Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2026-02-25 @ 11:05 PM
Study NCT ID:
NCT02182167
Status:
COMPLETED
Last Update Posted:
2019-02-19
First Post:
2014-06-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Trial Of Intravenous N-Acetylcysteine In The Management Of Antituberculous Drug-Induced Hepatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D056486', 'term': 'Chemical and Drug Induced Liver Injury'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D064420', 'term': 'Drug-Related Side Effects and Adverse Reactions'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D011041', 'term': 'Poisoning'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000111', 'term': 'Acetylcysteine'}, {'id': 'D014867', 'term': 'Water'}], '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'}, {'id': 'D006878', 'term': 'Hydroxides'}, {'id': 'D000468', 'term': 'Alkalies'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D000838', 'term': 'Anions'}, {'id': 'D007477', 'term': 'Ions'}, {'id': 'D004573', 'term': 'Electrolytes'}, {'id': 'D010087', 'term': 'Oxides'}, {'id': 'D017601', 'term': 'Oxygen Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 102}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2019-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-18', 'studyFirstSubmitDate': '2014-06-18', 'studyFirstSubmitQcDate': '2014-07-07', 'lastUpdatePostDateStruct': {'date': '2019-02-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-07-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Biomarkers', 'description': 'To store blood, urine and biopsy specimens (if biopsies were taken as part of patient management),bank serum, to enable us to conduct future sub studies exploring mechanisms, predictors and biomarkers of TB DIH, genetic associations with TB DIH and improved diagnostic strategies'}], 'primaryOutcomes': [{'measure': 'ALT normalisation', 'timeFrame': 'up to 8 weeks', 'description': 'To determine the effect of IV NAC on the time to normalization of liver function in patients with TB DIH'}], 'secondaryOutcomes': [{'measure': 'Duration of hospitalization', 'timeFrame': 'up to 8 weeks', 'description': 'To determine the effect of IV NAC on duration of hospitalization'}, {'measure': 'Recovery from liver failure', 'timeFrame': 'up to 8 weeks', 'description': 'To determine the effect of IV NAC on the rate of recovery from liver failure'}, {'measure': 'All-cause mortality', 'timeFrame': 'up to 8 weeks', 'description': 'To determine the effect of IV NAC on all-cause mortality in patients with TB DIH'}, {'measure': 'Adverse Events', 'timeFrame': 'up to 8 weeks', 'description': 'To determine the adverse event profile of IV NAC when administered to patients with TB DIH'}, {'measure': 'TB Drug Rechallenge', 'timeFrame': 'up to 8 weeks', 'description': 'To determine the effect of IV NAC on success of TB drug rechallenge.'}, {'measure': 'Rechallenge duration', 'timeFrame': 'up to 8 weeks', 'description': 'To determine the effect of IV NAC on duration of rechallenge'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Drug Induced Hepatitis (DIH)', 'Toxic Liver', 'Drug Induced Liver Injury (DILI)'], 'conditions': ['Drug-Induced Liver Injury']}, 'descriptionModule': {'briefSummary': 'We will conduct a randomized placebo controlled trial to determine whether administration of intravenous (IV) NAC to participants with TB DIH, in dosages similar to that used in paracetamol poisoning, can improve recovery from hepatotoxicity.', 'detailedDescription': 'South Africa has a huge tuberculosis (TB) disease burden, with 948 per 100 000 people diagnosed with TB in 2008. TB drug induced hepatitis (DIH) is a common adverse effect of TB therapy that causes significant patient morbidity and prolonged hospital stays. N-Acetylcysteine (NAC) has been extensively studied and used for many years in the treatment of paracetamol-induced hepatotoxicity, with good evidence of efficacy and safety. NAC has also been used in other forms of liver injury and drug toxicity. It has not previously been used in the management of TB DIH.\n\nWe will screen all patients with clinical hepatitis on TB treatment admitted to New Somerset and Groote Schuur hospitals and aim to recruit 100 participants over 3 years. We will randomise 50 participants to receive an IV loading dose of 150mg/kg of NAC over 60 minutes followed by 50mg/kg IV over 4 hours by continuous infusion and finally 100mg/kg IV over 16 hours. Fifty participants will be randomised to receive placebo. The primary outcome will be time to normalisation of liver function (ALT\\<100). We will also determine the effect of NAC on duration of hospitalization, rate of recovery from liver failure, all cause mortality, and describe adverse effects of IV NAC in this patient population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults \\> 18 years old\n* Diagnosed with pulmonary or extrapulmonary tuberculosis based on symptoms, radiological features and/or laboratory evidence.\n* On first line antituberculous therapy\n* Diagnosed with TB DIH\n\nExclusion Criteria:\n\n* Patients with a diagnosis of acute viral hepatitis based on a positive anti-HAV, IgM, anti- HBcIgM, or confirmed hepatitis C infection\n* Patients known to be asthmatic'}, 'identificationModule': {'nctId': 'NCT02182167', 'acronym': 'NAC in TB DIH', 'briefTitle': 'A Trial Of Intravenous N-Acetylcysteine In The Management Of Antituberculous Drug-Induced Hepatitis', 'organization': {'class': 'OTHER', 'fullName': 'University of Cape Town'}, 'officialTitle': 'A Randomised Controlled Trial of Intravenous N-acetylcysteine in the Management of Antituberculous Drug-induced Hepatitis', 'orgStudyIdInfo': {'id': '20130808'}, 'secondaryIdInfos': [{'id': 'DOH-27-0414-4719.', 'type': 'REGISTRY', 'domain': 'SANCTR'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IV NAC', 'description': 'Participants will receive IV N-acetylcysteine or placebo. The dosing regimen is based on the regimens used in paracetamol poisoning .\n\nInitial dose: 150 mg/kg body mass of N-acetylcysteine/WFI infused in 200 mL of 5% dextrose intravenously over 60 minutes, followed by continuous infusion: 50 mg/kg body mass in 500 mL of 5% dextrose over next 4 hours, followed by 100 mg/kg body mass in 1 litre of 5% dextrose over 16 hours.', 'interventionNames': ['Drug: IV N-acetylcysteine (NAC)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Water', 'interventionNames': ['Drug: Water']}], 'interventions': [{'name': 'IV N-acetylcysteine (NAC)', 'type': 'DRUG', 'otherNames': ['Paradote'], 'armGroupLabels': ['IV NAC']}, {'name': 'Water', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7925', 'city': 'Cape Town', 'state': 'Western Province', 'country': 'South Africa', 'facility': 'Groote Schuur Hospital', 'geoPoint': {'lat': -33.92584, 'lon': 18.42322}}, {'zip': '8005', 'city': 'Cape Town', 'state': 'Western Province', 'country': 'South Africa', 'facility': 'New Somerset Hospital', 'geoPoint': {'lat': -33.92584, 'lon': 18.42322}}], 'overallOfficials': [{'name': 'Karen Cohen', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Cape Town'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Cape Town', 'class': 'OTHER'}, 'collaborators': [{'name': 'Medical Research Council, South Africa', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr Karen Cohen', 'investigatorFullName': 'Dr Karen Cohen', 'investigatorAffiliation': 'University of Cape Town'}}}}