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
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
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