Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2026-03-26 @ 10:56 PM
Study NCT ID:
NCT03432260
Status:
COMPLETED
Last Update Posted:
2024-09-24
First Post:
2018-02-01
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Research Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of DUR-928 in Patients With Alcoholic Hepatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-10-28', 'type': 'ACTUAL'}}}}, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jill.burns@durect.com', 'phone': '408-777-1418', 'title': 'Director of Regulatory Affairs', 'organization': 'DURECT Corporation'}, 'certainAgreement': {'otherDetails': 'If a joint publication is not submitted within 18-24 months after study completion, PI shall have the right to submit to sponsor a proposed results communication based on results at their institution. Sponsor can review proposed results communications prior to public release, can request removal of confidential information, and can embargo communications regarding trial results for up to 120-180 days after submission to sponsor.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '28 days', 'description': 'If subject was not available in person, they were contacted via phone.', 'eventGroups': [{'id': 'EG000', 'title': 'Moderate AH DUR-928 30 mg', 'description': 'Part A (Moderate AH) Lowest dose of doses investigated: 30 mg, 90 mg, 150 mg\n\nDUR-928: Dose escalation including 2 doses: 30mg and 90 mg (150 mg did not enroll)', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Moderate AH DUR-928 90 mg', 'description': 'Part A (Moderate AH) Middle dose of doses investigated: 30 mg, 90 mg, 150 mg\n\nDUR-928: Dose escalation including 2 doses: 30mg and 90 mg (150 mg did not enroll)', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 2, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Severe AH DUR-928 30 mg', 'description': 'Part B (Severe AH) Lowest dose of doses investigated: 30mg, 90 mg and 150 mg\n\nDUR-928: Dose escalation including 3 doses: 30mg, 90 mg and 150 mg', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 3, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG003', 'title': 'Severe AH DUR-928 90 mg', 'description': 'Part B (Severe AH) Middle dose of doses investigated: 30mg, 90 mg and 150 mg\n\nDUR-928: Dose escalation including 3 doses: 30mg, 90 mg and 150 mg', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 3, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG004', 'title': 'Severe AH DUR-928 150 mg', 'description': 'Part B (Severe AH) Highest dose of doses investigated: 30mg, 90 mg and 150 mg\n\nDUR-928: Dose escalation including 3 doses: 30mg, 90 mg and 150 mg', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 3, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Food poisoning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Acne', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Pruritus generalised', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Renal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Sinus congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}], 'seriousEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Hematemesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Fluid overload', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Hypokalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Lille Model for Alcoholic Hepatitis Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Moderate AH DUR-928 30 mg', 'description': 'Part A (Moderate AH) Lowest dose of doses investigated: 30 mg, 90 mg, 150 mg\n\nDUR-928: Dose escalation including 2 doses: 30mg and 90 mg (150 mg did not enroll)'}, {'id': 'OG001', 'title': 'Moderate AH DUR-928 90 mg', 'description': 'Part A (Moderate AH) Middle dose of doses investigated: 30 mg, 90 mg, 150 mg\n\nDUR-928: Dose escalation including 2 doses: 30mg and 90 mg (150 mg did not enroll)'}, {'id': 'OG002', 'title': 'Severe AH DUR-928 30 mg', 'description': 'Part B (Severe AH) Lowest dose of doses investigated: 30mg, 90 mg and 150 mg\n\nDUR-928: Dose escalation including 3 doses: 30mg, 90 mg and 150 mg'}, {'id': 'OG003', 'title': 'Severe AH DUR-928 90 mg', 'description': 'Part B (Severe AH) Middle dose of doses investigated: 30mg, 90 mg and 150 mg\n\nDUR-928: Dose escalation including 3 doses: 30mg, 90 mg and 150 mg'}, {'id': 'OG004', 'title': 'Severe AH DUR-928 150 mg', 'description': 'Part B (Severe AH) Highest dose of doses investigated: 30mg, 90 mg and 150 mg\n\nDUR-928: Dose escalation including 3 doses: 30mg, 90 mg and 150 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '0.020', 'groupId': 'OG000', 'lowerLimit': '0.01', 'upperLimit': '0.04'}, {'value': '0.050', 'groupId': 'OG001', 'lowerLimit': '0.01', 'upperLimit': '0.05'}, {'value': '0.155', 'groupId': 'OG002', 'lowerLimit': '0.05', 'upperLimit': '0.19'}, {'value': '0.195', 'groupId': 'OG003', 'lowerLimit': '0.04', 'upperLimit': '0.24'}, {'value': '0.420', 'groupId': 'OG004', 'lowerLimit': '0.08', 'upperLimit': '0.87'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 7', 'description': 'The Lille score predicts response of AH subjects to treatment with glucocorticoids, such as prednisolone. This score is based on age, serum albumin, creatinine, PT, and the difference in bilirubin between pre-treatment and Day 7 post-treatment. The Lille score ranges from 0.01 to 1.00. A score \\>0.45 predicts a higher risk of death and the recommendation to stop steroid administration.