Ignite Creation Date:
2025-12-24 @ 2:25 PM
Ignite Modification Date:
2026-03-01 @ 12:04 PM
Study NCT ID:
NCT02776059
Status:
COMPLETED
Last Update Posted:
2021-09-29
First Post:
2016-05-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pegfilgrastim in Patients With Alcoholic Hepatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006519', 'term': 'Hepatitis, Alcoholic'}, {'id': 'D008104', 'term': 'Liver Cirrhosis, 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'}, {'id': 'D008103', 'term': 'Liver Cirrhosis'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}, {'id': 'C455861', 'term': 'pegfilgrastim'}, {'id': 'D011239', 'term': 'Prednisolone'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2021-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-23', 'studyFirstSubmitDate': '2016-05-10', 'studyFirstSubmitQcDate': '2016-05-15', 'lastUpdatePostDateStruct': {'date': '2021-09-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse events, especially infection and renal failure, Change in MELD Score and DF between Day 1 and Day 29, Lille score (at Day 8)', 'timeFrame': 'Day 1, Day 8, Day 29, and Day 90', 'description': 'The primary outcome will be survival at Day 90. Assuming a fixed sample size of 70 patients (35 per arm), a one-sided z-test will have 81.6% power to detect a 25% improvement in survival proportions between arms, with survival in the standard of care arm at 65%.'}], 'secondaryOutcomes': [{'measure': 'adverse events', 'timeFrame': '24 weeks', 'description': 'adverse events through Week 24'}, {'measure': 'Liver function', 'timeFrame': 'Day 29', 'description': 'Change in MELD and Maddrey DF during first 4 weeks'}, {'measure': 'liver function', 'timeFrame': 'Day 8', 'description': 'Change in Lille score'}, {'measure': 'Survival', 'timeFrame': 'at Day 90', 'description': 'survival at Day 90'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['survival', 'pegfilgrastim', 'cirrhosis, alcoholic'], 'conditions': ['Alcoholic Hepatitis']}, 'referencesModule': {'references': [{'pmid': '36267499', 'type': 'DERIVED', 'citation': 'Tayek JA, Stolz AA, Nguyen DV, Fleischman MW, Donovan JA, Alcorn JM, Chao DC, Asghar A, Morgan TR; Southern California Alcoholic Hepatitis (SCAH) Consortium. A phase II, multicenter, open-label, randomized trial of pegfilgrastim for patients with alcohol-associated hepatitis. EClinicalMedicine. 2022 Oct 12;54:101689. doi: 10.1016/j.eclinm.2022.101689. eCollection 2022 Dec.'}]}, 'descriptionModule': {'briefSummary': 'This is a multi-center, prospective, randomized trial of standard of care vs. standard of care + pegfilgrastim (Neulasta®) among patients with a clinical diagnosis of alcoholic hepatitis and DF≥32.', 'detailedDescription': "Standard of care treatment will be with either prednisolone 40 mg/day for 28 days or pentoxifylline 400 mg TID for 28 days. The patient's physician will decide the standard of care treatment the patient will receive. Patients will be randomized (1:1) to receive either no additional drug treatment (SOC group) or to receive a pegfilgrastim (Neulasta®, 6 mg) SQ.\n\nPatients will be seen in-person at screening, randomization (Day 1), Day 8, Day 29, Week 12, and Week 24. Safety examination and blood tests will be performed. In addition, biological specimens will be saved for research purposes at these time points.\n\nTotal duration of patient participation is 24 weeks."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* A clinical diagnosis of alcoholic hepatitis with Maddrey's discriminant function score ≥32. Age 18 years or older.\n\nExclusion Criteria:\n\n* Renal failure (creatinine \\>2.0 mg/dl)\n* Bilirubin \\<5 mg/dL\n* uncontrolled recent upper gastrointestinal bleeding\n* Known HIV infection\n* Uncontrolled infection, or pregnant."}, 'identificationModule': {'nctId': 'NCT02776059', 'briefTitle': 'Pegfilgrastim in Patients With Alcoholic Hepatitis', 'organization': {'class': 'OTHER', 'fullName': 'Southern California Institute for Research and Education'}, 'officialTitle': 'A Phase II, Multicenter, Randomized, Open-label Study to Investigate the Safety and Efficacy of Pegfilgrastim (Neulasta®) in Patients With Alcoholic Hepatitis', 'orgStudyIdInfo': {'id': 'SCAH Consortium- AH Treatment'}, 'secondaryIdInfos': [{'id': '5U01AA021886', 'link': 'https://reporter.nih.gov/quickSearch/5U01AA021886', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'prednisolone or pentoxifylline + pegfiltrastim', 'description': 'prednisolone or pentoxifylline for 28 days PO plus pegfilgrastim subcutaneous weekly shot', 'interventionNames': ['Drug: Standard of care + pegfiltrastim']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'prednisolone or pentoxifylline', 'description': 'prednisolone or pentoxifylline for 28 days', 'interventionNames': ['Drug: Standard of care']}], 'interventions': [{'name': 'Standard of care + pegfiltrastim', 'type': 'DRUG', 'otherNames': ['Neulasta®'], 'description': 'prednisolone or pentoxifyline orally for 28 days + pegfilgrastim (Neulasta®) 6 mg in 0.6 mL SQ', 'armGroupLabels': ['prednisolone or pentoxifylline + pegfiltrastim']}, {'name': 'Standard of care', 'type': 'DRUG', 'otherNames': ['prednisolone or pentoxifyline'], 'description': 'Oral prednisolone or pentoxifyline for 28 days only', 'armGroupLabels': ['prednisolone or pentoxifylline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92357', 'city': 'Loma Linda', 'state': 'California', 'country': 'United States', 'facility': 'VA Loma Linda Healthcare System', 'geoPoint': {'lat': 34.04835, 'lon': -117.26115}}, {'zip': '98022', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'VA Long Beach Healthcare System', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '90089', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'LAC-USC Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90502', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'Harbor-UCLA Medical Center', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '87108', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'New Mexico VA Health Care System', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}], 'overallOfficials': [{'name': 'Timothy Morgan, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'VA Long Beach Healthcare System'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': "Patients' coded data will be shared ."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Timothy Morgan, MD', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Alcohol Abuse and Alcoholism (NIAAA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Chief of Hepatology', 'investigatorFullName': 'Timothy Morgan, MD', 'investigatorAffiliation': 'Southern California Institute for Research and Education'}}}}