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

NCT06484530 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 116

Last updated 2024-07-03

No results posted yet for this study

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.

Conditions

  • Tuberculosis (TB)
  • Isoniazid Toxicity
  • Rifampicin Toxicity
  • Pyrazinamide Adverse Reaction
  • Ethambutol Toxicity
  • NAT2 Slow Acetylator Status
  • NAT2 Rapid Acetylator Status
  • NAT2 Polymorphism
  • N-Acetylcysteine

Interventions

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.

Sponsors & Collaborators

  • Mahidol University

    lead OTHER

Principal Investigators

  • Supot Nimanong · Mahidol University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-12
Primary Completion
2024-09-18
Completion
2024-09-18

Countries

  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06484530 on ClinicalTrials.gov