Status:
TERMINATED
Efficacy and Safety of AXA1665 in Cirrhotic Subjects With Prior Overt Hepatic Encephalopathy
Lead Sponsor:
Axcella Health, Inc
Conditions:
Hepatic Encephalopathy
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 AX...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 29 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2022
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04816916
Start Date
June 29 2021
End Date
June 30 2022
Last Update
July 27 2022
Active Locations (40)
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1
University of California, San Francisco (UCSF)
San Francisco, California, United States, 94143
2
OMEGA Research Consultants
DeBary, Florida, United States, 32713
3
UF Hepatology Research at CTRB
Gainesville, Florida, United States, 32610
4
Homestead Associates in Research
Miami, Florida, United States, 33032