Study of the Safety and Tolerability of AXA1665 in Subjects With Mild and Moderate Hepatic Insufficiency

Hepatic Insufficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04147936
• Other study ID #: AXA1665-002
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Hepatic Insufficiency
• Liver Failure

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