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

Hepatic Encephalopathy Clinical Trial

— EMMPOWER  

Official title:

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of AXA1665 in Subjects With Liver Cirrhosis and Prior Overt Hepatic Encephalopathy (EMMPOWER)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04816916
• Other study ID #: AXA1665-101
• Status: Terminated
• Phase: Phase 2
• Start date: June 29, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: July 2022
• Source: Axcella Health, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Brain Diseases
• Hepatic Encephalopathy

Intervention

Drug:
• AXA1665
AXA1665 administered TID with food
• Placebo
Matching placebo administered TID with food

Locations

Country	Name	City	State
Canada	University of Calgary	Calgary	Alberta
Canada	LMC Diabetes & Endocrinology Ltd. - London	London	Ontario
Canada	The Ottawa Hospital	Ottawa
Hungary	Debreceni Egyetem Klinikai Kozpont	Debrecen
Hungary	Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz	Székesfehérvár
Italy	Azienda Ospedaliera Universitaria Federico II	Naples
Italy	Azienda sanitaria universitaria Friuli Centrale (ASU FC)	Udine
Poland	KO - MED Centra Kliniczne Lublin II	Lublin
Poland	ID Clinic	Myslowice
Poland	SONOMED Sp. z o.o.	Szczecin
Poland	Prywatna Specjalistyczna Praktyka Lekarska Jan Gietka	Warszawa
Poland	Centrum Badan Klinicznych Piotr Napora Lekarze Sp. p.	Wroclaw
Spain	Corporacio Sanitaria Parc Tauli - Hospital de Sabadell	Barcelona
Spain	Hospital Universitario Vall d'Hebron	Barcelona
Spain	Hospital Universitario Puerta de Hierro	Majadahonda
Spain	Hospital Universitario Marques de Valdecilla	Santander
Spain	Hospital Clinico Universitario de Santiago	Santiago De Compostela
Spain	Hospital Universitario Virgen del Rocio	Sevilla
United Kingdom	The Royal Infirmary of Edinburgh	Edinburgh
United States	Mercy Medical Center	Baltimore	Maryland
United States	Medical University of South Carolina (MUSC)	Charleston	South Carolina
United States	University of Virginia School of Medicine	Charlottesville	Virginia
United States	OMEGA Research Consultants	DeBary	Florida
United States	Optimed Research	Edinburg	Texas
United States	Cumberland Research Associates	Fayetteville	North Carolina
United States	Baylor Scott & White Research Institute	Fort Worth	Texas
United States	UF Hepatology Research at CTRB	Gainesville	Florida
United States	Advanced Liver Therapies at St. Luke's Episcopal Hospital	Houston	Texas
United States	Indiana University School of Medicine	Indianapolis	Indiana
United States	University of Iowa	Iowa City	Iowa
United States	Homestead Associates in Research	Miami	Florida
United States	University of Miami	Miami	Florida
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	Bon Secours Liver Institute	Newport News	Virginia
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	McGuire Research Institute, Inc., McGuire VA Medical Center	Richmond	Virginia
United States	Virginia Commonwealth University	Richmond	Virginia
United States	Pinnacle Clinical Research	San Antonio	Texas
United States	University of California, San Francisco (UCSF)	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Axcella Health, Inc

Countries where clinical trial is conducted

United States,  Canada,  Hungary,  Italy,  Poland,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in neurocognitive function by Psychometric Hepatic Encephalopathy Score (PHES)		Baseline to week 24
Secondary	Time to and frequency of recurrent overt hepatic encephalopathy		Baseline to week 24
Secondary	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
Secondary	Incidence of study product emergent adverse events (AEs) and serious adverse events (SAEs)		Baseline to week 24

External Links

•   EMMPOWER Phase 2 Clinical Trial Homepage