Ignite Creation Date:
2025-12-26 @ 12:18 PM
Ignite Modification Date:
2026-01-13 @ 9:20 AM
Study NCT ID:
NCT03069300
Status:
UNKNOWN
Last Update Posted:
2021-11-09
First Post:
2017-02-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
N-ACetylcysteine to Reduce Infection and Mortality for Alcoholic Hepatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-08-09', 'releaseDate': '2024-02-27'}], 'estimatedResultsFirstSubmitDate': '2024-02-27'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D006519', 'term': 'Hepatitis, Alcoholic'}, {'id': 'D007239', 'term': 'Infections'}], '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': 'D000111', 'term': 'Acetylcysteine'}], 'ancestors': [{'id': 'D003545', 'term': 'Cysteine'}, {'id': 'D000603', 'term': 'Amino Acids, Sulfur'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'randomized controlled trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 42}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-11-08', 'studyFirstSubmitDate': '2017-02-28', 'studyFirstSubmitQcDate': '2017-02-28', 'lastUpdatePostDateStruct': {'date': '2021-11-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement in monocyte oxidative burst', 'timeFrame': '24 hours'}, {'measure': 'Improvement in ex vivo monocyte oxidative burst', 'timeFrame': '5 days'}], 'secondaryOutcomes': [{'measure': 'Proportion of patients infected', 'timeFrame': '28 days', 'description': 'Infection will be defined in two ways: i. by new/change in intravenous antibiotic prescription and ii. published clinical and microbiological criteria for infection in the setting of liver disease'}, {'measure': 'Proportion of patients infected', 'timeFrame': '90 days', 'description': 'Infection will be defined in two ways: i. by new/change in intravenous antibiotic prescription and ii. published clinical and microbiological criteria for infection in the setting of liver disease'}, {'measure': 'Death', 'timeFrame': '28 days'}, {'measure': 'Death', 'timeFrame': '90 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Alcoholic Hepatitis', 'Infection']}, 'referencesModule': {'references': [{'pmid': '22070475', 'type': 'BACKGROUND', 'citation': 'Nguyen-Khac E, Thevenot T, Piquet MA, Benferhat S, Goria O, Chatelain D, Tramier B, Dewaele F, Ghrib S, Rudler M, Carbonell N, Tossou H, Bental A, Bernard-Chabert B, Dupas JL; AAH-NAC Study Group. Glucocorticoids plus N-acetylcysteine in severe alcoholic hepatitis. N Engl J Med. 2011 Nov 10;365(19):1781-9. doi: 10.1056/NEJMoa1101214.'}, {'pmid': '26860769', 'type': 'RESULT', 'citation': "Vergis N, Khamri W, Beale K, Sadiq F, Aletrari MO, Moore C, Atkinson SR, Bernsmeier C, Possamai LA, Petts G, Ryan JM, Abeles RD, James S, Foxton M, Hogan B, Foster GR, O'Brien AJ, Ma Y, Shawcross DL, Wendon JA, Antoniades CG, Thursz MR. Defective monocyte oxidative burst predicts infection in alcoholic hepatitis and is associated with reduced expression of NADPH oxidase. Gut. 2017 Mar;66(3):519-529. doi: 10.1136/gutjnl-2015-310378. Epub 2016 Feb 9."}]}, 'descriptionModule': {'briefSummary': 'Recent data have suggested that monocyte oxidative burst defect is associated with the development of infection in patients with severe alcoholic hepatitis. One report found reduced 28 day mortality in patients treated with N-acetylcysteine combined with prednisolone when compared to prednisolone alone. The current study seeks to reveal whether the mechanism by which NAC reduces susceptibility to infection is through improvement of phagocyte oxidative burst.', 'detailedDescription': 'Randomised controlled trial, open label.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Aged 18 years or older\n* Clinical alcoholic hepatitis:\n\n * Serum bilirubin \\>80umol/L\n * History of alcohol excess (\\>80g/day male, \\>60g/day female)\n * Less than 4 weeks since admission to hospital\n * Maddrey's discriminant function (DF) \\>32\n * Informed consent\n\nExclusion Criteria:\n\n* Alcohol abstinence of \\>6 weeks prior to randomisation\n* Duration of jaundice \\>3 months\n* Other causes of liver disease including:\n\n * Evidence of viral hepatitis (hepatitis B or C)\n * Biliary obstruction\n * Hepatocellular carcinoma\n* Evidence of current malignancy (except non-melanotic skin cancer)\n* Previous entry into the study\n* Patients with known hypersensitivity or previous reactions to NAC\n* Pregnant or lactating women"}, 'identificationModule': {'nctId': 'NCT03069300', 'acronym': 'NACAH', 'briefTitle': 'N-ACetylcysteine to Reduce Infection and Mortality for Alcoholic Hepatitis', 'organization': {'class': 'OTHER', 'fullName': 'Imperial College London'}, 'officialTitle': 'The Mechanism of Action of N-acetylcysteine for Reducing the Risk of Infection in Alcoholic Hepatitis', 'orgStudyIdInfo': {'id': '14SM2383'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'prednisolone+NAC', 'description': '40mg prednisolone once a day for 28 days and 30 minutes of intravenous NAC at 150mg/kg in 250ml 5% dextrose solution followed by 4 hours of intravenous NAC at 50mg/kg in 500ml 5% dextrose solution, followed by 16 hours of intravenous NAC at 100 mg/kg in 1000ml 5% dextrose solution, followed by 4 days of intravenous NAC at 100mg/kg/day in 1000ml 5% dextrose solution', 'interventionNames': ['Drug: N-acetyl cysteine (NAC)']}, {'type': 'NO_INTERVENTION', 'label': 'prednisolone', 'description': '40mg prednisolone for 28 days'}], 'interventions': [{'name': 'N-acetyl cysteine (NAC)', 'type': 'DRUG', 'otherNames': ['NAC'], 'armGroupLabels': ['prednisolone+NAC']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'W2 1NY', 'city': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Nikhil Vergis, PhD', 'role': 'CONTACT'}], 'facility': "St Mary's Hospital, Imperial College", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'centralContacts': [{'name': 'Nikhil Vergis, PhD', 'role': 'CONTACT', 'email': 'nvergis@ic.ac.uk'}, {'name': 'Mark Thursz, MD', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Mark Thursz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Imperial College London'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'contact investigators'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Imperial College London', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2024-02-27', 'type': 'RELEASE'}, {'date': '2024-08-09', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Imperial College London'}}}}