surgery or during the entire study\n* Uncontrolled hypertension (SBP\\>160 mm Hg or DBP \\> 100 mm Hg)\n* History of intracranial or intraocular bleeding. History of gastrointestinal and/or endoscopically verified ulcer disease within the past year'}, 'identificationModule': {'nctId': 'NCT00793234', 'briefTitle': 'Single Intravenous Administration of TB-402 for the Prophylaxis of Venous Thromboembolic Events (VTE) After Total Knee Replacement Surgery', 'organization': {'class': 'INDUSTRY', 'fullName': 'ThromboGenics'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'TB-402-004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': '0.3 mg/kg TB-402', 'interventionNames': ['Drug: TB-402']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': '0.6 mg/kg TB-402', 'interventionNames': ['Drug: TB-402']}, {'type': 'EXPERIMENTAL', 'label': '3', 'description': '1.2 mg/kg TB-402', 'interventionNames': ['Drug: TB-402']}, {'type': 'ACTIVE_COMPARATOR', 'label': '4', 'interventionNames': ['Drug: Enoxaparin']}], 'interventions': [{'name': 'TB-402', 'type': 'DRUG', 'description': 'TB-402 administered as single bolus 18-24 post total knee replacement surgery.', 'armGroupLabels': ['1', '2', '3']}, {'name': 'Enoxaparin', 'type': 'DRUG', 'description': 'Enoxaparin 40mg/day sc injection for at least 10 days post-surgery', 'armGroupLabels': ['4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5800', 'city': 'Pleven', 'country': 'Bulgaria', 'facility': 'SHAT of orthopedics, traumatology and surgery "Sv. Pantaleimon " - Pleven Department of Orthopaedics and Traumatology', 'geoPoint': {'lat': 43.41791, 'lon': 24.61666}}, {'zip': '4002', 'city': 'Plovdiv', 'country': 'Bulgaria', 'facility': 'Dept. of Orthopedics, UMHAT "Saint George"', 'geoPoint': {'lat': 42.15387, 'lon': 24.75001}}, {'zip': '7002', 'city': 'Rousse', 'country': 'Bulgaria', 'facility': 'MHAT Rousse', 'geoPoint': {'lat': 43.84872, 'lon': 25.9534}}, {'zip': '1709', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'MHAT "Sveta Anna" AD - Sofia, Clinic of Orthopedics and Traumatology', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '9000', 'city': 'Varna', 'country': 'Bulgaria', 'facility': 'MHAT "Sv. Anna", Department of Orthopaedics and Traumatology', 'geoPoint': {'lat': 43.21912, 'lon': 27.91024}}, {'zip': '70300', 'city': 'Beer-Yaakov', 'country': 'Israel', 'facility': 'Asaf Harofeh MC'}, {'zip': '84101', 'city': 'Beersheba', 'country': 'Israel', 'facility': 'Soroka MC', 'geoPoint': {'lat': 31.25181, 'lon': 34.7913}}, {'zip': '31096', 'city': 'Haifa', 'country': 'Israel', 'facility': 'Rambam MC', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}, {'zip': '91031', 'city': 'Jerusalem', 'country': 'Israel', 'facility': 'Shaare Zedek MC', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}, {'zip': '44281', 'city': 'Kfar Saba', 'country': 'Israel', 'facility': 'Meir Medical Center (MC)', 'geoPoint': {'lat': 32.175, 'lon': 34.90694}}, {'zip': '49100', 'city': 'Petah Tikva', 'country': 'Israel', 'facility': 'Beilinson Hospital', 'geoPoint': {'lat': 32.08707, 'lon': 34.88747}}, {'zip': '76100', 'city': 'Rehovot', 'country': 'Israel', 'facility': 'Kaplan MC', 'geoPoint': {'lat': 31.89421, 'lon': 34.81199}}, {'zip': '64239', 'city': 'Tel Aviv', 'country': 'Israel', 'facility': 'Sourasky MC', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}, {'zip': 'LV-3400', 'city': 'Liepāja', 'country': 'Latvia', 'facility': 'Ltd "Liepajas regionala slimnica"', 'geoPoint': {'lat': 56.50474, 'lon': 21.01085}}, {'zip': 'LV-1005', 'city': 'Riga', 'country': 'Latvia', 'facility': 'Ltd "Traumatologijas un ortopedijas slimnica"', 'geoPoint': {'lat': 56.946, 'lon': 24.10589}}, {'zip': 'LV 4201', 'city': 'Valmiera', 'country': 'Latvia', 'facility': 'Vidzemes slimnica', 'geoPoint': {'lat': 57.54108, 'lon': 25.42751}}, {'zip': '85-094', 'city': 'Bydgoszcz', 'country': 'Poland', 'facility': 'Szpital Uniwersytecki im. dr. Antoniego Jurasza w Bydgoszczy Klinika Ortopedii i Traumatologii Narządu Ruchu', 'geoPoint': {'lat': 53.1235, 'lon': 