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TB drug liver risk under the microscope

NCT ID NCT07472348

Knowledge-focused Sponsor: ASST Fatebenefratelli Sacco Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study will track 220 adults being treated for tuberculosis (TB) or latent TB with the drug isoniazid. Researchers want to see how often the drug causes liver injury and what factors make it more likely. They will also look at how doctors manage this side effect in real-world practice. The goal is to make TB treatment safer by better understanding and preventing liver damage.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
isoniazid
What this could lead to
If successful, this study could help doctors identify who is at risk of liver injury from isoniazid and manage it better, making TB treatment safer.
What could go wrong
This is an observational study, not a trial testing a new treatment. It cannot prove cause and effect, and results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 220 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Study participants will be adults being treated for TB or LTBI at the Department of Infectious Diseases at Luigi Sacco Hospital in Milan, a regional referral center for TB management. The population includes individuals treated both inpatient and outpatient settings, whose clinical, laboratory, imaging, microbiological, and treatment data were routinely collected as part of standard care. The study comprises two sources: a retrospective cohort of adults treated with isoniazid between 2020 and 2025 and a prospective cohort enrolled between 2026 and 2028. Together, these groups represent the real-world patient population managed at this center for the treatment of TB and LTBI.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * Patients who did not receive isoniazid during their treatment course. * Pre-existing liver dysfunction, including biliary origin, before anti-TB therapy. * Pregnancy or lactation. * Concomitant use of non-TB hepatotoxic drugs. * Abnormal hepatic function on baseline laboratory testing. * Known INH resistance at treatment initiation. * Refusal to provide informed consent.

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Conditions

The condition(s) this trial relates to.

drug-induced liver injury Drug-Related Side Effects and Adverse Reactions latent tuberculosis infection tuberculosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Tuberculosis infection Tuberculosis infection, latent

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • ASST Fatebenefratelli Sacco Hospital

    Milan, Italy, 20157, Italy

More trials for these conditions

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