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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-09

Study Completion Date

2023-05-31

Brief Summary

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

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Detailed Description

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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

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Tuberculosis Drug Induced Liver Injury Hepatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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NAC group

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.

Group Type EXPERIMENTAL

N acetyl cysteine

Intervention Type DRUG

N acetyl cysteine 1,200 mg/day for 8 weeks in NAC group

Non-NAC group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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N acetyl cysteine

N acetyl cysteine 1,200 mg/day for 8 weeks in NAC group

Intervention Type DRUG

Other Intervention Names

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Standard anti TB drug regimen

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes