Protocol Summary

Protocol No.: OCR40623

Protocol Title.: Efficacy and Safety of AXA1665 in Cirrhotic Subjects With Prior Overt Hepatic Encephalopathy

Principal Investigator: Morelli, Giuseppe

Objective: 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.

Phase: Phase II

Age Group: Adult

Age: 18 Years - N/A

Gender: All

Scope: National

Treatment:

Experimental: AXA1665 53.8 g per day
AXA1665 administered orally TID

Placebo Comparator: Matching placebo
Placebo administered orally TID

Detailed Eligibility:

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 condition - 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

Applicable Conditions:

  • Cirrhosis
  • Participation Institution:

  • No UF Health MRN : Briana Foerman
  • UF Gainesville : Briana Foerman
  • UF Jacksonville : Briana Foerman
  • UF Leesburg : Briana Foerman
  • UF Villages : Briana Foerman
  • Contact:
    Briana Foerman
    Phone: +1 352-294-5152
    Email: bfoerman@ufl.edu

    More Information: View study listing on ClinicialTrials.gov http://www.clinicaltrials.gov/ct2/show/NCT04816916