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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Thailand
Faculty of Medicine Siriraj Hospital, Mahidol University
RECRUITING
Bangkok Noi
Contact Information
Primary
Pongpot Namasae
shy.pongpot@gmail.com
66954408520
Backup
Supot Nimanong
supotgi@gmail.com
66819134336
Time Frame
Start Date: 2024-03-12
Estimated Completion Date: 2024-09-18
Participants
Target number of participants: 116
Treatments
Experimental: NAT2 gene testing group
Tuberculosis patients will undergo NAT2 gene testing before starting anti-tuberculosis medication. If the NAT2 gene phenotype is identified as slow acetylator, the patient will receive NAC medication at a dose of 600 mg twice daily for 8 weeks in addition to anti-tuberculosis medication. If the NAT2 gene phenotype is identified as rapid or intermediate acetylator, the patient will receive only anti-tuberculosis medication.
No_intervention: Non NAT2 gene testing
Tuberculosis patients will receive standard anti-tuberculosis medication without NAT2 gene testing.
Related Therapeutic Areas
Sponsors
Leads: Mahidol University

This content was sourced from clinicaltrials.gov