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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04147936
Other study ID # AXA1665-002
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 30, 2019
Est. completion date June 24, 2020

Study information

Verified date September 2020
Source Axcella Health, Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date June 24, 2020
Est. primary completion date May 20, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
AXA1665
Dietary supplement: AXA1665
Placebo
Placebo

Locations

Country Name City State
United States Atlanta Center for Medical Research Atlanta Georgia
United States Delta Research Partners Bastrop Louisiana
United States Indiana University Health Indianapolis Indiana
United States Panax Clinical Research Miami Lakes Florida
United States Catalina Research Institute, LLC Montclair California
United States OMEGA Research Maitland, LCC Orlando Florida
United States UPMC Center for Liver Disease Pittsburgh Pennsylvania
United States Virginia Commonwealth University Richmond Virginia
United States Texas Liver Institute San Antonio Texas
United States Avita Clinical Research Tampa Florida
United States Orange County Research Center Tustin California

Sponsors (1)

Lead Sponsor Collaborator
Axcella Health, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of study product emergent adverse events (AEs) and serious adverse events (SAEs) Baseline to Week 12
Secondary Change in muscle mass by MRI Baseline to Week 12
Secondary 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
Secondary Change in plasma ammonia Baseline to Week 12
Secondary Change in blood urea nitrogen concentration Baseline to Week 12
Secondary Change in creatinine concentration Baseline to Week 12
Secondary Change in gait speed Baseline to Week 12
Secondary Change in Liver Frailty Index Baseline to Week 12
Secondary Change in overall physical activity (measured by actigraphy watch) Baseline to Week 12
Secondary Change in cognitive function measured by the Psychometric Hepatic Encephalopathy Score (PHES) Baseline to Week 12
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