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

July 26, 2022 updated by: Axcella Health, Inc

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)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
12

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Ottawa, Canada
        • The Ottawa Hospital
    • Alberta
      • Calgary, Alberta, Canada, T2N 4Z6
        • University Of Calgary
    • Ontario
      • London, Ontario, Canada, N6A 2C2
        • LMC Diabetes & Endocrinology Ltd. - London
  • Hungary
      • Debrecen, Hungary
        • Debreceni Egyetem Klinikai Kozpont
      • Székesfehérvár, Hungary
        • Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
  • Italy
      • Naples, Italy, 80131
        • Azienda Ospedaliera Universitaria Federico II
      • Udine, Italy, 33100
        • Azienda Sanitaria Universitaria Friuli Centrale (ASU FC)
  • Poland
      • Lublin, Poland
        • KO - MED Centra Kliniczne Lublin II
      • Mysłowice, Poland
        • ID Clinic
      • Szczecin, Poland
        • Sonomed Sp. z o.o.
      • Warszawa, Poland
        • Prywatna Specjalistyczna Praktyka Lekarska Jan Gietka
      • Wrocław, Poland
        • Centrum Badań Klinicznych Piotr Napora Lekarze Sp. p.
  • Spain
      • Barcelona, Spain
        • Hospital Universitario Vall d'Hebron
      • Barcelona, Spain
        • Corporacio Sanitaria Parc Tauli - Hospital de Sabadell
      • Majadahonda, Spain, 28222
        • Hospital Universitario Puerta De Hierro
      • Santander, Spain
        • Hospital Universitario Marqués de Valdecilla
      • Santiago De Compostela, Spain
        • Hospital Clínico Universitario de Santiago
      • Sevilla, Spain
        • Hospital Universitario Virgen del Rocío
  • United Kingdom
      • Edinburgh, United Kingdom
        • The Royal Infirmary of Edinburgh
  • United States
    • California
      • San Francisco, California, United States, 94143
        • University of California, San Francisco (UCSF)
    • Florida
      • DeBary, Florida, United States, 32713
        • Omega Research Consultants
      • Gainesville, Florida, United States, 32610
        • UF Hepatology Research at CTRB
      • Miami, Florida, United States, 33136
        • University of Miami
      • Miami, Florida, United States, 33032
        • Homestead Associates in Research
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University School of Medicine
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa
    • Maryland
      • Baltimore, Maryland, United States, 21202
        • Mercy Medical Center
    • New York
      • New York, New York, United States, 10021
        • Weill Medical College of Cornell University
      • New York, New York, United States, 10016
        • New York University (NYU) School of Medicine
    • North Carolina
      • Fayetteville, North Carolina, United States, 28304
        • Cumberland Research Associates
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Medical Center
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina (MUSC)
    • Texas
      • Edinburg, Texas, United States, 78359
        • Optimed Research
      • Fort Worth, Texas, United States, 75246
        • Baylor Scott & White Research Institute
      • Houston, Texas, United States, 77030
        • Advanced Liver Therapies at St. Luke's Episcopal Hospital
      • San Antonio, Texas, United States, 78229
        • Pinnacle Clinical Research
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • University of Virginia School of Medicine
      • Newport News, Virginia, United States, 23602
        • Bon Secours Liver Institute
      • Richmond, Virginia, United States, 23114
        • Virginia Commonwealth University
      • Richmond, Virginia, United States, 23249
        • McGuire Research Institute, Inc., McGuire VA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: AXA1665 53.8 g per day
AXA1665 administered orally TID
Drug: AXA1665
AXA1665 administered TID with food
Placebo Comparator: Matching placebo
Placebo administered orally TID
Drug: Placebo
Matching placebo administered TID with food

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change in neurocognitive function by Psychometric Hepatic Encephalopathy Score (PHES)
Time Frame: Baseline to week 24
Baseline to week 24

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Time to and frequency of recurrent overt hepatic encephalopathy
Time Frame: Baseline to week 24
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)
Time Frame: Baseline to week 24
Baseline to week 24
Incidence of study product emergent adverse events (AEs) and serious adverse events (SAEs)
Time Frame: Baseline to week 24
Baseline to week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Axcella Health, Inc

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Andres Duarte-Rojo, M.D., University of Pittsburgh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 29, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 19, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 27, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 26, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AXA1665-101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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