\n\nLille Score = Exp(-R)/(1 + Exp(-R))\n\nWhere:\n\nR = \\[3.19 - (0.101 x Age in years)\\] + (1.47 x Albumin in g/dL) + \\[0.28215 x (Bilirubin initial - Bilirubin day 7 in mg/dL)\\] - (0.206 x Creatinine in mg/dL) - (0.11115 x Bilirubin initial in mg/dL) - (0.0096 x PT in seconds) NOTE: When calculating Lille, use "baseline" values for ALL parameters EXCEPT bilirubin at Day 7. Baseline would be the Day 1 Pre-dose sample result, if available. If not available, then use the Screening sample result.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'PRIMARY', 'title': 'Model for End Stage Liver Disease (MELD) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Moderate AH DUR-928 30 mg', 'description': 'Part A (Moderate AH) Lowest dose of doses investigated: 30 mg, 90 mg, 150 mg\n\nDUR-928: Dose escalation including 2 doses: 30mg and 90 mg (150 mg did not enroll)'}, {'id': 'OG001', 'title': 'Moderate AH DUR-928 90 mg', 'description': 'Part A (Moderate AH) Middle dose of doses investigated: 30 mg, 90 mg, 150 mg\n\nDUR-928: Dose escalation including 2 doses: 30mg and 90 mg (150 mg did not enroll)'}, {'id': 'OG002', 'title': 'Severe AH DUR-928 30 mg', 'description': 'Part B (Severe AH) Lowest dose of doses investigated: 30mg, 90 mg and 150 mg\n\nDUR-928: Dose escalation including 3 doses: 30mg, 90 mg and 150 mg'}, {'id': 'OG003', 'title': 'Severe AH DUR-928 90 mg', 'description': 'Part B (Severe AH) Middle dose of doses investigated: 30mg, 90 mg and 150 mg\n\nDUR-928: Dose escalation including 3 doses: 30mg, 90 mg and 150 mg'}, {'id': 'OG004', 'title': 'Severe AH DUR-928 150 mg', 'description': 'Part B (Severe AH) Highest dose of doses investigated: 30mg, 90 mg and 150 mg\n\nDUR-928: Dose escalation including 3 doses: 30mg, 90 mg and 150 mg'}], 'classes': [{'title': 'Screening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '19.5', 'groupId': 'OG000', 'lowerLimit': '15', 'upperLimit': '20'}, {'value': '19.0', 'groupId': 'OG001', 'lowerLimit': '14', 'upperLimit': '21'}, {'value': '24.5', 'groupId': 'OG002', 'lowerLimit': '21', 'upperLimit': '28'}, {'value': '24.5', 'groupId': 'OG003', 'lowerLimit': '21', 'upperLimit': '28'}, {'value': '25.0', 'groupId': 'OG004', 'lowerLimit': '23', 'upperLimit': '27'}]}]}, {'title': 'Day 1 Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG001', 'lowerLimit': '20', 'upperLimit': '20'}, {'value': '23.0', 'groupId': 'OG002', 'lowerLimit': '21', 'upperLimit': '26'}, {'value': '24.0', 'groupId': 'OG003', 'lowerLimit': '24', 'upperLimit': '24'}, {'value': '23.0', 'groupId': 'OG004', 'lowerLimit': '21', 'upperLimit': '26'}]}]}, {'title': 'Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '17.0', 'groupId': 'OG000', 'lowerLimit': '16', 'upperLimit': '19'}, {'value': '17.0', 'groupId': 'OG001', 'lowerLimit': '11', 'upperLimit': '19'}, {'value': '23.5', 'groupId': 'OG002', 'lowerLimit': '21', 'upperLimit': '29'}, {'value': '24.0', 'groupId': 'OG003', 'lowerLimit': '21', 'upperLimit': '29'}, {'value': '24.0', 'groupId': 'OG004', 'lowerLimit': '21', 'upperLimit': '28'}]}]}, {'title': 'Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '15.0', 'groupId': 'OG000', 'lowerLimit': '12', 'upperLimit': '20'}, {'value': '11.5', 'groupId': 'OG001', 'lowerLimit': '8', 'upperLimit': '15'}, {'value': '19.0', 'groupId': 'OG002', 'lowerLimit': '16', 'upperLimit': '24'}, {'value': '23.5', 'groupId': 'OG003', 'lowerLimit': '17', 'upperLimit': '28'}, {'value': '23.0', 'groupId': 'OG004', 'lowerLimit': '19', 'upperLimit': '29'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline (Screening or Day 1 Pre-dose), Day 7 and Day 28', 'description': 'The MELD score at enrollment is a good predictor for AH patient prognosis. Laboratory values for international normalized ratio (INR), serum creatinine (sCr) and bilirubin are used to calculate the MELD score. The MELD score ranges from 6.0 to 40.0 (capped) with a higher score predicting a higher risk of death. A sequentially improving MELD score is associated with a better chance of recovery.\n\nMELD score will be calculated using the original formula (pre-2016) which does not include serum sodium level.\n\nOriginal MELD Score = (0.957 x Ln(Serum Creatinine in mg/dL) + 0. 378 x Ln(Serum Bilirubin in mg/dL) + 1.120 x Ln (INR) + 0.643) x 10 Note: (1) If patient received two or more dialysis treatments within the prior 7 days, then the value for serum creatinine will be set to 4.0. (2) If any laboratory value is less than 1.0, the value will be set to 1.0 for the MELD score calculation, in order to avoid negative values resulting from taking the natural log of values less than 1.