RECRUITINGPhase 4INTERVENTIONAL

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

Gene-guided N-acetyl Cysteine for Prophylaxis of Anti-tuberculous Drug- Induced Hepatitis: A Randomized Controlled Trial

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Patients aged 18 - 80 years old. - Newly diagnosed tuberculosis patients (both pulmonary and extrapulmonary). - Received standard anti-tuberculosis medication according to standard regimens (2HRZE/4HR, 2HRE/7HR). - Willing to participate in the research Who Should NOT Join This Trial: - Infected with HIV. - Severe liver dysfunction classified as Child-Pugh B or C. - Chronic untreated liver diseases such as hepatitis B or C, alcoholic liver disease. - Abnormal liver function tests including AST \> 1.5 times the upper limit of normal (48 U/L), ALT \> 1.5 times the upper limit of normal (55 U/L), ALP \> upper limit of normal (110 U/L), Total bilirubin \> upper limit of normal (1.2 mg/dL). - Diagnosed with cancer. - History of allergy to N-acetylcysteine (NAC). - Pregnant or breastfeeding. - Severe comorbidities such as CKD stage 4-5, chronic heart failure, severe pulmonary diseases (COPD, bronchiectasis). Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * Patients aged 18 - 80 years old. * Newly diagnosed tuberculosis patients (both pulmonary and extrapulmonary). * Received standard anti-tuberculosis medication according to standard regimens (2HRZE/4HR, 2HRE/7HR). * Willing to participate in the research Exclusion Criteria: * Infected with HIV. * Severe liver dysfunction classified as Child-Pugh B or C. * Chronic untreated liver diseases such as hepatitis B or C, alcoholic liver disease. * Abnormal liver function tests including AST \> 1.5 times the upper limit of normal (48 U/L), ALT \> 1.5 times the upper limit of normal (55 U/L), ALP \> upper limit of normal (110 U/L), Total bilirubin \> upper limit of normal (1.2 mg/dL). * Diagnosed with cancer. * History of allergy to N-acetylcysteine (NAC). * Pregnant or breastfeeding. * Severe comorbidities such as CKD stage 4-5, chronic heart failure, severe pulmonary diseases (COPD, bronchiectasis).

Treatments Being Tested

DRUG

N acetyl cysteine

1,200 mg/day for 8 weeks in NAT2 gene testing group and NAT2 gene phenotype is identified as slow acetylator.

Locations (1)

Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok Noi, Bangkok, Thailand