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

NCT05738681 | Unknown Phase 2 DMC

• 1 other identifier: Si 1052/2020
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Tuberculosis; Drug Induced Liver Injury; Hepatitis

Keywords

Tuberculosis; DILI; Anti tuberculosis

Outcome Measures

Primary Outcomes (1)

• Prevalence of hepatitis at 8 weeks

  To study efficacy of NAC to prevent anti-TB drug induced liver injury. Outcome was measured events of hepatitis occurred at 8 weeks, compared between NAC versus controlled group, presented by total number and percent. Significant hepatitis was defined as elevated aspartate aminotransferase (AST) or alanine aminotransferase (ALT) more than 5 times of baseline levels.

  8 weeks

Secondary Outcomes (1)

• Prevalence of hepatitis among NAT2 slow acetylator patients

  8 weeks

Other Outcomes (2)

• Prevalence of hepatitis at 2 weeks

  2 weeks

• Prevalence of hepatitis at 24 weeks

  24 weeks

Study Arms (2)

NAC group

EXPERIMENTAL

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.

Drug: N acetyl cysteine

Non-NAC group

NO INTERVENTION

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.

Interventions

N acetyl cysteine DRUG

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

Also known as: Standard anti TB drug regimen

NAC group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Faculty of Medicine, Siriraj Hospital

Bangkok, 10700, Thailand

RECRUITING

MeSH Terms

Conditions

Tuberculosis; Chemical and Drug Induced Liver Injury; Hepatitis

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Liver Diseases; Digestive System Diseases; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Poisoning

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Supot Nimanong, MD

  Mahidol University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kittichai Samaithongcharoen, MD

CONTACT

0991494469; pao_kitichai@hotmail.com

Supot Supot, MD

CONTACT

0819134336; supotgi@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor, Faculty of Medicine, Siriraj Hospital Affiliation: Mahidol University

Model Details: 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.

Study Record Dates

• First Submitted: July 11, 2022
• First Posted: February 22, 2023
• Study Start: September 9, 2022
• Primary Completion: March 31, 2023
• Study Completion: May 31, 2023
• Last Updated: February 22, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)