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT, baseline was defined as the last non-missing value prior to study drug administration, at Screening or Day 1 Pre-dose'}, {'type': 'PRIMARY', 'title': 'Model for End Stage Liver Disease (MELD) Score - Percent Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Moderate AH DUR-928 30 mg', 'description': 'Part A (Moderate AH) Lowest dose of doses investigated: 30 mg, 90 mg, 150 mg\n\nDUR-928: Dose escalation including 2 doses: 30mg and 90 mg (150 mg did not enroll)'}, {'id': 'OG001', 'title': 'Moderate AH DUR-928 90 mg', 'description': 'Part A (Moderate AH) Middle dose of doses investigated: 30 mg, 90 mg, 150 mg\n\nDUR-928: Dose escalation including 2 doses: 30mg and 90 mg (150 mg did not enroll)'}, {'id': 'OG002', 'title': 'Severe AH DUR-928 30 mg', 'description': 'Part B (Severe AH) Lowest dose of doses investigated: 30mg, 90 mg and 150 mg\n\nDUR-928: Dose escalation including 3 doses: 30mg, 90 mg and 150 mg'}, {'id': 'OG003', 'title': 'Severe AH DUR-928 90 mg', 'description': 'Part B (Severe AH) Middle dose of doses investigated: 30mg, 90 mg and 150 mg\n\nDUR-928: Dose escalation including 3 doses: 30mg, 90 mg and 150 mg'}, {'id': 'OG004', 'title': 'Severe AH DUR-928 150 mg', 'description': 'Part B (Severe AH) Highest dose of doses investigated: 30mg, 90 mg and 150 mg\n\nDUR-928: Dose escalation including 3 doses: 30mg, 90 mg and 150 mg'}], 'classes': [{'title': 'Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-5.00', 'groupId': 'OG000', 'lowerLimit': '-10.5', 'upperLimit': '6.7'}, {'value': '-10.53', 'groupId': 'OG001', 'lowerLimit': '-21.4', 'upperLimit': '-5.0'}, {'value': '0.00', 'groupId': 'OG002', 'lowerLimit': '-8.7', 'upperLimit': '3.6'}, {'value': '0.00', 'groupId': 'OG003', 'lowerLimit': '-4.0', 'upperLimit': '3.6'}, {'value': '0.00', 'groupId': 'OG004', 'lowerLimit': '-4.3', 'upperLimit': '3.7'}]}]}, {'title': 'Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-20.00', 'groupId': 'OG000', 'lowerLimit': '-21.1', 'upperLimit': '0.00'}, {'value': '-33.93', 'groupId': 'OG001', 'lowerLimit': '-42.9', 'upperLimit': '-25.0'}, {'value': '-26.76', 'groupId': 'OG002', 'lowerLimit': '-35.7', 'upperLimit': '14.3'}, {'value': '-8.00', 'groupId': 'OG003', 'lowerLimit': '-19.0', 'upperLimit': '8.3'}, {'value': '0.00', 'groupId': 'OG004', 'lowerLimit': '-29.6', 'upperLimit': '11.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline (Screening or Day 1 Pre-dose), Day 7 and Day 28', 'description': 'The MELD Score %change from baseline is a %change between 2 time points, baseline and value at a specific time point (Day 7 or Day 28). MELD score is a good predictor of outcome. A declining MELD score suggests disease improvement. Lab values for international normalized ratio (INR), serum creatinine (sCr) and bilirubin are used to calculate the MELD score. MELD score will be calculated using the original formula (pre-2016) which does not include serum sodium level. Original MELD Score = (0.957 x Ln(Serum Creatinine in mg/dL) + 0. 378 x Ln(Serum Bilirubin in mg/dL) + 1.120 x Ln (INR) + 0.643) x 10 Note: (1) If patient received two or more dialysis treatments within the prior 7 days, then the value for serum creatinine will be set to 4.0. (2) If any laboratory value is less than 1.0, the value will be set to 1.0 for the MELD score calculation, in order to avoid negative values resulting from taking the natural log of values less than 1.', 'unitOfMeasure': 'Percent Change', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Serum Cytokeratin 18 (M30)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Moderate AH DUR-928 30 mg', 'description': 'Part A (Moderate AH) Lowest dose of doses investigated: 30 mg, 90 mg, 150 mg DUR-928: Dose escalation including 2 doses: 30mg and 90 mg (150 mg did not enroll)'}, {'id': 'OG001', 'title': 'Moderate AH DUR-928 90 mg', 'description': 'Part A (Moderate AH) Middle dose of doses investigated: 30 mg, 90 mg, 150 mg DUR-928: Dose escalation including 2 doses: 30mg and 90 mg (150 mg did not enroll)'}, {'id': 'OG002', 'title': 'Severe AH DUR-928 30 mg', 'description': 'Part B (Severe AH) Lowest dose of doses investigated: 30mg, 90 mg and 150 mg\n\nDUR-928: Dose escalation including 3 doses: 30mg, 90 mg and 150 mg'}, {'id': 'OG003', 'title': 'Severe AH DUR-928 90 mg', 'description': 'Part B (Severe AH) Middle dose of doses investigated: 30mg, 90 mg and 150 mg\n\nDUR-928: Dose escalation including 3 doses: 30mg, 90 mg and 150 mg'}, {'id': 'OG004', 'title': 'Severe AH DUR-928 150 mg', 'description': 'Part B (Severe AH) Highest dose of doses investigated: 30mg, 90 mg and 150 mg\n\nDUR-928: Dose escalation including 3 doses: 30mg, 90 mg and 150 mg'}], 'classes': [{'title': 'Day 1-Predose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '723.5', 'groupId': 'OG000', 'lowerLimit': '334', 'upperLimit': '2255'}, {'value': '737', 'groupId': 'OG001', 'lowerLimit': '467', 'upperLimit': '4000'}, {'value': '1443.5', 'groupId': 'OG002', 'lowerLimit': '561', 'upperLimit': '4000'}, {'value': '1946', 'groupId': 'OG003', 'lowerLimit': '292', 'upperLimit': '4000'}, {'value': '931', 'groupId': 'OG004', 'lowerLimit': '752', 'upperLimit': '1766'}]}]}, {'title': 'Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '526', 'groupId': 'OG000', 'lowerLimit': '257', 'upperLimit': '3150'}, {'value': '3112', 'groupId': 'OG001', 'lowerLimit': '2124', 'upperLimit': '3440'}, {'value': '3305.5', 'groupId': 'OG002', 'lowerLimit': '500', 'upperLimit': '4000'}, {'value': '1702.0', 'groupId': 'OG003', 'lowerLimit': '323', 'upperLimit': '4000'}, {'value': '1012.5', 'groupId': 'OG004', 'lowerLimit': '439', 'upperLimit': '4000'}]}]}, {'title': 'Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '2205.5', 'groupId': 'OG001', 'lowerLimit': '411', 'upperLimit': '4000'}, {'value': '1114.0', 'groupId': 'OG002', 'lowerLimit': '612', 'upperLimit': '3160'}, {'value': '550.5', 'groupId': 'OG003', 'lowerLimit': '243', 'upperLimit': '4000'}, {'value': '161.0', 'groupId': 'OG004', 'lowerLimit': '108', 'upperLimit': '4000'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline (Screening or Day 1 Pre-dose), Day 7, Day 28', 'description': 'Analysis Population Description: Baseline was defined as the last non-missing value prior to study drug administration, at Screening or Day 1 Pre-dose.', 'unitOfMeasure': 'U/L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Number analyzed is dependent on samples being collected and evaluable.'