Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2026-01-09 @ 12:20 PM
Study NCT ID:
NCT03088358
Status:
COMPLETED
Last Update Posted:
2017-03-23
First Post:
2017-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of TeaRx Xa Factor Direct Inhibitor Versus Enoxaparin as a Venous Thromboembolic Events (VTE) Prevention Following Total Knee Replacement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-18', 'studyFirstSubmitDate': '2017-02-26', 'studyFirstSubmitQcDate': '2017-03-18', 'lastUpdatePostDateStruct': {'date': '2017-03-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of deep venous thrombosis (DVT) (efficacy of the selected TeaRx dose)', 'timeFrame': '6 weeks following total knee replacement'}, {'measure': 'Incidence of nonfatal pulmonary embolism (PE) (efficacy of the selected TeaRx dose)', 'timeFrame': '6 weeks following total knee replacement'}, {'measure': 'Incidence of symptomatic venous thromboembolic events (DVT, PE) (efficacy of the selected TeaRx dose)', 'timeFrame': '6 weeks following total knee replacement'}, {'measure': 'venous thromboembolic events (VTE) caused mortality (efficacy of the selected TeaRx dose)', 'timeFrame': '6 weeks following total knee replacement'}, {'measure': 'Non-VTE caused mortality (efficacy of the selected TeaRx dose)', 'timeFrame': '6 weeks following total knee replacement'}, {'measure': 'AEs and SAEs from subject complaints, physical examination, vital signs, laboratory results (efficacy of the selected TeaRx dose)', 'timeFrame': '6 weeks following total knee replacement'}], 'secondaryOutcomes': [{'measure': 'Incidence of bleeding (safety of selected TeaRx dose)', 'timeFrame': '6 weeks following total knee replacement', 'description': 'major and clinically relevant non-major bleeding'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Total Knee Replacement']}, 'descriptionModule': {'briefSummary': 'To evaluate influence of therapy on the following efficacy and safety parameters in different TeaRx dose groups and Enoxaparin group:\n\n* Total venous thromboembolic events (VTE), which includes confirmed deep venous thrombosis (DVT), nonfatal pulmonary embolism (PE), and total mortality\n* Incidence of DVT (total, proximal, distal)\n* Incidence of nonfatal PE\n* Incidence of symptomatic VTE (DVT, PE)\n* VTE caused mortality\n* Non-VTE caused mortality\n* Incidence of all hemorrhagic complications\n* Incidence of major and clinically relevant non-major bleeding\n* Adverse events (AEs) and serious adverse events (SAEs) from subject complaints, physical examination, vital signs, laboratory results'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female, age ≥ 18 years;\n* Planned total knee replacement surgery;\n* Signed informed consent form;\n* Willing to comply with the protocol;\n* Willing to use adequate contraception during the trial.\n\nExclusion Criteria:\n\n* Surgery for acute fracture 4 weeks before screening; history of septic inflammation in the joint; prosthesis revision or one leg missing\n* History of venous thrombosis of any location or PE\n* History of heparin induced thrombocytopenia or other thrombocytopathy; hemorrhagic diathesis\n* History of evident coagulopathy or in a relative\n* Congenital thrombophilia\n* Bleeding within 6 months of screening; increased risk of bleeding\n* BMI less than 18,5 or more than 40 kg/m2\n* Systolic BP \\> 180 mmHg and/or diastolic BP \\> 110 mmHg registered twice within 15-30 minutes\n* Hb ≤ 10.5 g/dL in female or ≤ 11.5 g/dL in male\n* Platelets \\< 100 000/mm3\n* Clinical significant abnormalities of APTT and/or INR\n* GFR \\< 30 ml/min/1.73 m2\n* ALT or AST ≥ 2 x ULN or total bilirubin ≥1,5 x ULN'}, 'identificationModule': {'nctId': 