Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion

Description

Summary

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.

Official Title

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of AXA1665 in Subjects With Liver Cirrhosis and Prior Overt Hepatic Encephalopathy (EMMPOWER)

Keywords

Hepatic Encephalopathy liver cirrhosis end stage liver disease sarcopenia amino acids Brain Diseases AXA1665 AXA1665 53.8 g per day

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

  • 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

Locations

  • University of California, San Francisco (UCSF) accepting new patients
    San Francisco California 94143 United States
  • University of Calgary accepting new patients
    Calgary Alberta T2N 4Z6 Canada

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Axcella Health, Inc
ID
NCT04816916
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 150 study participants
Last Updated