Anti-tuberculosis drug-induced liver injury (ATDILI) in patients receiving standard first-line anti-tuberculosis therapy with isoniazid, rifampicin, pyrazinamide, and ethambutol. Drug-induced liver injury Hepatotoxicity Tuberculosis Ursodeoxycholic acid
Conditions
Interventions
Participants will receive Ursodeoxycholic Acid (UDCA) at a dose of 13 to 15 mg/kg/day, administered orally in two or three divided doses according to body weight adjustment, for a total duration of 8
Active Comparator Drug,Placebo Comparator Drug
UDCA Group,Placebo Group
Sponsors
Faculty of Medicine, Research Grant , Khon Kaen University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Tuberculosis cases ,2.Planned to start standard first-line anti-tuberculosis treatment (isoniazid, rifampicin, pyrazinamide, and ethambutol,3.Normal baseline liver function tests
Exclusion criteria
Exclusion criteria: 1.History of chronic liver disease, such as cirrhosis, chronic hepatitis B or C infection, autoimmune hepatitis, or alcoholic liver disease,2.Alcohol consumption <= 140 g/week for females or <=210 g/week for males,3.Current use of hepatotoxic medications, herbal remedies, or dietary supplements known to affect liver function,4.Known history of hypersensitivity or contraindication to UDCA,5.Pregnant or breastfeeding women,6.refuse to participate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of anti-tuberculosis drug-induced liver injury (AT-DILI) within 8 weeks follow up The incidence proportion will be calculated as number of participants who develop AT DILI divided by total number of enrolled participants multiplied by 100. | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to onset of AT-DILI within 8 weeks follow up days from start of anti tuberculosis treatment to first date meeting AT DILI criteria,Severity of liver injury within 8 weeks follow up worst clinical grade during 8 weeks classify per CTCAE version 5.0.,Change in liver enzymes within 8 weeks follow up absolute change in AST, ALT, ALP, total bilirubin from baseline at week 2, week 4, week 8,Change in Reactive oxygen species (ROS) within 8 weeks follow up absolute change in ROS level from baseline at week 2, week 4, week 8.,Resolution time of liver injury within 8 weeks follow up days from first qualifying AT DILI test to recovery.,Adverse drug reactions related to UDCA within 8 weeks follow up number and proportion of participants classify per CTCAE version 5.0. with at least one adverse event, and number with serious adverse event | — |
Countries
Thailand
Contacts
Public ContactChayanin Wanittansirichok
Department of Medicine, Faculty of Medicine, Khon Kaen University
Outcome results
None listed