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

Phase 2

Terminated

• Conditions: Hepatic Encephalopathy
• Interventions: Drug: Placebo; Drug: AXA1665

• Registration Number: NCT04816916
• Lead Sponsor: Axcella Health, Inc

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 AXA1665.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-19
• Study First Submitted QC: 2021-03-24
• Study First Posted: 2021-03-25
• Study Start: 2021-06-29
• Primary Completion: 2022-06-30
• Study Completion: 2022-06-30
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-26
• Last Update Posted: 2022-07-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Matching placebo	Placebo	Placebo administered orally TID
AXA1665 53.8 g per day	AXA1665	AXA1665 administered orally TID

Primary Outcome Measures

Name	Time	Method
Change in neurocognitive function by Psychometric Hepatic Encephalopathy Score (PHES)	Baseline to week 24

Secondary Outcome Measures

Name	Time	Method
Time to and frequency of recurrent overt hepatic encephalopathy	Baseline to week 24
Impact on physical function assessed by Liver Frailty Index (a composite measure of hand grip strength, balance and ability to stand up from a chair)	Baseline to week 24
Incidence of study product emergent adverse events (AEs) and serious adverse events (SAEs)	Baseline to week 24

Trial Locations

Locations (40)

University of Iowa; 🇺🇸 Iowa City, Iowa, United States

University of Virginia School of Medicine; 🇺🇸 Charlottesville, Virginia, United States

McGuire Research Institute, Inc., McGuire VA Medical Center; 🇺🇸 Richmond, Virginia, United States

OMEGA Research Consultants; 🇺🇸 DeBary, Florida, United States

University of Pittsburgh Medical Center; 🇺🇸 Pittsburgh, Pennsylvania, United States

Baylor Scott & White Research Institute; 🇺🇸 Fort Worth, Texas, United States

New York University (NYU) School of Medicine; 🇺🇸 New York, New York, United States

Bon Secours Liver Institute; 🇺🇸 Newport News, Virginia, United States

University of California, San Francisco (UCSF); 🇺🇸 San Francisco, California, United States

UF Hepatology Research at CTRB; 🇺🇸 Gainesville, Florida, United States

Medical University of South Carolina (MUSC); 🇺🇸 Charleston, South Carolina, United States

Weill Medical College of Cornell University; 🇺🇸 New York, New York, United States

Advanced Liver Therapies at St. Luke's Episcopal Hospital; 🇺🇸 Houston, Texas, United States

LMC Diabetes & Endocrinology Ltd. - London; 🇨🇦 London, Ontario, Canada

Azienda Ospedaliera Universitaria Federico II; 🇮🇹 Naples, Italy

Homestead Associates in Research; 🇺🇸 Miami, Florida, United States

University of Miami; 🇺🇸 Miami, Florida, United States

Pinnacle Clinical Research; 🇺🇸 San Antonio, Texas, United States

KO - MED Centra Kliniczne Lublin II; 🇵🇱 Lublin, Poland

SONOMED Sp. z o.o.; 🇵🇱 Szczecin, Poland

The Ottawa Hospital; 🇨🇦 Ottawa, Canada

Optimed Research; 🇺🇸 Edinburg, Texas, United States

Hospital Universitario Puerta de Hierro; 🇪🇸 Majadahonda, Spain

The Royal Infirmary of Edinburgh; 🇬🇧 Edinburgh, United Kingdom

Corporacio Sanitaria Parc Tauli - Hospital de Sabadell; 🇪🇸 Barcelona, Spain

Centrum Badan Klinicznych Piotr Napora Lekarze Sp. p.; 🇵🇱 Wrocław, Poland

Azienda sanitaria universitaria Friuli Centrale (ASU FC); 🇮🇹 Udine, Italy

Hospital Universitario Marques de Valdecilla; 🇪🇸 Santander, Spain

Prywatna Specjalistyczna Praktyka Lekarska Jan Gietka; 🇵🇱 Warszawa, Poland

Mercy Medical Center; 🇺🇸 Baltimore, Maryland, United States

University of Calgary; 🇨🇦 Calgary, Alberta, Canada

Hospital Universitario Vall d'Hebron; 🇪🇸 Barcelona, Spain

Hospital Universitario Virgen del Rocio; 🇪🇸 Sevilla, Spain

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States

Cumberland Research Associates; 🇺🇸 Fayetteville, North Carolina, United States

Debreceni Egyetem Klinikai Kozpont; 🇭🇺 Debrecen, Hungary

Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz; 🇭🇺 Székesfehérvár, Hungary

Hospital Clinico Universitario de Santiago; 🇪🇸 Santiago De Compostela, Spain

ID Clinic; 🇵🇱 Mysłowice, Poland

Indiana University School of Medicine; 🇺🇸 Indianapolis, Indiana, United States