Efficacy and Safety of AXA1665 in Cirrhotic Subjects With Prior Overt Hepatic Encephalopathy

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Hepatic Encephalopathy

In brief

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.

Key facts

Study ID

NCT04816916

Run by

Axcella Health, Inc

People needed

12

Starts

2021-06-29

Expected to finish

2022-06-30

Last updated by the study team

2022-07-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of California, San Francisco (UCSF) — San Francisco, California, United States
• OMEGA Research Consultants — DeBary, Florida, United States
• UF Hepatology Research at CTRB — Gainesville, Florida, United States
• Homestead Associates in Research — Miami, Florida, United States
• University of Miami — Miami, Florida, United States
• Indiana University School of Medicine — Indianapolis, Indiana, United States
• University of Iowa — Iowa City, Iowa, United States
• Mercy Medical Center — Baltimore, Maryland, United States
• New York University (NYU) School of Medicine — New York, New York, United States
• Weill Medical College of Cornell University — New York, New York, United States
• Cumberland Research Associates — Fayetteville, North Carolina, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• Medical University of South Carolina (MUSC) — Charleston, South Carolina, United States
• Optimed Research — Edinburg, Texas, United States
• Baylor Scott & White Research Institute — Fort Worth, Texas, United States
• Advanced Liver Therapies at St. Luke's Episcopal Hospital — Houston, Texas, United States
• Pinnacle Clinical Research — San Antonio, Texas, United States
• University of Virginia School of Medicine — Charlottesville, Virginia, United States
• Bon Secours Liver Institute — Newport News, Virginia, United States
• Virginia Commonwealth University — Richmond, Virginia, United States
• McGuire Research Institute, Inc., McGuire VA Medical Center — Richmond, Virginia, United States
• University of Calgary — Calgary, Alberta, Canada
• LMC Diabetes & Endocrinology Ltd. - London — London, Ontario, Canada
• The Ottawa Hospital — Ottawa, Canada
• Debreceni Egyetem Klinikai Kozpont — Debrecen, Hungary

Full record on ClinicalTrials.gov

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