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NCT02316717 · ClinicalTrials.gov registry record · Phase 2
A Phase ll Study of IMM-124E for Patients With Non-alcoholic Steatohepatitis
A Phase 2 study of Non-alcoholic Steatohepatitis (NASH), sponsored by Immuron.
- Completed
- Registry status
- Phase 2
- Development phase
- 133
- Enrollment target
- 20
- Study locations
NCT02316717: Completed Phase 2 study of Non-alcoholic Steatohepatitis (NASH), sponsored by Immuron.
NCT02316717 is a Phase 2 study of Non-alcoholic Steatohepatitis (NASH) that has completed, run by Immuron. The registered enrollment target is 133 participants, below the 188-participant average among 16 other Non-alcoholic Steatohepatitis (NASH) trials with a reported enrollment target (29% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02316717, a Phase 2 study of Non-alcoholic Steatohepatitis (NASH), has completed, sponsored by Immuron.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 133 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study will evaluate the safety and preliminary efficacy of two dose levels of IMM-124E in reducing liver fat and/or serum alanine aminotransaminase (ALT) compared with placebo.
Primary Outcome
Incidence of adverse events per arm/group
Conditions Studied
Interventions
- OTHER Placebo
- BIOLOGICAL IMM-124E
Study Locations (20)
Virginia
- University of Virginia Medical Centre - Charlottesville
- Mary Immaculate Hospital - Newport News
- Bon Secours St Marys Hospital - Richmond
- Virginia Commonwealth University - Richmond
California
- eStudySite - Chula Vista
- University of California San Diego - San Diego
- Quest Clinical Research - San Francisco
Texas
- Baylor St Lukes Medical Centre - Houston
- Brooke Army Medical Centre - Houston
- Pinnacle Clinical Research - Live Oak
New South Wales
- The Nepean Hospital - Penrith
- Westmead Hospital - Westmead
Colorado
- University of Colorado - Aurora
Florida
- University of Florida Hepatology Research at CTRB - Gainesville
Illinois
- Northwestern Memorial Hospital - Chicago
Missouri
- Kansas City Research Institute - Kansas City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 133 participants |
| Start Date | 2014-12 |
| Est. Completion | 2017-10-30 |
| Phase | Phase 2 |
What the finished NCT02316717 record still lists
NCT02316717 is an interventional study that assigns participants to a tested intervention. The registered 133 participants enrollment target is mid-sized for trials with a published cap, below the 188-participant average among 16 other Non-alcoholic Steatohepatitis (NASH) trials with a reported enrollment target (29% lower).
The record links to 1 condition, with Non-alcoholic Steatohepatitis (NASH) appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02316717 names 20 study sites across 12 states, led by Virginia, California, Texas.
Frequently Asked Questions
What is clinical trial NCT02316717 about?
NCT02316717 is a clinical study titled "A Phase ll Study of IMM-124E for Patients With Non-alcoholic Steatohepatitis". This study will evaluate the safety and preliminary efficacy of two dose levels of IMM-124E in reducing liver fat and/or serum alanine aminotransaminase (ALT) compared with placebo.
What is the current status of trial NCT02316717?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 133 participants. The study started on 2014-12. Estimated completion is 2017-10-30.
What conditions does trial NCT02316717 study?
This clinical trial studies the following conditions: Non-alcoholic Steatohepatitis (NASH).
What interventions are being tested in trial NCT02316717?
The interventions under investigation include: Placebo (OTHER), IMM-124E (BIOLOGICAL).
Who is sponsoring clinical trial NCT02316717?
This trial is sponsored by Immuron, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02316717 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Illinois, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT02316717's enrollment target sits among peer trials
133 8th of 16 higher than 9 of 16 other Non-alcoholic Steatohepatitis (NASH) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-alcoholic Steatohepatitis (NASH) 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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