Experimental drug aims to halt liver failure in cirrhosis patients

NCT ID NCT07694297

Disease control Sponsor: Genfit Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 09, 2026 · Last updated Jul 10, 2026 · Updated 1 time

Summary

This study tests whether adding the drug NTZ to standard care can help people with liver cirrhosis who experience a sudden worsening (acute decompensation) or have developed acute-on-chronic liver failure. The trial enrolls adults with cirrhosis from any cause who have had a recent acute decline. Researchers are primarily checking if NTZ is safe and tolerable in this setting.

What this could mean

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

Active substance
NTZ (nitazoxanide)
What this could lead to
If successful, this could offer a new treatment option to stabilize patients with acute liver decompensation or early liver failure, potentially reducing progression and improving survival.
What could go wrong
This is an early-phase trial with only 16 participants, so results may not apply broadly. NTZ may cause side effects or fail to show benefit over standard care alone.
Why investors are watching

Genfit is running a small phase 2 trial testing its drug NTZ in patients with severe liver failure, a condition with few treatment options. For a micro-cap company, this readout could define whether its pipeline has a viable product, making the result highly consequential for its future.

If it works: A positive result could show NTZ helps stabilize or improve patients with acute-on-chronic liver failure, giving Genfit a path to a larger confirmatory trial and a potential new treatment for a serious unmet need.

If it fails: The trial enrolls only 16 patients, so results may be inconclusive or fail to show benefit. If the drug does not work or the trial hits delays, Genfit, as a very small company, could face a significant setback with limited other options.

AI-written from the trial record. Speculative, and not investment advice.

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.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 16 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

18 to 74 years

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: Participants are eligible to be included in the study only if all of the following criteria apply: * Participants with liver cirrhosis of any underlying etiology (liver cirrhosis diagnosed by standard clinical criteria, imaging findings, and/or histology) * Recent acute clinical deterioration within 10 days prior to Day 1 defined as the onset of ascites, HE, gastrointestinal bleeding, or any combination of them with or without infection with or without organ failure * Adult male or female participants, defined as having reached the legal age of majority according to local regulations, aged \<75 years on the day of signing informed consent form (ICF) * Participants or legal representative willing and able to provide written informed consent in accordance with local ethical and legal requirements * Participants able to swallow peroral medication Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply: 1. Known hypersensitivity to nitazoxanide or any known excipient of the IMP 2. Nitazoxanide use within 30 days prior to SCR 3. Uncontrolled acute bleeding at SCR or Day 1 4. Participants with poorly controlled seizure disorder 5. Severe circulatory failure requiring the use of high dose vasopressors (eg, dopamine \>15 μg/kg/min, or epinephrine \>0.1 μg/kg/min, or norepinephrine \>0.1 μg/kg/min); the use of terlipressin or low dose norepinephrine to treat hepatorenal syndrome is not an exclusion criterion 6. Uncontrolled severe infection with hemodynamic instability or shock 7. Need for renal replacement therapy (RRT) or any extracorporeal liver support device 8. Any significant disease considered to be potentially detrimental or would preclude the participant from participating in and completing the study as assessed by the PI 9. Individuals for whom the PI deems that study participation would be unsafe or not in the interest of the participant 10. Pregnancy or lactation 11. Participants of childbearing potential and non-sterile male participants who are not willing to use adequate contraception from SCR to 90 days after the final dose of IMP 12. Participation in another interventional clinical study within 30 days of SCR.

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Conditions

The condition(s) this trial relates to.

Acute-On-Chronic Liver Failure cirrhosis of liver liver failure

As listed by the trial registrant

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

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  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

Study contacts

  • Contact

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