Ignite Creation Date:
2025-12-24 @ 4:39 PM
Ignite Modification Date:
2025-12-30 @ 10:33 PM
Study NCT ID:
NCT00123266
Status:
TERMINATED
Last Update Posted:
2014-04-07
First Post:
2005-07-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intra-arterial Microplasmin Administration in Patients With Acute Intracranial Vertebrobasilar Artery Occlusion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C054561', 'term': 'microplasmin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'whyStopped': "Sponsor's decision not to pursue development of uPLi for vascular conditions.", 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-04', 'studyFirstSubmitDate': '2005-07-21', 'studyFirstSubmitQcDate': '2005-07-21', 'lastUpdatePostDateStruct': {'date': '2014-04-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-07-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recanalization rate', 'timeFrame': 'Day-7, Day-30 and Day-90'}], 'secondaryOutcomes': [{'measure': 'Clinical assessment', 'timeFrame': 'Day-7, Day-30 and Day-90'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['stroke', 'vertebrobasilar', 'basilar', 'Acute vertebrobasilar artery occlusion'], 'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': 'The purpose of the trial is to evaluate the safety of microplasmin as well as its ability to open blocked arteries to the brain in patients with acute stroke when given into the artery at the site of the blockage.', 'detailedDescription': 'Patients with angiographically documented acute intracranial vertebrobasilar artery occlusion presenting within 24 hours of neurological symptom onset will be enrolled into this open-label trial. During study drug administration, angiograms will be repeated at regular intervals to determine degree of clot lysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with angiographically documented vertebrobasilar artery occlusion\n2. Initiation of study drug treatment within 24 hours of the onset of neurological symptoms\n3. Age 18-75 (inclusive).\n\nExclusion Criteria:\n\n1. Patients with coma \\> 6 hrs duration and complete loss of brain stem reflexes (corneal reflex, gag reflex, VOR, pupil reflexes) as measured at the last assessment before sedation/intubation\n2. Rapidly improving neurologic signs at any time before initiation of study drug administration.\n3. Known contrast agent-sensitivity\n4. Uncontrolled hypertension defined as a systolic blood pressure \\> 180 mm Hg or a diastolic blood pressure \\> 100 mm Hg on 3 separate occasions at least 10 minutes apart or requiring continuous IV therapy.\n5. History of stroke within the previous 6 weeks.'}, 'identificationModule': {'nctId': 'NCT00123266', 'acronym': 'MITI-IA', 'briefTitle': 'Intra-arterial Microplasmin Administration in Patients With Acute Intracranial Vertebrobasilar Artery Occlusion', 'organization': {'class': 'INDUSTRY', 'fullName': 'ThromboGenics'}, 'officialTitle': 'An Open-label, Clinical Trial of Intra-arterial Microplasmin Administration in Patients With Acute Intracranial Vertebrobasilar Artery Occlusion', 'orgStudyIdInfo': {'id': 'TG-M-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active', 'interventionNames': ['Drug: Microplasmin']}], 'interventions': [{'name': 'Microplasmin', 'type': 'DRUG', 'description': '2 mg/kg, IA over 75 mins', 'armGroupLabels': ['Active']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'D-91054', 'city': 'Erlangen', 'country': 'Germany', 'facility': 'Universitätsklinikum Erlangen', 'geoPoint': {'lat': 49.59099, 'lon': 11.00783}}, {'zip': 'D-79106', 'city': 'Freiburg im Breisgau', 'country': 'Germany', 'facility': 'Universitatsklinikum Freiburg', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}, {'zip': '66421', 'city': 'Homburg/Saar', 'country': 'Germany', 'facility': 'Universitätsklinikum des Saarlandes'}, {'zip': '24105', 'city': 'Kiel', 'country': 'Germany', 'facility': 'UKSH Campus Kiel', 'geoPoint': {'lat': 54.32133, 'lon': 10.13489}}, {'city': 'Munich', 'country': 'Germany', 'facility': 'Ludwig-Maximilians-University Hospital', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}, {'zip': '65199', 'city': 'Wiesbaden', 'country': 'Germany', 'facility': 'HSK Dr. Horst Schmidt Hospital', 'geoPoint': {'lat': 50.08601, 'lon': 8.24435}}, {'zip': '3430 EM', 'city': 'Nieuwegein', 'country': 'Netherlands', 'facility': 'Sint Antonius Ziekenhuis', 'geoPoint': {'lat': 52.02917, 'lon': 5.08056}}], 'overallOfficials': [{'name': 'Gerhard Hamann, Prof. Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'HSK Dr. Horst Schmidt Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ThromboGenics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}