Study of the Safety and Tolerability of AXA1665 in Subjects With Mild and Moderate Hepatic Insufficiency
Public ClinicalTrials.gov record NCT04147936. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT04147936
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 60 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 30, 2019 (Actual)
- Primary completion
- May 20, 2020 (Actual)
- Completion
- Jun 24, 2020 (Actual)
- Last update posted
- Sep 18, 2020
2019 – 2020
United States locations
- U.S. sites
- 11
- U.S. states
- 8
- U.S. cities
- 11
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Catalina Research Institute, LLC | Montclair | California | 91762 | — |
| Orange County Research Center | Tustin | California | 92780 | — |
| Panax Clinical Research | Miami Lakes | Florida | 33014 | — |
| OMEGA Research Maitland, LCC | Orlando | Florida | 32810 | — |
| Avita Clinical Research | Tampa | Florida | 33613 | — |
| Atlanta Center for Medical Research | Atlanta | Georgia | 30331 | — |
| Indiana University Health | Indianapolis | Indiana | 46202 | — |
| Delta Research Partners | Bastrop | Louisiana | 71220 | — |
| UPMC Center for Liver Disease | Pittsburgh | Pennsylvania | 15213 | — |
| Texas Liver Institute | San Antonio | Texas | 78215 | — |
| Virginia Commonwealth University | Richmond | Virginia | 23298 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04147936, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 18, 2020 · Synced Oct 23, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04147936 live on ClinicalTrials.gov.