Efficacy and Safety of AXA1665 in Cirrhotic Subjects With Prior Overt Hepatic Encephalopathy (NCT04816916) | Clinical Trial Compass
TerminatedPhase 2
Efficacy and Safety of AXA1665 in Cirrhotic Subjects With Prior Overt Hepatic Encephalopathy
Stopped: Sponsor is stopping the study to focus company resources on other development programs.
United States, Canada, Hungary12 participantsStarted 2021-06-29
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in neurocognitive function by Psychometric Hepatic Encephalopathy Score (PHES)