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Analysis of Liver Injury Risk Factors in a Multiethnic Population Treated With Antituberculosis Drugs

NCT06539455 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 127

Last updated 2024-08-06

No results posted yet for this study

Summary

Tuberculosis (TB) is the world's second leading cause of death from a single infectious agent after COVID-19. In 2022, TB was estimated to have affected 10.6 million people, of whom 1.3 million died because of it, despite the WHO's implementation of the "End TB" program. Although the gold standard therapy is effective, it may lead to adverse events, among which hepatotoxicity is the most common. Due to its frequency, severity, and potential outcome, anti-TB drug-induced liver injury (DILI) is extremely concerning. Despite decades of use and the large number of patients exposed to anti-TB drugs worldwide, the pathogenesis underlying DILI remains poorly understood. Investigation of drug-related, host genetic, and environmental factors associated with hepatotoxicity susceptibility, as well as studies examining potential mechanisms causing DILI, may help clinicians develop strategies for reducing the incidence of hepatotoxicity. The aim of this study was to determine host- and drug-related risk factors and their association with hepatotoxicity in a multiethnic population in order to enable early identification of individuals with increased susceptibility to anti-TB DILI. An improved understanding of these factors may help to predict and prevent the occurrence of DILI and develop more effective treatments.

Conditions

  • Tuberculosis Infection

Interventions

DRUG

standard anti-TB treatment

standard anti-TB treatment in line with international guidelines (isoniazid , rifampin, ethambutol, and pyrazinamide)

Sponsors & Collaborators

  • Stefania Cheli

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-05
Primary Completion
2024-07-30
Completion
2024-09-30
FDA Drug
Yes

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06539455 on ClinicalTrials.gov