RecruitingPhase 4

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

Thailand116 participantsStarted 2024-03-12

Plain-language summary

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 can participate

Age range18 Years – 80 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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).

What they're measuring

Prevalence of hepatitis at 8 weeks

Timeframe: 8 weeks

Trial details

NCT IDNCT06484530

SponsorMahidol University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-09-18

Contact for this trial

Pongpot Namasae

66954408520 shy.pongpot@gmail.com