NCT07472348Not yet recruiting
Isoniazid-Related Hepatotoxicity in Clinical Practice: Incidence and Predictors
Observational Study on Isoniazid-Induced Hepatotoxicity: Incidence, Risk Factors and Therapeutic Strategies
Source: ClinicalTrials.gov · Last updated 16 Mar 2026
Brief summary (registry, in English)
The objective of this observational study is to determine how frequently isoniazid (INH) causes liver injury (hepatotoxicity) in adults treated for tuberculosis (TB) or latent tuberculosis infection (LTBI) and to understand which factors increase this risk. The study also aims to describe how hepatotoxicity is managed in real-world clinical practice and whether treatments such as corticosteroids can improve liver function tests. The main questions this study aims to answer are: * How frequently does INH-induced hepatotoxicity occur in adults treated for TB or LTBI? * What demographic, clinical, microbiological, or lifestyle factors increase the risk of developing hepatotoxicity? * How do different management strategies, including treatment modification or the use of corticosteroids, affect liver recovery and completion of TB/LTBI therapy? This study does not involve experimental treatments. Researchers will analyze information already collected during routine clinical care, both retrospectively (from 2020 to 2025) and prospectively (2026-2028). There is no comparison group, but participants may have different clinical profiles or treatments, which will be compared to understand risk factors and outcomes. Participants will: * Receive standard treatment for tuberculosis or LTBI, including isoniazid, as prescribed by their treating physicians. * Undergo routine assessments, such as blood tests, microbiology, imaging, and clinic visits, as part of their regular care. * Their clinical data will be recorded in the study database to analyze liver function trends, treatment changes, and outcomes. The study will contribute to improving understanding of INH-induced hepatotoxicity and supporting safer and more effective treatment strategies for tuberculosis and LTBI.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 220 (estimated)
- First submitted
- 5 Mar 2026
- Start date
- 30 May 2026
- Primary completion date
- 31 Jul 2026
- Lead sponsor
- ASST Fatebenefratelli Sacco
- Diseases
- Tuberculosis
- NCT number
- NCT07472348
What you commit to
- Study type: Observational
- Planned participants: 220
- From 30 May 2026 to the primary completion date, 31 Jul 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Pre-existing liver dysfunction, including biliary origin, before anti-TB therapy.
- Concomitant use of non-TB hepatotoxic drugs.
Lab values
- Abnormal hepatic function on baseline laboratory testing.
Other
- Patients who did not receive isoniazid during their treatment course.
- Pregnancy or lactation.
- Known INH resistance at treatment initiation.
- Refusal to provide informed consent.
Who the study is looking for
- Adults aged ≥18 years.
- Patients diagnosed with TB or LTBI who received INH as part of their treatment regimen (either first-line or second-line therapy), regardless of combination with other anti-TB drugs.
- Normal baseline liver function tests (ALT, AST and bilirubin within reference range) and absence of clinical symptoms of liver dysfunction prior to initiation of anti-TB therapy.
- Signed informed consent.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| ASST Fatebenefratelli Sacco Hospital Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.