Ignite Creation Date:
2025-12-24 @ 5:38 PM
Ignite Modification Date:
2026-01-20 @ 5:59 AM
Study NCT ID:
NCT02093468
Status:
TERMINATED
Last Update Posted:
2015-12-15
First Post:
2014-03-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of MST-188 in Acute Lower Limb Ischemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}}, 'statusModule': {'whyStopped': 'Program discontinued to persue alternate indications.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'lastUpdateSubmitDate': '2015-12-11', 'studyFirstSubmitDate': '2014-03-18', 'studyFirstSubmitQcDate': '2014-03-20', 'lastUpdatePostDateStruct': {'date': '2015-12-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-03-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Angiographic assessment of the change in the volume of thrombus (Exploratory endpoint)', 'timeFrame': 'Baseline, 8 and 24 hours'}, {'measure': 'Assessment of the change in TcPO2 (Exploratory endpoint)', 'timeFrame': 'Baseline, 8, 12, and 24 hours'}, {'measure': 'Number of participants with adverse events', 'timeFrame': 'Randomization through 30 days post-treatment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Acute limb ischemia', 'ALI', 'Acute lower extremity arterial occlusion'], 'conditions': ['Acute Limb Ischemia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and efficacy of MST-188 in subjects receiving catheter-directed rt-PA for acute lower limb ischemia and to evaluate whether treatment with MST-188 results in more rapid thrombolysis of the occlusion and more rapid tissue perfusion in the effected blood vessel.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age ≥30 to \\<80\n* Symptoms consistent with ALI in target lower limb classified as Rutherford Category IIa or IIb\n* Subject is hospitalized or in the process of hospitalization for the treatment of ALI\n* Angiographic confirmation of thrombotic lower limb arterial occlusion\n\nExclusion Criteria:\n\n* Prosthetic bypass graft occlusion within 1 month of implantation or autogenous graft occlusion within 6 months of placement\n* Treatment with a thrombolytic agent within the last 48 hours\n* Subject's laboratory results indicate inadequate organ function\n* NYHA Class IV congestive heart failure\n* Prior major amputation of the target limb\n* Other complications or contraindications for receiving rt-PA, anticoagulants, or contrast media"}, 'identificationModule': {'nctId': 'NCT02093468', 'briefTitle': 'Evaluation of MST-188 in Acute Lower Limb Ischemia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Mast Therapeutics, Inc.'}, 'officialTitle': 'Evaluation of MST-188 in Acute Lower Limb Ischemia: A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Multi-Center Clinical Trial Evaluating the Safety and Efficacy of MST-188 in Subjects With Acute Lower Limb Ischemia Receiving Catheter-Directed Recombinant Tissue Plasminogen Activator', 'orgStudyIdInfo': {'id': 'MST-188-07'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Saline', 'description': 'Saline administered IV for 12 hours', 'interventionNames': ['Drug: Saline']}, {'type': 'EXPERIMENTAL', 'label': 'Lower Dose', 'description': 'MST-188 loading dose 100 mg/kg IV for 1 hour followed by 25 mg/kg/hr for 11 hours', 'interventionNames': ['Drug: MST-188']}, {'type': 'EXPERIMENTAL', 'label': 'Higher Dose', 'description': 'MST-188 loading dose 200 mg/kg IV for 1 hour followed by 75 mg/kg/hr for 11 hours', 'interventionNames': ['Drug: MST-188']}], 'interventions': [{'name': 'MST-188', 'type': 'DRUG', 'otherNames': ['vepoloxamer'], 'armGroupLabels': ['Higher Dose', 'Lower Dose']}, {'name': 'Saline', 'type': 'DRUG', 'armGroupLabels': ['Saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Research Center', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '33606', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Center', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '11219', 'city': 'Brooklyn', 'state': 'New York', 'country': 'United States', 'facility': 'Research Center', 'geoPoint': {'lat': 40.6501, 'lon': -73.94958}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Research Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Edwin L Parsley, D.O.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Mast Therapeutics, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mast Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}