}, {'type': 'SECONDARY', 'title': 'Serum Cytokeratin 18 (M65)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Moderate AH DUR-928 30 mg', 'description': 'Part A (Moderate AH) Lowest dose of doses investigated: 30 mg, 90 mg, 150 mg DUR-928: Dose escalation including 2 doses: 30mg and 90 mg (150 mg did not enroll)'}, {'id': 'OG001', 'title': 'Moderate AH DUR-928 90 mg', 'description': 'Part A (Moderate AH) Middle dose of doses investigated: 30 mg, 90 mg, 150 mg DUR-928: Dose escalation including 2 doses: 30mg and 90 mg (150 mg did not enroll)'}, {'id': 'OG002', 'title': 'Severe AH DUR-928 30 mg', 'description': 'Part B (Severe AH) Lowest dose of doses investigated: 30mg, 90 mg and 150 mg\n\nDUR-928: Dose escalation including 3 doses: 30mg, 90 mg and 150 mg'}, {'id': 'OG003', 'title': 'Severe AH DUR-928 90 mg', 'description': 'Part B (Severe AH) Middle dose of doses investigated: 30mg, 90 mg and 150 mg\n\nDUR-928: Dose escalation including 3 doses: 30mg, 90 mg and 150 mg'}, {'id': 'OG004', 'title': 'Severe AH DUR-928 150 mg', 'description': 'Part B (Severe AH) Highest dose of doses investigated: 30mg, 90 mg and 150 mg\n\nDUR-928: Dose escalation including 3 doses: 30mg, 90 mg and 150 mg'}], 'classes': [{'title': 'Day 1-Predose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '252.5', 'groupId': 'OG000', 'lowerLimit': '217', 'upperLimit': '2074'}, {'value': '1791.0', 'groupId': 'OG001', 'lowerLimit': '729', 'upperLimit': '14208'}, {'value': '3033.5', 'groupId': 'OG002', 'lowerLimit': '750', 'upperLimit': '20000'}, {'value': '4071.5', 'groupId': 'OG003', 'lowerLimit': '225', 'upperLimit': '20000'}, {'value': '1999.0', 'groupId': 'OG004', 'lowerLimit': '1777', 'upperLimit': '2209'}]}]}, {'title': 'Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '353.0', 'groupId': 'OG000', 'lowerLimit': '119', 'upperLimit': '3029'}, {'value': '4697.0', 'groupId': 'OG001', 'lowerLimit': '4416', 'upperLimit': '9928'}, {'value': '7303.0', 'groupId': 'OG002', 'lowerLimit': '709', 'upperLimit': '20000'}, {'value': '4397.5', 'groupId': 'OG003', 'lowerLimit': '234', 'upperLimit': '20000'}, {'value': '3994.5', 'groupId': 'OG004', 'lowerLimit': '502', 'upperLimit': '15028'}]}]}, {'title': 'Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '4771.5', 'groupId': 'OG001', 'lowerLimit': '807', 'upperLimit': '8736'}, {'value': '2426.0', 'groupId': 'OG002', 'lowerLimit': '998', 'upperLimit': '7420'}, {'value': '1224.5', 'groupId': 'OG003', 'lowerLimit': '224', 'upperLimit': '17232'}, {'value': '1987.0', 'groupId': 'OG004', 'lowerLimit': '452', 'upperLimit': '3246'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline (Screening or Day 1 Pre-dose), Day 7, Day 28', 'description': 'Analysis Population Description: Baseline was defined as the last non-missing value prior to study drug administration, at Screening or Day 1 Pre-dose.', 'unitOfMeasure': 'U/L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Number analyzed is dependent on samples being collected and evaluable.'}, {'type': 'SECONDARY', 'title': 'International Normalized Ratio (INR) - Percent Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Moderate AH DUR-928 30 mg', 'description': 'Part A (Moderate AH) Lowest dose of doses investigated: 30 mg, 90 mg, 150 mg\n\nDUR-928: Dose escalation including 2 doses: 30mg and 90 mg (150 mg did not enroll)'}, {'id': 'OG001', 'title': 'Moderate AH DUR-928 90 mg', 'description': 'Part A (Moderate AH) Middle dose of doses investigated: 30 mg, 90 mg, 150 mg\n\nDUR-928: Dose escalation including 2 doses: 30mg and 90 mg (150 mg did not enroll)'}, {'id': 'OG002', 'title': 'Severe AH DUR-928 30 mg', 'description': 'Part B (Severe AH) Lowest dose of doses investigated: 30mg, 90 mg and 150 mg\n\nDUR-928: Dose escalation including 3 doses: 30mg, 90 mg and 150 mg'}, {'id': 'OG003', 'title': 'Severe AH DUR-928 90 mg', 'description': 'Part B (Severe AH) Middle dose of doses investigated: 30mg, 90 mg and 150 mg\n\nDUR-928: Dose escalation including 3 doses: 30mg, 90 mg and 150 mg'}, {'id': 'OG004', 'title': 'Severe AH DUR-928 150 mg', 'description': 'Part B (Severe AH) Highest dose of doses investigated: 30mg, 90 mg and 150 mg\n\nDUR-928: Dose escalation including 3 doses: 30mg, 90 mg and 150 mg'}], 'classes': [{'title': 'Day 7 Percent Change from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-10.000', 'groupId': 'OG000', 'lowerLimit': '-11.11', 'upperLimit': '7.35'}, {'value': '-3.226', 'groupId': 'OG001', 'lowerLimit': '-8.33', 'upperLimit': '7.14'}, {'value': '4.768', 'groupId': 'OG002', 'lowerLimit': '-8.88', 'upperLimit': '10.53'}, {'value': '0.000', 'groupId': 'OG003', 'lowerLimit': '-5.26', 'upperLimit': '43.75'}, {'value': '0.000', 'groupId': 'OG004', 'lowerLimit': '-8.33', 'upperLimit': '6.67'}]}]}, {'title': 'Day 28 Percent Change from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-3.676', 'groupId': 'OG000', 'lowerLimit': '-22.22', 'upperLimit': '0.00'}, {'value': '0.000', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '0.00'}, {'value': '-19.402', 'groupId': 'OG002', 'lowerLimit': '-29.68', 'upperLimit': '17.65'}, {'value': '-3.180', 'groupId': 'OG003', 'lowerLimit': '-21.05', 'upperLimit': '18.75'}, {'value': '0.000', 'groupId': 'OG004', 'lowerLimit': '-33.33', 'upperLimit': '42.11'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline (Screening or Day 1 Pre-dose), Day 7, Day 28', 'description': 'ITT population. INR (international normalized ratio) is a standardized number based on the prothrombin time and calculated by the clinical lab. INR measures the time it takes for blood to clot in vitro and measures, among other things, liver synthetic function.', 'unitOfMeasure': 'Percent Change', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Baseline is defined as the last non-missing value prior to study drug administration, at Screening or Day 1 Pre-dose'}, {'type': 'SECONDARY', 'title': 'Bilirubin - Percent Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Moderate AH DUR-928 30 mg', 'description': 'Part A (Moderate AH) Lowest dose of doses investigated: 30 mg, 90 mg, 150 mg\n\nDUR-928: Dose escalation including 2 doses: 30mg and 90 mg (150 mg did not enroll)'}, {'id': 'OG001', 'title': 'Moderate AH DUR-928 90 mg', 'description': 'Part A (Moderate AH) Middle dose of doses investigated: 30 mg, 90 mg, 150 mg\n\nDUR-928: Dose escalation including 2 doses: 30mg and 90 mg (150 mg did not enroll)'}, {'id': 'OG002', 'title': 'Severe AH DUR-928 30 mg', 'description': 'Part B (Severe AH) Lowest dose of doses investigated: 30mg, 90 mg and 150 mg\n\nDUR-928: Dose escalation including 3 doses: 30mg, 90 mg and 150 mg'}, {'id': 'OG003', 'title': 'Severe AH DUR-928 90 mg', 'description': 'Part B (Severe AH) Middle dose of doses investigated: 30mg, 90 mg and 150 mg\n\nDUR-928: Dose escalation including 3 doses: 30mg, 90 mg and 150 mg'}, {'id': 'OG004', 'title': 'Severe AH DUR-928 150 mg', 'description': 'Part B (Severe AH) Highest dose of doses investigated: 30mg, 90 mg and 150 mg\n\nDUR-928: Dose escalation including 3 doses: 30mg, 90 mg and 150 mg'}], 'classes': [{'title': 'Day 7 Percent Change from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-15.69', 'groupId': 'OG000', 'lowerLimit': '-34.5', 'upperLimit': '17.1'}, {'value': '-31.03', 'groupId': 'OG001', 'lowerLimit': '-43.9', 'upperLimit': '-29.3'}, {'value': '-25.19', 'groupId': 'OG002', 'lowerLimit': '-49.8', 'upperLimit': '-9.0'}, {'value': '-6.48', 'groupId': 'OG003', 'lowerLimit': '-25.1', 'upperLimit': '6.6'}, {'value': '4.96', 'groupId': 'OG004', 'lowerLimit': '-29.3', 'upperLimit': '24.7'}]}]}, {'title': 'Day 28 Percent Change from Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-27.27', 'groupId': 'OG000', 'lowerLimit': '-40.0', 'upperLimit': '-5.9'}, {'value': '-74.27', 'groupId': 'OG001', 'lowerLimit': '-75.6', 'upperLimit': '-72.9'}, {'value': '-56.93', 'groupId': 'OG002', 'lowerLimit': '-74.1', 'upperLimit': '34.0'}, {'value': '-34.82', 'groupId': 'OG003', 'lowerLimit': '-47.9', 'upperLimit': '50.0'}, {'value': '-10.04', 'groupId': 'OG004', 'lowerLimit': '-63.6', 'upperLimit': '1.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline (Screening or Day 1 Pre-dose), Day 7, Day 28', 'description': 'ITT population', 'unitOfMeasure': 'Percent Change', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Baseline is defined as the last non-missing value prior to study drug administration, at Screening or Day 1 Pre-dose'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Serum Creatinine (sCR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Moderate AH DUR-928 30 mg', 'description': 'Part A (Moderate AH) Lowest dose of doses investigated: 30 mg, 90 mg, 150 mg\n\nDUR-928: Dose escalation including 2 doses: 30mg and 90 mg (150 mg did not enroll)'}, {'id': 'OG001', 'title': 'Moderate AH DUR-928 90 mg', 'description': 'Part A (Moderate AH) Middle dose of doses investigated: 30 mg, 90 mg, 150 mg\n\nDUR-928: Dose escalation including 2 doses: 30mg and 90 mg (150 mg did not enroll)'}, {'id': 'OG002', 'title': 'Severe AH DUR-928 30 mg', 'description': 'Part B (Severe AH) Lowest dose of doses investigated: 30mg, 90 mg and 150 mg\n\nDUR-928: Dose escalation including 3 doses: 30mg, 90 mg and 150 mg'}, {'id': 'OG003', 'title': 'Severe AH DUR-928 90 mg', 'description': 'Part B (Severe AH) Middle dose of doses investigated: 30mg, 90 mg and 150 mg\n\nDUR-928: Dose escalation including 3 doses: 30mg, 90 mg and 150 mg'}, {'id': 'OG004', 'title': 'Severe AH DUR-928 150 mg', 'description': 'Part B (Severe AH) Highest dose of doses investigated: 30mg, 90 mg and 150 mg\n\nDUR-928: Dose escalation including 3 doses: 30mg, 90 mg and 150 mg'}], 'classes': [{'title': 'Baseline (Screening)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0.620', 'groupId': 'OG000', 'lowerLimit': '0.46', 'upperLimit': '0.80'}, {'value': '0.710', 'groupId': 'OG001', 'lowerLimit': '0.2', 'upperLimit': '0.84'}, {'value': '0.795', 'groupId': 'OG002', 'lowerLimit': '0.63', 'upperLimit': '1.20'}, {'value': '0.765', 'groupId': 'OG003', 'lowerLimit': '0.59', 'upperLimit': '1.50'}, {'value': '0.610', 'groupId': 'OG004', 'lowerLimit': '0.50', 'upperLimit': '1.00'}]}]}, {'title': 'Baseline (Day 1-Pre dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0.660', 'groupId': 'OG001', 'lowerLimit': '0.66', 'upperLimit': '0.66'}, {'value': '0.640', 'groupId': 'OG002', 'lowerLimit': '0.61', 'upperLimit': '0.78'}, {'value': '0.580', 'groupId': 'OG003', 'lowerLimit': '0.58', 'upperLimit': '0.58'}, {'value': '0.520', 'groupId': 'OG004', 'lowerLimit': '0.50', 'upperLimit': '0.70'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline (Screening or Day 1 Pre-dose)', 'description': 'Serum Creatinine (sCR) at baseline is provided as part of the calculation for MELD', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Baseline was defined as the last non-missing value prior to study drug administration, at Screening or Day 1 Pre-dose.