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NCT04147936 · ClinicalTrials.gov registry record · NA
Study of the Safety and Tolerability of AXA1665 in Subjects With Mild and Moderate Hepatic Insufficiency
A NA study of Hepatic Insufficiency, sponsored by Axcella Health.
- Completed
- Registry status
- NA
- Development phase
- 60
- Enrollment target
- 11
- Study locations
NCT04147936: Completed NA study of Hepatic Insufficiency, sponsored by Axcella Health.
NCT04147936 is a NA study of Hepatic Insufficiency that has completed, run by Axcella Health. The registered enrollment target is 60 participants, above the 36-participant average among 14 other Hepatic Insufficiency trials with a reported enrollment target (67% higher). The trial reports 11 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04147936, a NA study of Hepatic Insufficiency, has completed, sponsored by Axcella Health.
- COMPLETED
- Registry status
- NA
- Development phase
- 60 participants
- Enrollment target
- 11
- Study locations
Study 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.
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT Placebo
- DIETARY_SUPPLEMENT AXA1665
Study Locations (11)
Florida
- Panax Clinical Research - Miami Lakes
- OMEGA Research Maitland, LCC - Orlando
- Avita Clinical Research - Tampa
California
- Catalina Research Institute, LLC - Montclair
- Orange County Research Center - Tustin
Georgia
- Atlanta Center for Medical Research - Atlanta
Indiana
- Indiana University Health - Indianapolis
Louisiana
- Delta Research Partners - Bastrop
Pennsylvania
- UPMC Center for Liver Disease - Pittsburgh
Texas
- Texas Liver Institute - San Antonio
Virginia
- Virginia Commonwealth University - Richmond
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2019-03-30 |
| Est. Completion | 2020-06-24 |
| Phase | NA |
What the finished NCT04147936 record still lists
NCT04147936 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, above the 36-participant average among 14 other Hepatic Insufficiency trials with a reported enrollment target (67% higher).
The record links to 1 condition, with Hepatic Insufficiency appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04147936 lists 11 locations in 8 states (Florida, California, Georgia).
Frequently Asked Questions
What is clinical trial NCT04147936 about?
NCT04147936 is a clinical study titled "Study of the Safety and Tolerability of AXA1665 in Subjects With Mild and Moderate Hepatic Insufficiency". 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 ...
What is the current status of trial NCT04147936?
This trial is currently completed. It is a NA study. The enrollment target is 60 participants. The study started on 2019-03-30. Estimated completion is 2020-06-24.
What conditions does trial NCT04147936 study?
This clinical trial studies the following conditions: Hepatic Insufficiency.
What interventions are being tested in trial NCT04147936?
The interventions under investigation include: Placebo (DIETARY_SUPPLEMENT), AXA1665 (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT04147936?
This trial is sponsored by Axcella Health, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04147936 being conducted?
This trial has 11 study locations across California, Florida, Georgia, Indiana, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Hepatic Insufficiency
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04147936's enrollment target sits among peer trials
60 1st of 14 higher than 14 of 14 other Hepatic Insufficiency trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hepatic Insufficiency trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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