Ignite Creation Date:
2025-12-24 @ 11:50 AM
Ignite Modification Date:
2025-12-25 @ 11:53 AM
Study NCT ID:
NCT01713361
Status:
COMPLETED
Last Update Posted:
2014-08-27
First Post:
2012-10-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Active Comparator-Controlled Study to Assess Safety and Efficacy of ISIS-FXIRx in Total Knee Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054556', 'term': 'Venous Thromboembolism'}], 'ancestors': [{'id': 'D013923', 'term': 'Thromboembolism'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, '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': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 315}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-25', 'studyFirstSubmitDate': '2012-10-04', 'studyFirstSubmitQcDate': '2012-10-23', 'lastUpdatePostDateStruct': {'date': '2014-08-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-10-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary efficacy outcome', 'timeFrame': 'up to 12 days post-surgery', 'description': 'Composite of asymptomatic DVT (via bilateral venography), and symptomatic VTE, fatal PE, and unexplained death.'}], 'secondaryOutcomes': [{'measure': 'Secondary efficacy outcome', 'timeFrame': '1st dose to up to Day 76', 'description': 'All DVTs and PEs up to 4 weeks after bilateral venography'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['total knee arthroplasty', 'Prophylaxis'], 'conditions': ['Venous Thromboembolism']}, 'referencesModule': {'references': [{'pmid': '25482425', 'type': 'DERIVED', 'citation': 'Buller HR, Bethune C, Bhanot S, Gailani D, Monia BP, Raskob GE, Segers A, Verhamme P, Weitz JI; FXI-ASO TKA Investigators. Factor XI antisense oligonucleotide for prevention of venous thrombosis. N Engl J Med. 2015 Jan 15;372(3):232-40. doi: 10.1056/NEJMoa1405760. Epub 2014 Dec 7.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is:\n\n* To assess the safety and efficacy profile of ISIS-FXIRx, including incidence of bleeding and VTE, in patients undergoing total knee arthroplasty.\n* To compare the efficacy and safety profile of ISIS-FXIRx in patients who achieve less than or equal to 0.2 U/mL FXI activity levels to that of enoxaparin.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Give written informed consent\n* Females must be non-pregnant and non-lactating, and either surgically sterile or post-menopausal. Males must be surgically sterile, abstinent, or if engaged in sexual relations of child-bearing potential, must use contraception\n* Undergoing elective, primary unilateral total knee arthroplasty\n\nExclusion Criteria:\n\n* Body weight \\<50 kg\n* Patients at increased risk of bleeding. History of intracranial or intraocular bleeding. History of gastrointestinal and/or endoscopically verified ulcer disease within the past year.\n* History of excessive intra- or direct post operative bleeding or a traumatic spinal or epidural anesthesia\n* Brain, spinal, or ophthalmologic surgery within the past 3 months\n* History of clinically significant liver disease in the past year\n* Screening laboratory results as follows, or any other clinically significant abnormalities in screening laboratory values\n\n * aPTT or PT or INR \\>ULN\n * Factor IX activity \\<LLN\n * Factor VIII activity, vWF antigen or Ristocetin cofactor activity \\<0.5 U/mL\n * FXI activity \\<0.3 U/mL\n * Urine protein or blood persistently positive by dipstick. In the event of positive test results, eligibility may be confirmed with urine microscopy or 24 hour urine protein measurement as applicable\n * ALT or AST \\>1.5 x ULN\n * Total bilirubin \\>ULN\n * Platelet count \\<150,000 (or history of thrombocytopenia)\n* Hypersensitivity to enoxaparin\n* Anticipated concomitant use of anticoagulants/antiplatelet agents or the NSAID nimesulide that may affect study outcome or any other drug influencing coagulation (except low dose aspirin and short acting NSAIDs with a half-life \\<20 hours) at least 7 days before surgery or during treatment with ISIS Rx.