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Moderate AH DUR-928 30 mg', 'description': 'Part A (Moderate AH) Lowest dose of doses investigated: 30 mg, 90 mg, 150 mg DUR-928: Dose escalation including 2 doses: 30mg and 90 mg (150 mg did not enroll)'}, {'id': 'FG001', 'title': 'Moderate AH DUR-928 90 mg', 'description': 'Part A (Moderate AH) Middle dose of doses investigated: 30 mg, 90 mg, 150 mg DUR-928: Dose escalation including 2 doses: 30mg and 90 mg (150 mg did not enroll)'}, {'id': 'FG002', 'title': 'Severe AH DUR-928 30 mg', 'description': 'Part B (Severe AH) Lowest dose of doses investigated: 30mg, 90 mg and 150 mg\n\nDUR-928: Dose escalation including 3 doses: 30mg, 90 mg and 150 mg'}, {'id': 'FG003', 'title': 'Severe AH DUR-928 90 mg', 'description': 'Part B (Severe AH) Middle dose of doses investigated: 30mg, 90 mg and 150 mg\n\nDUR-928: Dose escalation including 3 doses: 30mg, 90 mg and 150 mg'}, {'id': 'FG004', 'title': 'Severe AH DUR-928 150 mg', 'description': 'Part B (Severe AH) Highest dose of doses investigated: 30mg, 90 mg and 150 mg\n\nDUR-928: Dose escalation including 3 doses: 30mg, 90 mg and 150 mg'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Part A (Moderate AH) and Part B (Severe AH) were assigned treatments in a dose escalation, staggered parallel design.\n\nPart A (Moderate AH) highest dose of dose escalation arms (150 mg) was not enrolled.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '19', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Moderate AH DUR-928 30 mg', 'description': 'Part A (Moderate AH) Lowest dose of doses investigated: 30 mg, 90 mg, 150 mg\n\nDUR-928: Dose escalation including 2 doses: 30mg and 90 mg (150 mg did not enroll)'}, {'id': 'BG001', 'title': 'Moderate AH DUR-928 90 mg', 'description': 'Part A (Moderate AH) Middle dose of doses investigated: 30 mg, 90 mg, 150 mg\n\nDUR-928: Dose escalation including 2 doses: 30mg and 90 mg (150 mg did not enroll)'}, {'id': 'BG002', 'title': 'Severe AH DUR-928 30 mg', 'description': 'Part B (Severe AH) Lowest dose of doses investigated: 30mg, 90 mg and 150 mg\n\nDUR-928: Dose escalation including 3 doses: 30mg, 90 mg and 150 mg'}, {'id': 'BG003', 'title': 'Severe AH DUR-928 90 mg', 'description': 'Part B (Severe AH) Middle dose of doses investigated: 30mg, 90 mg and 150 mg\n\nDUR-928: Dose escalation including 3 doses: 30mg, 90 mg and 150 mg'}, {'id': 'BG004', 'title': 'Severe AH DUR-928 150 mg', 'description': 'Part B (Severe AH) Highest dose of doses investigated: 30mg, 90 mg and 150 mg\n\nDUR-928: Dose escalation including 3 doses: 30mg, 90 mg and 150 mg'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '36.5', 'groupId': 'BG000', 'lowerLimit': '33.0', 'upperLimit': '39.5'}, {'value': '42.0', 'groupId': 'BG001', 'lowerLimit': '33.0', 'upperLimit': '43.0'}, {'value': '45.0', 'groupId': 'BG002', 'lowerLimit': '37.5', 'upperLimit': '52.5'}, {'value': '43.5', 'groupId': 'BG003', 'lowerLimit': '40.0', 'upperLimit': '45.0'}, {'value': '40.5', 'groupId': 'BG004', 'lowerLimit': '35.5', 'upperLimit': '46.0'}, {'value': '41.0', 'groupId': 'BG005', 'lowerLimit': '35.0', 'upperLimit': '45.0'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '8', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '11', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '7', 'groupId': 'BG005'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '12', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}]}, {'title': 'White', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '17', 'groupId': 'BG005'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '19', 'groupId': 'BG005'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-09-19', 'size': 1754522, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-11-18T12:50', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Staggered parallel design.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'dispFirstSubmitDate': '2020-10-01', 'completionDateStruct': {'date': '2019-09-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-28', 'studyFirstSubmitDate': '2018-02-01', 'dispFirstSubmitQcDate': '2022-11-18', 'resultsFirstSubmitDate': '2022-09-29', 'studyFirstSubmitQcDate': '2018-02-07', 'dispFirstPostDateStruct': {'date': '2022-12-14', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2024-09-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-11-18', 'studyFirstPostDateStruct': {'date': '2018-02-14', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-12-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Serum Creatinine (sCR)', 'timeFrame': 'Baseline (Screening or Day 1 Pre-dose)', 'description': 'Serum Creatinine (sCR) at baseline is provided as part of the calculation for MELD'}], 'primaryOutcomes': [{'measure': 'Lille Model for Alcoholic Hepatitis Score', 'timeFrame': 'Day 7', 'description': 'The Lille score predicts response of AH subjects to treatment with glucocorticoids, such as prednisolone. This score is based on age, serum albumin, creatinine, PT, and the difference in bilirubin between pre-treatment and Day 7 post-treatment. The Lille score ranges from 0.01 to 1.00. A score \\>0.45 predicts a higher risk of death and the recommendation to stop steroid administration.