Study of the Safety and Tolerability of AXA1665 in Subjects With Mild and Moderate Hepatic Insufficiency
NCT ID: NCT04147936
Last Updated: 2020-09-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2019-03-30
2020-06-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
SINGLE
Study Groups
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AXA1665 29.4g
Dietary Supplement: AXA1665 Amino acids, food study
AXA1665
Dietary supplement: AXA1665
AXA1665 53.9 g
Dietary Supplement: AXA1665 Amino acids, food study
AXA1665
Dietary supplement: AXA1665
Placebo 29.4 g
Dietary Supplement: Placebo
Placebo
Placebo
Interventions
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AXA1665
Dietary supplement: AXA1665
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
* Male and female adults aged \> 18 years
* Child-Pugh score ≤9 (i.e. Child-Pugh class A or B)
* Liver Frailty Index (LFI) of ≥3.6
* Willing and able to engage in 30 minutes of walking/physical activity at least 3 days per week
Exclusion Criteria
* Prior history or presence of a transjugular intrahepatic portal systemic shunt (TIPS)
* Current or history of significant alcohol consumption
* Other poorly controlled medical condition \[e.g., renal disease with an estimated glomerular filtration rate (GFR) \<60 mL/min/1.73m2)
* Known sensitivity and/or history of clinically significant food intolerance/allergies to proteins (including whey, soy, casein, amino acids, etc.)
* Any extreme or unbalanced diet such as Ketogenic, Atkins, Paleo, Vegan, etc.
* Unable or unwilling to adhere to contraception requirements
* Any contraindications to a MRI scan
* Any other condition that, in the opinion of the Investigator, renders the subject at risk for compliance, compromises the well-being of the subject, or hinders study completion
18 Years
ALL
No
Sponsors
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Axcella Health, Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Arun J Sanyal, MD
Role: PRINCIPAL_INVESTIGATOR
Virginia Commonwealth University
Locations
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Catalina Research Institute, LLC
Montclair, California, United States
Orange County Research Center
Tustin, California, United States
Panax Clinical Research
Miami Lakes, Florida, United States
OMEGA Research Maitland, LCC
Orlando, Florida, United States
Avita Clinical Research
Tampa, Florida, United States
Atlanta Center for Medical Research
Atlanta, Georgia, United States
Indiana University Health
Indianapolis, Indiana, United States
Delta Research Partners
Bastrop, Louisiana, United States
UPMC Center for Liver Disease
Pittsburgh, Pennsylvania, United States
Texas Liver Institute
San Antonio, Texas, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Countries
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Other Identifiers
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AXA1665-002
Identifier Type: -
Identifier Source: org_study_id
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