\n* Anticipated use of indwelling intrathecal or epidural catheters\n* Anemia at Screening\n* Have any other conditions which could interfere with the patient participating in or completing the study'}, 'identificationModule': {'nctId': 'NCT01713361', 'briefTitle': 'Active Comparator-Controlled Study to Assess Safety and Efficacy of ISIS-FXIRx in Total Knee Arthroplasty', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ionis Pharmaceuticals, Inc.'}, 'officialTitle': 'An Open-label, Randomized, Active Comparator-Controlled, Adaptive Parallel-group Phase 2 Study to Assess the Safety and Efficacy of Multiple Doses of ISIS 416858 Administered Subcutaneously to Patients Undergoing Total Knee Arthroplasty', 'orgStudyIdInfo': {'id': 'ISIS 416858-CS3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ISIS-FXIRx Dose 2', 'description': 'Group B: ISIS-FXIRx Dose #2', 'interventionNames': ['Drug: ISIS-FXIRx Dose #2']}, {'type': 'EXPERIMENTAL', 'label': 'ISIS-FXIRx Dose 3', 'description': 'Group C: ISIS-FXIRx Dose #3', 'interventionNames': ['Drug: ISIS-FXIRx Dose #3']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Enoxaparin', 'description': 'Enoxaparin (40mg)', 'interventionNames': ['Drug: Enoxaparin']}], 'interventions': [{'name': 'ISIS-FXIRx Dose #2', 'type': 'DRUG', 'otherNames': ['ISIS-FXIRx'], 'description': 'Group B: ISIS-FXIRx dose #2 subcutaneously administered 7 times prior to total knee arthroplasty, and 2 times after surgery.', 'armGroupLabels': ['ISIS-FXIRx Dose 2']}, {'name': 'ISIS-FXIRx Dose #3', 'type': 'DRUG', 'otherNames': ['ISIS-FXIRx'], 'description': 'Group C: ISIS-FXIRx dose #3 subcutaneously administered 7 times prior to total knee arthroplasty, and 2 times after surgery.', 'armGroupLabels': ['ISIS-FXIRx Dose 3']}, {'name': 'Enoxaparin', 'type': 'DRUG', 'otherNames': ['Lovenox', 'Clexane'], 'description': 'Enoxaparin (40mg) will be administered by subcutaneous injection the evening prior to total knee arthroplasty (optionally), 6 to 8 hours after surgery, followed by daily injections for at least 8 additional days post surgery (a total of at least 9 consecutive days). \\[Except for Canadian region, in which the subcutaneous injection of enoxaparin the evening prior to total knee arthroplasty is expected, resulting in a total of at least 10 consecutive days of enoxaparin.\\]', 'armGroupLabels': ['Enoxaparin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4002', 'city': 'Plovdiv', 'country': 'Bulgaria', 'facility': 'Isis Investigational Site', 'geoPoint': {'lat': 42.15387, 'lon': 24.75001}}, {'zip': '7002', 'city': 'Rousse', 'country': 'Bulgaria', 'facility': 'Isis Investigational Site', 'geoPoint': {'lat': 43.84872, 'lon': 25.9534}}, {'zip': '1527', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'Isis Investigational Site', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': 'LIS 2J4', 'city': 'Ajax', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Isis Investigational Site', 'geoPoint': {'lat': 43.85012, 'lon': -79.03288}}, {'zip': 'LIG 2B9', 'city': 'Oshawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Isis Investigational Site', 'geoPoint': {'lat': 43.90012, 'lon': -78.84957}}, {'zip': 'LV 2164', 'city': 'Ādaži', 'country': 'Latvia', 'facility': 'Isis Investigational Site', 'geoPoint': {'lat': 57.0708, 'lon': 24.33678}}, {'zip': 'LV 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'Ukraine', 'facility': 'Isis Investigational Site', 'geoPoint': {'lat': 46.48572, 'lon': 30.74383}}, {'zip': '99018', 'city': 'Sevastopol', 'country': 'Ukraine', 'facility': 'Isis Investigational Site', 'geoPoint': {'lat': 44.60795, 'lon': 33.52134}}], 'overallOfficials': [{'name': 'Sanjay Bhanot, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'VP, Clinical Development, Isis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ionis Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}