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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04816916
Recruitment Status : Recruiting
First Posted : March 25, 2021
Last Update Posted : January 13, 2022
Sponsor:
Information provided by (Responsible Party):
Axcella Health, Inc

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hepatic Encephalopathy Drug: AXA1665 Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)
Actual Study Start Date : June 29, 2021
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : March 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Change in neurocognitive function by Psychometric Hepatic Encephalopathy Score (PHES) [ Time Frame: Baseline to week 24 ]

Secondary Outcome Measures :
  1. Time to and frequency of recurrent overt hepatic encephalopathy [ Time Frame: Baseline to week 24 ]
  2. 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 ]
  3. Incidence of study product emergent adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: Baseline to week 24 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 documented prior episode of overt hepatic encephalopathy within 24 weeks prior to Screening;
  • A PHES ≤ -4 during Screening
  • MELD-Na score of <20 at Screening
  • Support of a primary caregiver who is able and willing to give written informed consent.

Exclusion Criteria:

  • Hospitalization or serious medical condition
  • History or presence of Child's Pugh class C, hepato-renal syndrome(s), refractory ascites or spontaneous bacterial peritonitis (SBP)
  • History of a portosystemic or a transjugular intrahepatic portosystemic shunt (TIPS) placement;
  • Expectation of a liver transplant during the study
  • Screening Alcohol Use Disorders Identification Test (AUDIT) score ≥8
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04816916


Contacts
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Contact: Margaret Koziel, M.D. 1-857-320-2200 clinicaltrials@axcellaheath.com

Locations
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Sponsors and Collaborators
Axcella Health, Inc
Investigators
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Principal Investigator: Andres Duarte-Rojo, M.D. University of Pittsburgh
More Information
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Responsible Party: Axcella Health, Inc
ClinicalTrials.gov Identifier: NCT04816916    
Other Study ID Numbers: AXA1665-101
First Posted: March 25, 2021    Key Record Dates
Last Update Posted: January 13, 2022
Last Verified: November 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Axcella Health, Inc:
liver cirrhosis
end stage liver disease
sarcopenia
amino acids
Additional relevant MeSH terms:
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Hepatic Encephalopathy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Liver Diseases
 Digestive System Diseases
Liver Failure
Hepatic Insufficiency
Brain Diseases, Metabolic
Metabolic Diseases