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Study identifier: NCT06484530 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

Gene-guided N-acetyl Cysteine for Prophylaxis of Anti-tuberculous Drug- Induced Hepatitis

Condition: Tuberculosis (TB) · Isoniazid Toxicity · Rifampicin Toxicity  ·  Sponsor: Mahidol University

PhasePhase 4
Planned participants116
Who can joinAll sexes, 18 Years to 80 Years
Healthy volunteersNo

About this study

Tuberculosis (TB) remains a significant public health concern in Thailand and globally, especially in tropical regions, with pulmonary TB being predominant. Besides affecting the lungs, TB can also impact extrapulmonary organs. Standard TB treatment involves a combination of drugs administered for at least 6 months, but it can cause adverse effects such as hepatitis. Hepatotoxicity, occurring in 20-60% of patients, is commonly linked to isoniazid, rifampicin, and pyrazinamide. Slow acetylators of the NAT2 gene are particularly susceptible. Previous research suggests N-acetylcysteine (NAC) may mitigate hepatotoxicity, especially among slow acetylators. A recent study by Kittichai Samaithongcharoen and team showed that NAC reduced hepatotoxicity incidence significantly among slow acetylators. This underscores the potential of NAC in preventing drug-induced hepatotoxicity in TB treatment, warranting further investigation against standard treatment protocols.

This description comes directly from the study's public registry record.

Talk to the study team

Pongpot Namasae  ·  66954408520  ·  shy.pongpot@gmail.com

Supot Nimanong  ·  66819134336  ·  supotgi@gmail.com

Always discuss trial participation with your own doctor first.

Locations (1)

Faculty of Medicine Siriraj Hospital, Mahidol UniversityBangkok Noi, Bangkok, ThailandRecruiting

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Source record: clinicaltrials.gov/study/NCT06484530