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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AXA1665 29.4g | Active Comparator | Dietary Supplement: AXA1665 Amino acids, food study |
|
| AXA1665 53.9 g | Active Comparator | Dietary Supplement: AXA1665 Amino acids, food study |
|
| Placebo 29.4 g | Placebo Comparator | Dietary Supplement: Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AXA1665 | Dietary Supplement | Dietary supplement: AXA1665 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of study product emergent adverse events (AEs) and serious adverse events (SAEs) | Baseline to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Arun J Sanyal, MD | Virginia Commonwealth University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Catalina Research Institute, LLC | Montclair | California | 91762 | United States | ||
| Orange County Research Center |
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| Placebo |
| Dietary Supplement |
Placebo |
|
| 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 |
| Change in gait speed | 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 |
| 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 |
| ID | Term |
|---|---|
| D048550 | Hepatic Insufficiency |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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