Not Yet RecruitingPhase 2

Phase 2 Study of 500 mg BID NTZ on Top of Standard of Care in Patients With Acute Decompensation of Liver Cirrhosis at High Risk of Progression to Acute-on-Chronic Liver Failure or Established Acute-on-Chronic Liver Failure

16 participantsStarted 2026-10

Plain-language summary

Phase 2 Study of 500 mg BID NTZ on Top of Standard of Care in Patients with Acute Decompensation of Liver Cirrhosis at High Risk of Progression to Acute-on-Chronic Liver Failure or Established Acute-on-Chronic Liver Failure

Who can participate

Age range

18 Years – 74 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

. Known hypersensitivity to nitazoxanide or any known excipient of the IMP
. Nitazoxanide use within 30 days prior to SCR
. Uncontrolled acute bleeding at SCR or Day 1
. Participants with poorly controlled seizure disorder
. 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
. Uncontrolled severe infection with hemodynamic instability or shock
. Need for renal replacement therapy (RRT) or any extracorporeal liver support device
. 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

To evaluate the safety of 500 mg BID NTZ administered perorally

Timeframe: over 7 days on top of SOC follow-up period up to Day 28.

Trial details

NCT IDNCT07694297

SponsorGenfit

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-08

Contact for this trial

Pejvack Motlagh, MD, MSc

+333 20 16 40 00 contact@genfit.com

View on ClinicalTrials.gov More Acute Decompensation of Liver Cirrhosis trials