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

Tuberculosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05738681
• Other study ID #: Si 1052/2020
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: September 9, 2022
• Est. completion date: May 31, 2023

Study information

• Verified date: February 2023
• Source: Mahidol University
• Contact: Kittichai Samaithongcharoen, MD
• Phone: 0991494469
• Email: pao_kitichai[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 82
• Est. completion date: May 31, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Chemical and Drug Induced Liver Injury
• Drug Induced Liver Injury
• Hepatitis
• Tuberculosis
• Wounds and Injuries

Intervention

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

Locations

Country	Name	City	State
Thailand	Faculty of Medicine, Siriraj Hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Prevalence of hepatitis at 2 weeks	Outcome was measured events of hepatitis occurred at 2 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.	2 weeks
Other	Prevalence of hepatitis at 24 weeks	Outcome was measured events of hepatitis occurred at 24 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.	24 weeks
Primary	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	Prevalence of hepatitis among NAT2 slow acetylator patients	To study efficacy of NAC to prevent anti-TB drug induced liver injury among NAT2 slow acetylator patients.; Outcome was measured events of hepatitis occurred at 8 weeks among NAT2 slow acetylator patients 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