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

• Status: Recruiting
• Trial end date: 2023-05-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Mahidol University
• Treatments: Acetylcysteine; N-monoacetylcystine

Criteria

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