Ignite Creation Date:
2025-12-24 @ 3:40 PM
Ignite Modification Date:
2026-02-25 @ 4:59 PM
Study NCT ID:
NCT06685692
Status:
COMPLETED
Last Update Posted:
2025-12-12
First Post:
2024-11-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Trial Investigating the Safety and Efficacy of Subjects With Alcohol Associated Hepatitis (Part 1)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006519', 'term': 'Hepatitis, Alcoholic'}], 'ancestors': [{'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000716647', 'term': 'ADX-629'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-11-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2025-06-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-11', 'studyFirstSubmitDate': '2024-11-11', 'studyFirstSubmitQcDate': '2024-11-11', 'lastUpdatePostDateStruct': {'date': '2025-12-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-11-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment-Emergent Adverse Event Query', 'timeFrame': 'Day 1 to Day 28', 'description': 'Incidence and severity of treatment-emergent adverse events'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ADX-629'], 'conditions': ['Alcohol Hepatitis']}, 'descriptionModule': {'briefSummary': 'A Phase 2 Clinical Trial Investigating the Safety and Efficacy of ADX-629 in Subjects with Moderate Alcohol Associated Hepatitis (Part 1)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult ≥ 21 years old on the day of signing the informed consent form;\n* Clinical diagnosis of alcoholic hepatitis, based on clinical features and laboratory testing, confirmed by the Investigator at screening\n* Agreement to abstain from alcohol and utilize resources to cease at-risk behaviors during the trial, including addiction/alcohol abuse treatment\n* Ability and willingness to swallow tablets\n* Willingness to provide signed informed consent, prior to any trial-related procedures and willingness to comply with the trial procedures and requirements\n\nExclusion Criteria:\n\n* Pregnant, intending to become pregnant (or father a child), or breastfeeding\n* Current or recent enrollment in another interventional trial in the 30 days prior to screening'}, 'identificationModule': {'nctId': 'NCT06685692', 'briefTitle': 'A Clinical Trial Investigating the Safety and Efficacy of Subjects With Alcohol Associated Hepatitis (Part 1)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Aldeyra Therapeutics, Inc.'}, 'officialTitle': 'A Phase 2 Clinical Trial Investigating the Safety and Efficacy of ADX-629 in Subjects With Moderate Alcohol Associated Hepatitis', 'orgStudyIdInfo': {'id': 'ADX-629-ALH-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ADX-629 (125 mg twice daily)', 'interventionNames': ['Drug: ADX-629']}, {'type': 'EXPERIMENTAL', 'label': 'ADX-629 (250 mg twice daily)', 'interventionNames': ['Drug: ADX-629']}], 'interventions': [{'name': 'ADX-629', 'type': 'DRUG', 'description': '125 mg twice daily for 28 days', 'armGroupLabels': ['ADX-629 (125 mg twice daily)']}, {'name': 'ADX-629', 'type': 'DRUG', 'description': '250 mg twice daily for 28 days', 'armGroupLabels': ['ADX-629 (250 mg twice daily)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34209', 'city': 'Bradenton', 'state': 'Florida', 'country': 'United States', 'facility': 'Synergry Healthcare', 'geoPoint': {'lat': 27.49893, 'lon': -82.57482}}, {'zip': '33606', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Health Sciences Center/Tampa General Hospital/USF', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '75203', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'The Liver Institute at Methodist Dallas Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77057', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'UDL Clinical Research, LLC', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Methodist Specialty and Transplant Hospital', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '23221', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Bon Secours Liver Institute of Newport News', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aldeyra Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}