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

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:

• 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
• Individuals for whom the PI deems that study participation would be unsafe or not in the interest of the participant
• Pregnancy or lactation
• 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
• Participation in another interventional clinical study within 30 days of SCR.