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

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ClinicalTrials.gov Identifier: NCT04816916
Recruitment Status : Terminated (Sponsor is stopping the study to focus company resources on other development programs.)
First Posted : March 25, 2021
Last Update Posted : July 27, 2022
Information provided by (Responsible Party):
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.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 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
Actual Primary Completion Date : June 30, 2022
Actual Study Completion Date : June 30, 2022

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

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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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

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Sponsors and Collaborators
Axcella Health, Inc
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Principal Investigator: Andres Duarte-Rojo, M.D. University of Pittsburgh
Additional 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: July 27, 2022
Last Verified: July 2022

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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
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