\n\nLille Score = Exp(-R)/(1 + Exp(-R))\n\nWhere:\n\nR = \\[3.19 - (0.101 x Age in years)\\] + (1.47 x Albumin in g/dL) + \\[0.28215 x (Bilirubin initial - Bilirubin day 7 in mg/dL)\\] - (0.206 x Creatinine in mg/dL) - (0.11115 x Bilirubin initial in mg/dL) - (0.0096 x PT in seconds) NOTE: When calculating Lille, use "baseline" values for ALL parameters EXCEPT bilirubin at Day 7. Baseline would be the Day 1 Pre-dose sample result, if available. If not available, then use the Screening sample result.'}, {'measure': 'Model for End Stage Liver Disease (MELD) Score', 'timeFrame': 'Baseline (Screening or Day 1 Pre-dose), Day 7 and Day 28', 'description': 'The MELD score at enrollment is a good predictor for AH patient prognosis. Laboratory values for international normalized ratio (INR), serum creatinine (sCr) and bilirubin are used to calculate the MELD score. The MELD score ranges from 6.0 to 40.0 (capped) with a higher score predicting a higher risk of death. A sequentially improving MELD score is associated with a better chance of recovery.\n\nMELD score will be calculated using the original formula (pre-2016) which does not include serum sodium level.\n\nOriginal MELD Score = (0.957 x Ln(Serum Creatinine in mg/dL) + 0. 378 x Ln(Serum Bilirubin in mg/dL) + 1.120 x Ln (INR) + 0.643) x 10 Note: (1) If patient received two or more dialysis treatments within the prior 7 days, then the value for serum creatinine will be set to 4.0. (2) If any laboratory value is less than 1.0, the value will be set to 1.0 for the MELD score calculation, in order to avoid negative values resulting from taking the natural log of values less than 1.'}, {'measure': 'Model for End Stage Liver Disease (MELD) Score - Percent Change From Baseline', 'timeFrame': 'Baseline (Screening or Day 1 Pre-dose), Day 7 and Day 28', 'description': 'The MELD Score %change from baseline is a %change between 2 time points, baseline and value at a specific time point (Day 7 or Day 28). MELD score is a good predictor of outcome. A declining MELD score suggests disease improvement. Lab values for international normalized ratio (INR), serum creatinine (sCr) and bilirubin are used to calculate the MELD score. MELD score will be calculated using the original formula (pre-2016) which does not include serum sodium level. Original MELD Score = (0.957 x Ln(Serum Creatinine in mg/dL) + 0. 378 x Ln(Serum Bilirubin in mg/dL) + 1.120 x Ln (INR) + 0.643) x 10 Note: (1) If patient received two or more dialysis treatments within the prior 7 days, then the value for serum creatinine will be set to 4.0. (2) If any laboratory value is less than 1.0, the value will be set to 1.0 for the MELD score calculation, in order to avoid negative values resulting from taking the natural log of values less than 1.'}], 'secondaryOutcomes': [{'measure': 'Serum Cytokeratin 18 (M30)', 'timeFrame': 'Baseline (Screening or Day 1 Pre-dose), Day 7, Day 28', 'description': 'Analysis Population Description: Baseline was defined as the last non-missing value prior to study drug administration, at Screening or Day 1 Pre-dose.'}, {'measure': 'Serum Cytokeratin 18 (M65)', 'timeFrame': 'Baseline (Screening or Day 1 Pre-dose), Day 7, Day 28', 'description': 'Analysis Population Description: Baseline was defined as the last non-missing value prior to study drug administration, at Screening or Day 1 Pre-dose.'}, {'measure': 'International Normalized Ratio (INR) - Percent Change From Baseline', 'timeFrame': 'Baseline (Screening or Day 1 Pre-dose), Day 7, Day 28', 'description': 'ITT population. INR (international normalized ratio) is a standardized number based on the prothrombin time and calculated by the clinical lab. INR measures the time it takes for blood to clot in vitro and measures, among other things, liver synthetic function.'}, {'measure': 'Bilirubin - Percent Change From Baseline', 'timeFrame': 'Baseline (Screening or Day 1 Pre-dose), Day 7, Day 28', 'description': 'ITT population'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Alcoholic Hepatitis', 'acute alcoholic liver disease', 'progressive inflammatory liver injury', 'IV infusion'], 'conditions': ['Alcoholic Hepatitis']}, 'referencesModule': {'references': [{'pmid': '37011138', 'type': 'DERIVED', 'citation': 'Hassanein T, McClain CJ, Vatsalya V, Stein LL, Flamm SL, Martin P, Cave MC, Mitchell M Jr, Barton B, Nagy L, Szabo G, McCullough A, Dasarathy S, Shah J, Blevins C, Scott D, Krebs W, Brown JE, Lin W. Safety, Pharmacokinetics, and Efficacy Signals of Larsucosterol (DUR-928) in Alcohol-Associated Hepatitis. Am J Gastroenterol. 2024 Jan 1;119(1):107-115. doi: 10.14309/ajg.0000000000002275. Epub 2023 Apr 3.'