Efficacy and Safety of AXA1665 in Cirrhotic Subjects With Prior Overt Hepatic Encephalopathy
Efficacy and Safety of AXA1665 in Cirrhotic Subjects With Prior Overt Hepatic Encephalopathy
This is a global study to compare the effects of AXA1665, an orally active mixture of amino
 acids, compared to placebo, on cognitive and physical function, as well as the safety and
 tolerability of AXA1665.
Inclusion Criteria:

 -  Willing to participate in the study and provide written informed consent.

 -  Male and female adults aged > 18 years.

 -  History of cirrhosis and at least 1 documented prior episode of overt hepatic
 encephalopathy within 24 weeks prior to Screening;

 -  A PHES ≤ -4 during Screening

 -  MELD-Na score of <20 at Screening

 -  Support of a primary caregiver who is able and willing to give written informed
 consent.

 Exclusion Criteria:

 -  Hospitalization or serious medical condiction

 -  History or presence of Child's Pugh class C, hepato-renal syndrome(s), refractory
 ascites or spontaneous bacterial peritonitis (SBP)

 -  History of a portosystemic or a transjugular intrahepatic portosystemic shunt (TIPS)
 placement;

 -  Expectation of a liver transplant during the study

 -  Screening Alcohol Use Disorders Identification Test (AUDIT) score ≥8