NCT05738681

Efficacy of N-acetylcysteine to Prevent Anti-tuberculosis Drug-induced Liver Injury: A Randomized Controlled Trial

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 82 (estimated)
• Sponsor: Mahidol University · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Accepted

Summary

To determine the efficacy of NAC to prevent clinically significant anti-TB drugs induced liver injury (AT-DILI).

Detailed description

Tuberculosis is one of the most important infectious diseases and treatment related hepatitis from anti-TB drug was observed for 5-28%. Slow acetylator status in the N-acetyltransferase 2 (NAT2) genotype is a significant risk factor of anti-tuberculosis drug-induced liver injury (AT-DILI). We assessed the effect of N-acetylcysteine to prevent hepatitis from anti-TB drug in Thai population.

Conditions

• Tuberculosis
• Drug Induced Liver Injury
• Hepatitis

Interventions

Type	Name	Description
DRUG	N acetyl cysteine	N acetyl cysteine 1,200 mg/day for 8 weeks in NAC group

Timeline

• Start date: 2022-09-09
• Primary completion: 2023-03-31
• Completion: 2023-05-31
• First posted: 2023-02-22
• Last updated: 2023-02-22

Locations

1 site across 1 country: Thailand