Efficacy and Safety of AXA1665 in Cirrhotic Subjects With Prior Overt Hepatic Encephalopathy (EMMPOWER)
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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. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT04816916 |
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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
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Sponsor:
Axcella Health, Inc
Information provided by (Responsible Party):
Axcella Health, Inc
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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 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 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
North American Indian childhood cirrhosis
| Arm | Intervention/treatment |
|---|---|
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Experimental: AXA1665 53.8 g per day
AXA1665 administered orally TID
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Drug: AXA1665
AXA1665 administered TID with food |
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Placebo Comparator: Matching placebo
Placebo administered orally TID
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Drug: Placebo
Matching placebo administered TID with food |
Primary Outcome Measures :
- Change in neurocognitive function by Psychometric Hepatic Encephalopathy Score (PHES) [ Time Frame: Baseline to week 24 ]
Secondary Outcome Measures :
- Time to and frequency of recurrent overt hepatic encephalopathy [ Time Frame: 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 ]
- Incidence of study product emergent adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: Baseline to week 24 ]
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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 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
Locations
Show 40 study locations
Sponsors and Collaborators
Axcella Health, Inc
Investigators
| Principal Investigator: | Andres Duarte-Rojo, M.D. | University of Pittsburgh |
Additional Information:
| 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 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Axcella Health, Inc:
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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 |