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

• Sponsor: Axcella Health, Inc (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04147936
• Collaborator: (none)
• Enrollment: 60
• Locations: 11
• Arms: 3
• Actual Duration (Months): 14.9
• Patients Per Site: 5.5
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatic Insufficiency	Dietary Supplement: AXA1665; Dietary Supplement: Placebo	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Basic Science
• 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
• Actual Study Start Date: Mar 30, 2019
• Actual Primary Completion Date: May 20, 2020
• Actual Study Completion Date: Jun 24, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: AXA1665 29.4g Dietary Supplement: AXA1665 Amino acids, food study	Dietary Supplement: AXA1665; Dietary supplement: AXA1665
Active Comparator: AXA1665 53.9 g Dietary Supplement: AXA1665 Amino acids, food study	Dietary Supplement: AXA1665; Dietary supplement: AXA1665
Placebo Comparator: Placebo 29.4 g Dietary Supplement: Placebo	Dietary Supplement: Placebo; Placebo

Outcome Measures

Primary Outcome Measures

1. Incidence of study product emergent adverse events (AEs) and serious adverse events (SAEs) [Baseline to Week 12]

Secondary Outcome Measures

1. Change in muscle mass by MRI [Baseline to Week 12]

2. 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]

3. Change in plasma ammonia [Baseline to Week 12]

4. Change in blood urea nitrogen concentration [Baseline to Week 12]

5. Change in creatinine concentration [Baseline to Week 12]

6. Change in gait speed [Baseline to Week 12]

7. Change in Liver Frailty Index [Baseline to Week 12]

8. Change in overall physical activity (measured by actigraphy watch) [Baseline to Week 12]

9. Change in cognitive function measured by the Psychometric Hepatic Encephalopathy Score (PHES) [Baseline to Week 12]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Catalina Research Institute, LLC	Montclair	California	United States	91762
2	Orange County Research Center	Tustin	California	United States	92780
3	Panax Clinical Research	Miami Lakes	Florida	United States	33014
4	OMEGA Research Maitland, LCC	Orlando	Florida	United States	32810
5	Avita Clinical Research	Tampa	Florida	United States	33613
6	Atlanta Center for Medical Research	Atlanta	Georgia	United States	30331
7	Indiana University Health	Indianapolis	Indiana	United States	46202
8	Delta Research Partners	Bastrop	Louisiana	United States	71220
9	UPMC Center for Liver Disease	Pittsburgh	Pennsylvania	United States	15213
10	Texas Liver Institute	San Antonio	Texas	United States	78215
11	Virginia Commonwealth University	Richmond	Virginia	United States	23298

Sponsors and Collaborators

• Axcella Health, Inc

Investigators

• Principal Investigator: Arun J Sanyal, MD, Virginia Commonwealth University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Axcella Health, Inc
• ClinicalTrials.gov Identifier: NCT04147936
• Other Study ID Numbers: AXA1665-002
• First Posted: Nov 1, 2019
• Last Update Posted: Sep 18, 2020
• Last Verified: Sep 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Axcella Health, Inc: Amino acids, food study
• Additional relevant MeSH terms: Hepatic Insufficiency; Liver Failure

Study Results

No Results Posted as of Sep 18, 2020