'NCT03088358', 'briefTitle': 'Safety and Efficacy of TeaRx Xa Factor Direct Inhibitor Versus Enoxaparin as a Venous Thromboembolic Events (VTE) Prevention Following Total Knee Replacement', 'organization': {'class': 'INDUSTRY', 'fullName': 'TeaRx LLC'}, 'officialTitle': 'A Multicenter, Randomized, Pilot, Dose-Ranging Clinical Study to Evaluate Safety and Efficacy of TeaRx Xa Factor Direct Inhibitor Versus Enoxaparin as a Venous Thromboembolic Events (VTE) Prevention Following Total Knee Replacement', 'orgStudyIdInfo': {'id': 'CV-TRX-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TeaRx 50 mg', 'description': 'TeaRx: 50 mg per day PO (active 25 mg + placebo 50 mg every 12 hours) during 12 days (±2 days)', 'interventionNames': ['Drug: TeaRx']}, {'type': 'EXPERIMENTAL', 'label': 'TeaRx 100 mg', 'description': 'TeaRx: 100 mg per day PO (placebo 25 mg + active 50 mg every 12 hours) during 12 days (±2 days)', 'interventionNames': ['Drug: TeaRx']}, {'type': 'EXPERIMENTAL', 'label': 'TeaRx 150 mg', 'description': 'TeaRx: 150 mg per day PO (active 25 mg + active 50 mg every 12 hours) during 12 days (±2 days)', 'interventionNames': ['Drug: TeaRx']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Enoxaparin', 'description': 'Enoxaparin 40 mg subcutaneous per day (24 hours interval) during 12 days (±2 days)', 'interventionNames': ['Drug: Enoxaparin']}], 'interventions': [{'name': 'TeaRx', 'type': 'DRUG', 'otherNames': ['TeaRxaban'], 'armGroupLabels': ['TeaRx 100 mg', 'TeaRx 150 mg', 'TeaRx 50 mg']}, {'name': 'Enoxaparin', 'type': 'DRUG', 'otherNames': ['Clexane ®'], 'armGroupLabels': ['Enoxaparin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '420064', 'city': "Kazan'", 'country': 'Russia', 'facility': 'SHAI "Republican Clinical Hospital of the Ministry of Health of the Republic of Tatarstan"', 'geoPoint': {'lat': 55.78874, 'lon': 49.12214}}, {'zip': '105203', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Federal State Institution "National Medical and Surgical Center n. a. N. I. Pirogov" of the Ministry of Health of the Russian Federation', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '119435', 'city': 'Moscow', 'country': 'Russia', 'facility': 'SBEI HPE First Moscow State Medical University n.a. I.M. Sechenov Ministry of Health of the Russian Federation', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '125284', 'city': 'Moscow', 'country': 'Russia', 'facility': 'SHI of the city of Moscow City Clinical Hospital n.a. S.P. Botkin', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '603155', 'city': 'Nizhny Novgorod', 'country': 'Russia', 'facility': 'FSBI "Nizhny Novgorod Research Institute of Traumatology and Orthopedics" of the Ministry of Health of the Russian Federation', 'geoPoint': {'lat': 56.32867, 'lon': 44.00205}}, {'zip': '460000', 'city': 'Orenburg', 'country': 'Russia', 'facility': 'SBHI "City Clinical Hospital № 4" of the city of Orenburg', 'geoPoint': {'lat': 51.76712, 'lon': 55.09883}}, {'zip': '194354', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'St. Petersburg State Institution of Health "City Hospital № 2"', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '150003', 'city': 'Yaroslavl', 'country': 'Russia', 'facility': 'SHI of the Yaroslavl Region Emergency care hospital n. a. N. V. Solovyov', 'geoPoint': {'lat': 57.62987, 'lon': 39.87368}}], 'overallOfficials': [{'name': 'Mikhail N. Zamyatin, Prof.', 'role': 'STUDY_CHAIR', 'affiliation': 'Federal State Institution "National Medical and Surgical Center n. a. N. I. Pirogov" of the Ministry of Health of the Russian Federation'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TeaRx LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}