Ignite Creation Date:
2025-12-24 @ 1:58 PM
Ignite Modification Date:
2025-12-31 @ 11:01 PM
Study NCT ID:
NCT01452295
Status:
WITHDRAWN
Last Update Posted:
2013-12-04
First Post:
2011-10-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Registry Protocol for Tracking Trial Subjects After VTI-206 Study Completion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017114', 'term': 'Liver Failure, Acute'}, {'id': 'D017093', 'term': 'Liver Failure'}, {'id': 'D006519', 'term': 'Hepatitis, Alcoholic'}], 'ancestors': [{'id': 'D048550', 'term': 'Hepatic Insufficiency'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008108', 'term': 'Liver Diseases, Alcoholic'}, {'id': 'D020751', 'term': 'Alcohol-Induced Disorders'}, {'id': 'D019973', 'term': 'Alcohol-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Subjects from lead-in study VTI-206 - NCT00973817 lost to follow-up before enrollment in VTI-207 (NCT1452295)', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-03', 'studyFirstSubmitDate': '2011-10-11', 'studyFirstSubmitQcDate': '2011-10-13', 'lastUpdatePostDateStruct': {'date': '2013-12-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-10-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gather data', 'timeFrame': 'Five years post study participation', 'description': 'See previous description'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['liver', 'liver failure', 'acute liver failure', 'ELAD', 'alcoholic hepatitis', 'acute on chronic hepatitis'], 'conditions': ['Acute Liver Failure']}, 'descriptionModule': {'briefSummary': 'VTI-207 (NCT01452295) is designed to follow subjects, both treated and control, for five years after their completion of study participation in protocol VTI-206 (NCT00973817) to gather information relating to the incidence of liver transplant, the incidence and type of cancer (if any), and survival.', 'detailedDescription': 'Vital Therapies, Inc. (VTI) is conducting clinical trial VTI-206 in which subjects with acute on chronic hepatitis (AOCH) and acute alcoholic hepatitis (AAH) are treated with the ELAD system to assess the safety and efficacy of this therapy. The ELAD system incorporates cloned immortalized human liver cells (C3A cells). A hypothetical risk exists that, over an extended period of time, there may be an increased incidence of tumor in subjects treated with ELAD.\n\nThe company is also collecting data related to whether a patient received a liver transplant and on survival.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects participating in the VTI-206 clinical trial.\n\nExclusion Criteria:\n\n* Subjects not participating in the VTI-206 clinical trial.'}, 'identificationModule': {'nctId': 'NCT01452295', 'briefTitle': 'Registry Protocol for Tracking Trial Subjects After VTI-206 Study Completion', 'organization': {'class': 'INDUSTRY', 'fullName': 'Vital Therapies, Inc.'}, 'officialTitle': 'Registry Protocol for Tracking the Incidence of Transplant, the Incidence and Type of Cancer, and Survival Rate of Subjects Participating in Protocol VTI-206 (NCT00973817)', 'orgStudyIdInfo': {'id': 'VTI-207'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AOCH patients', 'description': 'Patients with acute on chronic hepatitis', 'interventionNames': ['Drug: ELAD (Extracorporeal Liver Assist System)']}, {'type': 'EXPERIMENTAL', 'label': 'AAH patients', 'description': 'Patients with acute alcoholic hepatitis', 'interventionNames': ['Drug: ELAD (Extracorporeal Liver Assist System)']}], 'interventions': [{'name': 'ELAD (Extracorporeal Liver Assist System)', 'type': 'DRUG', 'description': 'ELAD (Extracorporeal Liver Assist System)', 'armGroupLabels': ['AAH patients', 'AOCH patients']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Robert A Ashley', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Vital Therapies, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vital Therapies, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}