}]}, 'descriptionModule': {'briefSummary': 'This is a research trial testing DUR-928 (an experimental medication). The purpose of this trial is to assess the dose related safety, Pharmacokinetics, and Pharmacodynamics of DUR 928 in patients with moderate and severe alcoholic hepatitis (AH).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Able to provide written informed consent (either from patient or patient's legally acceptable representative)\n2. Male or female patients 21 years of age or older with BMI ≥ 20 to ≤ 40 kg/m2\n3. Patients with alcoholic hepatitis defined as:\n\n 1. History of heavy alcohol abuse: \\> 40 g/day in females or \\> 60 g/day in males for a minimum period of 6 months, AND\n 2. Consumed alcohol within 12 weeks of entry into the study, AND\n 3. Serum bilirubin \\> 3 mg/dL AND AST \\> ALT, but less than 300 U/L AND\n 4. MELD score between 11-30, inclusive\n4. No evidence of active infection as determined by the investigator.\n5. Women of child-bearing potential must utilize appropriate birth control throughout the study duration.\n6. Male patients must agree to use a medically acceptable method of contraception/birth control throughout the study duration\n\nExclusion Criteria:\n\n1. Other or concomitant cause(s) of liver disease as a result of:\n\n 1. Autoimmune liver disease\n 2. Wilson disease\n 3. Vascular liver disease\n 4. Drug induced liver disease\n2. Co-infection with human immunodeficiency virus (HIV) or Hepatitis B\n3. Any active malignancies other than curatively treated skin cancer (basal cell or squamous cell carcinomas)\n4. If female, known pregnancy, or has a positive serum pregnancy test, or lactating/breastfeeding\n5. Serum creatinine \\> 2.5 mg/dL\n6. Patients who have had organ transplantation (such as liver, kidney, lung, heart, bone marrow, or stem cell etc.), other than cornea transplant\n7. Stage 3 or greater encephalopathy by West Haven criteria"}, 'identificationModule': {'nctId': 'NCT03432260', 'acronym': 'AH', 'briefTitle': 'A Research Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of DUR-928 in Patients With Alcoholic Hepatitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Durect'}, 'officialTitle': 'An Open- Label, Dose Escalation Study to Assess the Safety, Pharmacokinetics and Pharmacodynamic Signals of DUR-928 in Patients With Alcoholic Hepatitis', 'orgStudyIdInfo': {'id': 'C928-010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part A (Moderate AH) DUR-928 30 mg', 'description': 'Lowest dose of 3 dose escalation arms: 30mg, 90 mg and 150 mg', 'interventionNames': ['Drug: DUR-928 30 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Part A (Moderate AH) DUR-928 90 mg', 'description': 'Middle dose of 3 dose escalation arms: 30mg, 90 mg and 150 mg', 'interventionNames': ['Drug: DUR-928 90 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Part A (Moderate AH) DUR-928 150 mg', 'description': 'Highest dose of dose escalation arms: 30mg, 90 mg and 150 mg', 'interventionNames': ['Drug: DUR-928 150 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Part B (Severe AH) DUR-928 30 mg', 'description': 'Lowest dose of dose escalation arms: 30mg, 90 mg and 150 mg', 'interventionNames': ['Drug: DUR-928 30 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Part B (Severe AH) DUR-928 90 mg', 'description': 'Middle dose of dose escalation arms: 30mg, 90 mg and 150 mg', 'interventionNames': ['Drug: DUR-928 90 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Part B (Severe AH) DUR-928 150 mg', 'description': 'Highest dose of dose escalation arms: 30mg, 90 mg and 150 mg', 'interventionNames': ['Drug: DUR-928 150 mg']}], 'interventions': [{'name': 'DUR-928 30 mg', 'type': 'DRUG', 'description': 'Lowest dose of 3 dose escalation arms.', 'armGroupLabels': ['Part A (Moderate AH) DUR-928 30 mg', 'Part B (Severe AH) DUR-928 30 mg']}, {'name': 'DUR-928 90 mg', 'type': 'DRUG', 'description': 'Middle dose of 3 dose escalation arms.', 'armGroupLabels': ['Part A (Moderate AH) DUR-928 90 mg', 'Part B (Severe AH) DUR-928 90 mg']}, {'name': 'DUR-928 150 mg', 'type': 'DRUG', 'description': 'Highest dose of 3 dose escalation arms.', 'armGroupLabels': ['Part A (Moderate AH) DUR-928 150 mg', 'Part B (Severe AH) DUR-928 150 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92118', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'DURECT Study Site 0001', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'DURECT Study Site 007', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '30309', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'DURECT Study Site 0004', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'DURECT Study Site 0002', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'DURECT Study Site 008', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'DURECT Study Site 0005', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '78215', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'DURECT Study Site 006', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Robert Gordon, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'CTI Clinical Trial and Consulting Services'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Durect', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'CTI Clinical Trial and Consulting Services', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}