Efficacy of N-acetylcysteine to Prevent Anti-tuberculosis Drug-induced Liver Injury: A Randomized Controlled Trial

Si 1052/2020

To determine the efficacy of NAC to prevent clinically significant anti-TB drugs induced liver injury (AT-DILI).

2022-09-09

2023-03-31

2023-05-31

Recruiting

Early phase I

82

Inclusion Criteria: * Newly diagnosed TB * Received standard dose of anti-TB drugs regimen (National Tuberculosis Control Programme guideline Thailand 2018) * Aged ≥18 years * Informed consent Exclusion Criteria: * Previous TB infection or MDR TB * TB liver * Allergy to NAC * Abnormal baseline LFT * (AST or ALT\>2.5 times UNL, ALP\> 2 times UNL, TB\> 1.5 mg/dl) * Chronic hepatitis B, C infection * Decompensated cirrhosis * HIV infection * Active malignancy * Pregnancy or lactation * Severe co-morbidity i.e. severe heart diseases, severe lung diseases, ESRD

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Tuberculosis patients who had standard regimen treatment, non-HIV, no severe co-morbidity, no chronic hepatitis B or C were randomized to using NAC-long 1,200 mg/day for 8 weeks (NAC long group) or using anti-TB alone (non-NAC group). Genetic test, CBC, Cr, coagulogram were assessed at baseline. LFT were assessed at baseline, 2 weeks, 8 weeks and 24 weeks.', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 82, 'type': 'ESTIMATED'}}

2023-02-22