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

Primary Purpose

Hepatic Encephalopathy

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
AXA1665
Placebo
Sponsored by
Axcella Health, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatic Encephalopathy focused on measuring liver cirrhosis, end stage liver disease, sarcopenia, amino acids

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of California, San Francisco (UCSF)
  • OMEGA Research Consultants
  • UF Hepatology Research at CTRB
  • Homestead Associates in Research
  • University of Miami
  • Indiana University School of Medicine
  • University of Iowa
  • Mercy Medical Center
  • New York University (NYU) School of Medicine
  • Weill Medical College of Cornell University
  • Cumberland Research Associates
  • University of Pittsburgh Medical Center
  • Medical University of South Carolina (MUSC)
  • Optimed Research
  • Baylor Scott & White Research Institute
  • Advanced Liver Therapies at St. Luke's Episcopal Hospital
  • Pinnacle Clinical Research
  • University of Virginia School of Medicine
  • Bon Secours Liver Institute
  • Virginia Commonwealth University
  • McGuire Research Institute, Inc., McGuire VA Medical Center
  • University of Calgary
  • LMC Diabetes & Endocrinology Ltd. - London
  • The Ottawa Hospital
  • Debreceni Egyetem Klinikai Kozpont
  • Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
  • Azienda Ospedaliera Universitaria Federico II
  • Azienda sanitaria universitaria Friuli Centrale (ASU FC)
  • KO - MED Centra Kliniczne Lublin II
  • ID Clinic
  • SONOMED Sp. z o.o.
  • Prywatna Specjalistyczna Praktyka Lekarska Jan Gietka
  • Centrum Badan Klinicznych Piotr Napora Lekarze Sp. p.
  • Corporacio Sanitaria Parc Tauli - Hospital de Sabadell
  • Hospital Universitario Vall d'Hebron
  • Hospital Universitario Puerta de Hierro
  • Hospital Universitario Marques de Valdecilla
  • Hospital Clinico Universitario de Santiago
  • Hospital Universitario Virgen del Rocio
  • The Royal Infirmary of Edinburgh

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

AXA1665 53.8 g per day

Matching placebo

Arm Description

AXA1665 administered orally TID

Placebo administered orally TID

Outcomes

Primary Outcome Measures

Change in neurocognitive function by Psychometric Hepatic Encephalopathy Score (PHES)

Secondary Outcome Measures

Time to and frequency of recurrent overt hepatic encephalopathy
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)
Incidence of study product emergent adverse events (AEs) and serious adverse events (SAEs)

Full Information

First Posted
March 19, 2021
Last Updated
July 26, 2022
Sponsor
Axcella Health, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT04816916
Brief Title
Efficacy and Safety of AXA1665 in Cirrhotic Subjects With Prior Overt Hepatic Encephalopathy
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Terminated
Why Stopped
Sponsor is stopping the study to focus company resources on other development programs.
Study Start Date
June 29, 2021 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
June 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Axcella Health, Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatic Encephalopathy
Keywords
liver cirrhosis, end stage liver disease, sarcopenia, amino acids

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AXA1665 53.8 g per day
Arm Type
Experimental
Arm Description
AXA1665 administered orally TID
Arm Title
Matching placebo
Arm Type
Placebo Comparator
Arm Description
Placebo administered orally TID
Intervention Type
Drug
Intervention Name(s)
AXA1665
Intervention Description
AXA1665 administered TID with food
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo administered TID with food
Primary Outcome Measure Information:
Title
Change in neurocognitive function by Psychometric Hepatic Encephalopathy Score (PHES)
Time Frame
Baseline to week 24
Secondary Outcome Measure Information:
Title
Time to and frequency of recurrent overt hepatic encephalopathy
Time Frame
Baseline to week 24
Title
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)
Time Frame
Baseline to week 24
Title
Incidence of study product emergent adverse events (AEs) and serious adverse events (SAEs)
Time Frame
Baseline to week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andres Duarte-Rojo, M.D.
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco (UCSF)
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
OMEGA Research Consultants
City
DeBary
State/Province
Florida
ZIP/Postal Code
32713
Country
United States
Facility Name
UF Hepatology Research at CTRB
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Homestead Associates in Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33032
Country
United States
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Indiana University School of Medicine
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Mercy Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21202
Country
United States
Facility Name
New York University (NYU) School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Weill Medical College of Cornell University
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Cumberland Research Associates
City
Fayetteville
State/Province
North Carolina
ZIP/Postal Code
28304
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Medical University of South Carolina (MUSC)
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Optimed Research
City
Edinburg
State/Province
Texas
ZIP/Postal Code
78359
Country
United States
Facility Name
Baylor Scott & White Research Institute
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Advanced Liver Therapies at St. Luke's Episcopal Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Pinnacle Clinical Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
University of Virginia School of Medicine
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Facility Name
Bon Secours Liver Institute
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23602
Country
United States
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23114
Country
United States
Facility Name
McGuire Research Institute, Inc., McGuire VA Medical Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
Facility Name
University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4Z6
Country
Canada
Facility Name
LMC Diabetes & Endocrinology Ltd. - London
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 2C2
Country
Canada
Facility Name
The Ottawa Hospital
City
Ottawa
Country
Canada
Facility Name
Debreceni Egyetem Klinikai Kozpont
City
Debrecen
Country
Hungary
Facility Name
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
City
Székesfehérvár
Country
Hungary
Facility Name
Azienda Ospedaliera Universitaria Federico II
City
Naples
ZIP/Postal Code
80131
Country
Italy
Facility Name
Azienda sanitaria universitaria Friuli Centrale (ASU FC)
City
Udine
ZIP/Postal Code
33100
Country
Italy
Facility Name
KO - MED Centra Kliniczne Lublin II
City
Lublin
Country
Poland
Facility Name
ID Clinic
City
Mysłowice
Country
Poland
Facility Name
SONOMED Sp. z o.o.
City
Szczecin
Country
Poland
Facility Name
Prywatna Specjalistyczna Praktyka Lekarska Jan Gietka
City
Warszawa
Country
Poland
Facility Name
Centrum Badan Klinicznych Piotr Napora Lekarze Sp. p.
City
Wrocław
Country
Poland
Facility Name
Corporacio Sanitaria Parc Tauli - Hospital de Sabadell
City
Barcelona
Country
Spain
Facility Name
Hospital Universitario Vall d'Hebron
City
Barcelona
Country
Spain
Facility Name
Hospital Universitario Puerta de Hierro
City
Majadahonda
ZIP/Postal Code
28222
Country
Spain
Facility Name
Hospital Universitario Marques de Valdecilla
City
Santander
Country
Spain
Facility Name
Hospital Clinico Universitario de Santiago
City
Santiago De Compostela
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocio
City
Sevilla
Country
Spain
Facility Name
The Royal Infirmary of Edinburgh
City
Edinburgh
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
https://emmpowertrial.com/
Description
EMMPOWER Phase 2 Clinical Trial Homepage

Learn more about this trial

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

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