Study of the Safety and Tolerability of AXA1665 in Subjects With Mild and Moderate Hepatic Insufficiency
A 12-Week, Single-Blind, Placebo-Controlled, Randomized Study to Evaluate the Safety, Tolerability, and Physiological Regulation of an Amino Acid Food Product, AXA1665, in Subjects With Mild and Moderate Hepatic Insufficiency
1 other identifier
interventional
60
1 country
11
Brief Summary
This is a randomized, single blind study to determine whether AXA1665, a composition of naturally occuring amino acids, is well tolerated in subjects with mild and moderate hepatic insufficiency. Study will also examine how the food product may influence the biology in muscle which will be assessed using magnetic resonance imaging (MRI) and other functional assessments such as strength, balance and cognition as part of a comprehensive physical/neurological exam. Changes in blood biomarkers of inflammation will also be assessed.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2019
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 30, 2019
CompletedFirst Submitted
Initial submission to the registry
October 21, 2019
CompletedFirst Posted
Study publicly available on registry
November 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 20, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 24, 2020
CompletedSeptember 18, 2020
September 1, 2020
1.1 years
October 21, 2019
September 17, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of study product emergent adverse events (AEs) and serious adverse events (SAEs)
Baseline to Week 12
Secondary Outcomes (9)
Change in muscle mass by MRI
Baseline to Week 12
Change in Fischer's ratio [measured by ratio of branched-chain amino acids (leucine, valine, isoleucine) to aromatic amino acids (phenylalanine, tyrosine)]
Baseline to Week 12
Change in plasma ammonia
Baseline to Week 12
Change in blood urea nitrogen concentration
Baseline to Week 12
Change in creatinine concentration
Baseline to Week 12
- +4 more secondary outcomes
Study Arms (3)
AXA1665 29.4g
ACTIVE COMPARATORDietary Supplement: AXA1665 Amino acids, food study
AXA1665 53.9 g
ACTIVE COMPARATORDietary Supplement: AXA1665 Amino acids, food study
Placebo 29.4 g
PLACEBO COMPARATORDietary Supplement: Placebo
Interventions
Eligibility Criteria
You may qualify if:
- Willing to participate in the study and provide written informed consent
- 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
You may not qualify if:
- Hospitalization for any complication of cirrhosis or taking new medications intended to treat hepatic encephalopathy within 2 months prior to Screening or any hospitalization for any cause/reason within 30 days prior to Screening
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Catalina Research Institute, LLC
Montclair, California, 91762, United States
Orange County Research Center
Tustin, California, 92780, United States
Panax Clinical Research
Miami Lakes, Florida, 33014, United States
OMEGA Research Maitland, LCC
Orlando, Florida, 32810, United States
Avita Clinical Research
Tampa, Florida, 33613, United States
Atlanta Center for Medical Research
Atlanta, Georgia, 30331, United States
Indiana University Health
Indianapolis, Indiana, 46202, United States
Delta Research Partners
Bastrop, Louisiana, 71220, United States
UPMC Center for Liver Disease
Pittsburgh, Pennsylvania, 15213, United States
Texas Liver Institute
San Antonio, Texas, 78215, United States
Virginia Commonwealth University
Richmond, Virginia, 23298, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Arun J Sanyal, MD
Virginia Commonwealth University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 21, 2019
First Posted
November 1, 2019
Study Start
March 30, 2019
Primary Completion
May 20, 2020
Study Completion
June 24, 2020
Last Updated
September 18, 2020
Record last verified: 2020-09