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TERMINATEDPhase 2NCT04816916

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 AX...

Lead sponsor: Axcella Health, Inc•21 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Axcella Health, Inc

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

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 prior episode of overt hepatic encephalopathy (OHE) prior to Screening.
•A PHES of ≤ -4 during Screening.
•MELD score of ≤ 22 at Screening.
•Support of a primary caregiver who is able and willing to give written informed consent.

Exclusion Criteria

•Hospitalization or serious medical condition.
•Presence of Child's-Pugh score ≥12, hepato-renal syndrome(s), refractory ascites, or spontaneous bacterial peritonitis (SBP).
•History of a surgical portosystemic or a transjugular intrahepatic portosystemic shunt (TIPS) placement.
•Expectation of a liver transplant during the study.
•Use of marijuana or tetrahydrocannabinol (THC) within 1 week prior to Screening and during the study.

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: July 27, 2022Terms

Trial snapshot

StatusTERMINATED

PhasePHASE2

Enrollment12

Start dateJun 2021

Last updatedJul 27, 2022

Condition

Hepatic Encephalopathy

Locations shown

University of California, San Francisco (UCSF)

San Francisco, California

OMEGA Research Consultants

DeBary, Florida

UF Hepatology Research at CTRB

Gainesville, Florida

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 27, 2022Data synced to Clareo: May 25, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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