18.00762}}, {'zip': '31-826', 'city': 'Krakow', 'country': 'Poland', 'facility': 'Wojewódzki Szpital Specjalistyczny im. L. Rydygiera w Krakowie, Oddział Kliniczny Ortopedii i Traumatologii Narządu Ruchu', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '15-276', 'city': 'Podlaski', 'country': 'Poland', 'facility': 'Uniwersytecki Szpital Kliniczny w Białymstoku, Klinika Ortopedii i Traumatologii', 'geoPoint': {'lat': 53.09312, 'lon': 17.80653}}, {'zip': '20-090', 'city': 'Trzemeszno Lubuskie', 'country': 'Poland', 'facility': 'Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie, Katedra i Klinika Ortopedii Traumatologii i Rehabilitacji', 'geoPoint': {'lat': 52.4355, 'lon': 15.25572}}, {'zip': '03-242', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Wojewódzki Szpital Bródnowski Samodzielny Publiczny Zakład Opieki Zdrowotnej, Oddział Chirurgii Urazowo-Ortopedycznej i Rehabilitacji', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '042122', 'city': 'Bucharest', 'country': 'Romania', 'facility': 'Spitalul Clinic de Urgenta Sf. Ioan Bucuresti', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'zip': '400132', 'city': 'Cluj-Napoca', 'country': 'Romania', 'facility': 'Spitalul Clinic de Urgenta Prof. Dr. Octavian Fodor CLUJ NAPOCA', 'geoPoint': {'lat': 46.76667, 'lon': 23.6}}, {'zip': '200642', 'city': 'Craiova', 'country': 'Romania', 'facility': 'Spitalul Clinic Judetean de Urgenta Craiova', 'geoPoint': {'lat': 44.31667, 'lon': 23.8}}, {'zip': '454136', 'city': 'Chelyabinsk', 'country': 'Russia', 'facility': 'Municipal Healthcare Institution "City Clinical Hospital No. 3"', 'geoPoint': {'lat': 55.1611, 'lon': 61.42877}}, {'zip': '111539', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Moscow State Healthcare Institution "City Clinical Hospital No. 15 n.a. O.M. Filatov"', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '460000', 'city': 'Orenburg', 'country': 'Russia', 'facility': 'Municipal Healthcare Institution "City Clinical Hospital No. 4"', 'geoPoint': {'lat': 51.76712, 'lon': 55.09883}}, {'zip': '193312', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Saint Petersburg State Healthcare Institution "Aleksandrovskaya Hospital"', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '194291', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Federal State Medical Institution: Clinical Hospital #122 named after L.G. Sokolov under the Federal Medical-Biological Agency', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '194354', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Saint Petersburg State Healthcare Institution "Municipal Multi-Speciality Hospital No. 2"', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '197046', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Federal State Institution "Russian Research Institute of Traumatology and Orthopedics n.a. R.R. Vreden under the Federal Authority for Healthcare and Social Development"', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '443095', 'city': 'Samara', 'country': 'Russia', 'facility': 'State Healthcare Institution "Samara Regional Clinical Hospital n.a. M.I. Kalinin"', 'geoPoint': {'lat': 53.20767, 'lon': 50.13553}}, {'zip': '18009', 'city': 'Cherkassy', 'country': 'Ukraine', 'facility': 'Cherkasska Regional Hospital. Department of Orthopedics and Traumatology.', 'geoPoint': {'lat': 49.44452, 'lon': 32.05738}}, {'zip': '76008', 'city': 'Ivano-Frankivsk', 'country': 'Ukraine', 'facility': 'Ivano-Frankіvsk Regional Clinical Hospital, Department of ortopedics and traumatology.', 'geoPoint': {'lat': 48.92312, 'lon': 24.71248}}, {'zip': '65025', 'city': 'Odesa', 'country': 'Ukraine', 'facility': 'Odessa Regional Clinical Hospital, Department of Orthopedics and Traumatology', 'geoPoint': {'lat': 46.48572, 'lon': 30.74383}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ThromboGenics', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'BioInvent International AB', 'class': 'INDUSTRY'}, {'name': 'Covance', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}