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Clinical Trials/NCT04147936
NCT04147936CompletedNot Applicable

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

Axcella Health, Inc11 sites in 1 country60 target enrollmentStarted: March 30, 2019Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
60
Locations
11
Primary Endpoint
Incidence of study product emergent adverse events (AEs) and serious adverse events (SAEs)
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Basic Science
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
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
  • •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

  • •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

Arms & Interventions

Placebo 29.4 g

Placebo Comparator

Dietary Supplement: Placebo

Intervention: Placebo (Dietary Supplement)

AXA1665 53.9 g

Active Comparator

Dietary Supplement: AXA1665 Amino acids, food study

Intervention: AXA1665 (Dietary Supplement)

AXA1665 29.4g

Active Comparator

Dietary Supplement: AXA1665 Amino acids, food study

Intervention: AXA1665 (Dietary Supplement)

Outcomes

Primary Outcomes

Incidence of study product emergent adverse events (AEs) and serious adverse events (SAEs)

Time Frame: Baseline to Week 12

Secondary Outcomes

  • Change in blood urea nitrogen concentration(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 muscle mass by MRI(Baseline to Week 12)
  • Change in plasma ammonia(Baseline to Week 12)
  • Change in Liver Frailty Index(Baseline to Week 12)
  • Change in overall physical activity (measured by actigraphy watch)(Baseline to Week 12)
  • Change in cognitive function measured by the Psychometric Hepatic Encephalopathy Score (PHES)(Baseline to Week 12)
  • Change in creatinine concentration(Baseline to Week 12)
  • Change in gait speed(Baseline to Week 12)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (11)

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