Ignite Creation Date:
2025-12-24 @ 7:07 PM
Ignite Modification Date:
2026-06-10 @ 4:20 PM
Study NCT ID:
NCT02889757
Status:
UNKNOWN
Last Update Posted:
2016-09-13
First Post:
2016-08-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Protective Effect for Liver Organ in Patients With Anti-TB Drugs Using of Acetylcysteine (NAC)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014376', 'term': 'Tuberculosis'}], 'ancestors': [{'id': 'D009164', 'term': 'Mycobacterium Infections'}, {'id': 'D000193', 'term': 'Actinomycetales Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2019-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-09-09', 'studyFirstSubmitDate': '2016-08-31', 'studyFirstSubmitQcDate': '2016-09-06', 'lastUpdatePostDateStruct': {'date': '2016-09-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-09-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the incidence of DIH', 'timeFrame': 'during the 6 months treatment', 'description': 'the rate for'}], 'secondaryOutcomes': [{'measure': 'the incidence for other side effects', 'timeFrame': '6 months', 'description': 'side effects including GI upset, blurred vision, neuropathy, renal organ damage'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['tuberculosis', 'acetylcysteine', 'hepatotoxicity'], 'conditions': ['Protective Effect in TB-DIH', 'TB-DIH Means: Drug Induced Liver Function Abnormalities']}, 'descriptionModule': {'briefSummary': 'Animal studies have shown that INH-RIF-induced oxidative injury can be prevented by supporting the cellular antioxidant defense mechanism by N-acetylcysteine (NAC). However, there are few published data and large sample sizes regarding the protective effect of NAC against hepatotoxicty induced by anti-TB drugs in humans, to our knowledge.\n\nTherefore, the investigators designed a clinical trial with the aim to see whether NAC could protect against anti-TB drug-induced hepatotoxicity (DIH)', 'detailedDescription': 'Isoniazid (INH), rifampicin (RIF), and pyrazinamide (PZA), the first-line drugs used for tuberculosis (TB) chemotherapy, are associated with hepatotoxicity. A high rate of hepatotoxicity has been reported in some developing countries compared with advanced countries with a similar dose schedule. Sharifzadeh et al. reported an incidence of 27.7% in Iran. The reasons for this higher rate of hepatotoxicity are not completely clear. Ethnic variations, advanced age, female sex, alcoholism, underlying liver disease, acetylator phenotype, hepatitis B and C virus, HIV infection, extensive pulmonary parenchymal disease, and hypoalbuminemia have been observed to be the risk factors for the development of drug-induced hepatotoxicity (DIH) because of anti-TB treatment.\n\nThe mechanism of DIH induced by anti-TB treatment is not yet fully understood. Sodhi et al. proposed oxidative stress as one of the likely mechanisms for INH-RIF-induced hepatic injury. It is well established that by augmenting a cellular antioxidative defense system, especially nonprotein thiols, that is, glutathione (GSH), cells can be protected against oxidative injuries produced by various drugs and chemicals.\n\nThe study will be performed with randomized trial for assessment and protective effects over liver function in patients receiving anti-TB agents and using NAC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. new diagnosed to have tuberculosis\n2. age \\>20 years -\n\nExclusion Criteria:\n\n1. acute hepatitis in a previous one year\n2. TB drugs induced urticaria or Steven-Johnson syndrome\n3. life less than one year due to advanced cancer status\n4. non-tuberculosis mycobacteria，NTM patients\n5. HIV patients\n6. patients can not cooperate\n7. Allergic reaction for NAC'}, 'identificationModule': {'nctId': 'NCT02889757', 'briefTitle': 'The Protective Effect for Liver Organ in Patients With Anti-TB Drugs Using of Acetylcysteine (NAC)', 'organization': {'class': 'OTHER', 'fullName': 'Far Eastern Memorial Hospital'}, 'officialTitle': 'the Safety and Effect in TB Patients With NAC', 'orgStudyIdInfo': {'id': 'T-6621'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NAC 1200 mg', 'description': 'patients with add NAC (600) 1# bid use per day during the study period', 'interventionNames': ['Drug: Acteylcysteine']}, {'type': 'EXPERIMENTAL', 'label': 'NAC 2400 mg', 'description': 'patients with add NAC (600) 2# bid use per day during the study period', 'interventionNames': ['Drug: Acteylcysteine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'NAC 0 mg', 'description': 'patients with add NAC (600) 0# (placebo) use per day during the study period', 'interventionNames': ['Drug: Acteylcysteine']}], 'interventions': [{'name': 'Acteylcysteine', 'type': 'DRUG', 'description': 'randomized into three arms', 'armGroupLabels': ['NAC 0 mg', 'NAC 1200 mg', 'NAC 2400 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '886', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Far Eastern Memorial Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Far Eastern Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Shih-Lung Cheng', 'investigatorAffiliation': 'Far Eastern Memorial Hospital'}}}}