Gene-guided N-acetyl Cysteine to prevent liver damage from TB drugs
Gene-guided N-acetyl Cysteine for Prophylaxis of Anti-tuberculous Drug- Induced Hepatitis: A Randomized Controlled Trial
This study is testing if N-acetylcysteine can help protect the livers of newly diagnosed tuberculosis patients who are at risk of liver damage from their TB medications.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 116 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Mahidol University Academic / other |
| Locations | 1 site (Bangkok Noi, Bangkok) |
| Trial ID | NCT06484530 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of N-acetylcysteine (NAC) to prevent hepatotoxicity in patients undergoing treatment for tuberculosis (TB). It focuses on newly diagnosed TB patients who are at risk of liver damage due to standard anti-TB medications, particularly those with the NAT2 slow acetylator phenotype. The study aims to determine if NAC can significantly reduce the incidence of drug-induced hepatitis, which affects a substantial percentage of TB patients. Participants will receive standard TB treatment alongside NAC to assess its protective effects on liver function.
Who should consider this trial
Good fit: Ideal candidates for this study are newly diagnosed tuberculosis patients aged 18 to 80 who are starting standard anti-TB therapy.
Not a fit: Patients with severe liver dysfunction, chronic liver diseases, or those infected with HIV may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of liver damage in TB patients, improving treatment adherence and outcomes.
How similar studies have performed: Previous studies have shown promising results with NAC in reducing hepatotoxicity among slow acetylators, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Bangkok Noi, Bangkok
- Faculty of Medicine Siriraj Hospital, Mahidol University — Bangkok Noi, Bangkok, Thailand (Recruiting)
Study contacts
- Principal investigator: Supot Nimanong — Mahidol University
- Study coordinator: Pongpot Namasae
- Email: shy.pongpot@gmail.com
- Phone: 66954408520
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.