A Multicenter- Randomized Controlled Trial of N-acetylcysteine Effectiveness for The Prevention of Anti-Tuberculosis Drug-induced Liver Injury (NAC-TB-DILI trial)

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

TCTR

Registry ID

TCTR20260312003

Enrollment

200

Registered

2026-03-12

Start date

2026-04-01

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thai patients aged 18 years or older who was diagnosed with tuberculosis based on sputum or tissue testing by Xpert MTB/RIF Ultra, tuberculosis culture, or PCR for tuberculosis, and receiving standard anti-tuberculosis treatment with HRZE or HRE. tuberculosis, N-acetylcysteine, HRZE, Drug-induced liver injury

Interventions

Patients in the experimental group will be prescribed oral NAC 600 mg, one tablet in the morning and one tablet in the evening, for a duration of 4 weeks. ,Patients in the control group will receive s

Experimental Drug,No Intervention No treatment

N-acetylcysteiene,Standard of care

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Thai patients aged 18 years or older,2.Diagnosed with tuberculosis based on sputum or tissue testing by Xpert MTB/RIF Ultra, tuberculosis culture, or PCR for tuberculosis, and receiving standard anti-tuberculosis treatment with HRZE or HRE,3.Not currently receiving treatment for active tuberculosis or latent tuberculosis before study enrollment, or having received HRZE or HRE for no more than 1 week from treatment initiation,4.Willing to participate voluntarily in the study and having provided written informed consent.

Exclusion criteria

Exclusion criteria: 1.Pregnant women,2.Known allergy to N-acetylcysteine,3.Patients or their relatives who do not provide consent for study participation,4.Patients with Child-Pugh class C cirrhosis,5.Patients who are expected to die within 48 hours after study enrollment.

Design outcomes

Primary

Measure	Time frame
anti-tuberculosis drug-induced liver injury (AT-DILI) 4 weeks after allocation Hy s law criteria	—

Secondary

Measure	Time frame
anti-tuberculosis drug-induced liver injury (AT-DILI) 2,4 weeks after allocation Hy s law criteria,liver function test 2,4,8 weeks after allocation difference,Safety criteria 2,4,8 weeks after allocation DAIDS Version 2.1 ,DILI risk factor 2,4,8 weeks risk factor as evaluation,duration until DILI 2,4,8 weeks after allocation Hy s law criteria	—

Countries

Thailand

Contacts

Public Contactsasiwan atithammarak

King chulalongkorn memorial hospital

sasiwan_43@hotmail.com0922494888

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026