NCT06484530 Gene-guided N-acetyl Cysteine for Prophylaxis of Anti-tuberculous Drug- Induced Hepatitis
| NCT ID | NCT06484530 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Mahidol University |
| Condition | Tuberculosis (TB) |
| Study Type | INTERVENTIONAL |
| Enrollment | 116 participants |
| Start Date | 2024-03-12 |
| Primary Completion | 2024-09-18 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 116 participants in total. It began in 2024-03-12 with a primary completion date of 2024-09-18.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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).
Contact & Investigator
Supot Nimanong
PRINCIPAL INVESTIGATOR
Mahidol University
Frequently Asked Questions
Who can join the NCT06484530 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Tuberculosis (TB). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06484530 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06484530 currently recruiting?
Yes, NCT06484530 is actively recruiting participants. Contact the research team at shy.pongpot@gmail.com for enrollment information.
Where is the NCT06484530 trial being conducted?
This trial is being conducted at Bangkok Noi, Thailand.
Who is sponsoring the NCT06484530 clinical trial?
NCT06484530 is sponsored by Mahidol University. The principal investigator is Supot Nimanong at Mahidol University. The trial plans to enroll 116 participants.