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

Mahidol University

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Drug Induced Liver Injury; Tuberculosis; Hepatitis

Treatments: Drug: N acetyl cysteine

Study type: Interventional

Funder types: Other

Identifiers

NCT05738681

Si 1052/2020

Details and patient eligibility

About

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

Full 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.

Enrollment: 82 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Newly diagnosed TB
• Received standard dose of anti-TB drugs regimen (National Tuberculosis Control Programme guideline Thailand 2018)
• Aged ≥18 years
• Informed consent

Exclusion criteria

• Previous TB infection or MDR TB
• TB liver
• Allergy to NAC
• Abnormal baseline LFT
• (AST or ALT>2.5 times UNL, ALP> 2 times UNL, TB> 1.5 mg/dl)
• Chronic hepatitis B, C infection
• Decompensated cirrhosis
• HIV infection
• Active malignancy
• Pregnancy or lactation
• Severe co-morbidity i.e. severe heart diseases, severe lung diseases, ESRD

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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82 participants in 2 patient groups

NAC group

Experimental group

Description:

Tuberculosis patients who had standard regimen treatment, non-HIV, no severe co-morbidity, no chronic hepatitis B or C using NAC-long 1,200 mg/day for 8 weeks (NAC long group). Genetic test (acetylator status of NAT2), CBC, Cr, coagulogram were assessed at baseline. LFT were assessed at baseline, 2 weeks, 8 weeks and 24 weeks.

Treatment:

Drug: N acetyl cysteine

Non-NAC group

No Intervention group

Description:

Tuberculosis patients who had standard regimen treatment, non-HIV, no severe co-morbidity, no chronic hepatitis B or C were using anti-TB alone (non-NAC group). Genetic test (Acetylator status of NAT2), CBC, Cr, coagulogram were assessed at baseline. LFT were assessed at baseline, 2 weeks, 8 weeks and 24 weeks.