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NCT02686762 · ClinicalTrials.gov registry record · Phase 2
Emricasan, a Caspase Inhibitor, for Evaluation in Subjects With Non-Alcoholic Steatohepatitis (NASH) Fibrosis
A Phase 2 study of Liver Diseases and Nonalcoholic Steatohepatitis, sponsored by Conatus Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 318
- Enrollment target
- 20
- Study locations
NCT02686762: Completed Phase 2 study of Liver Diseases and Nonalcoholic Steatohepatitis, sponsored by Conatus Pharmaceuticals.
NCT02686762 is a Phase 2 study of Liver Diseases and Nonalcoholic Steatohepatitis that has completed, run by Conatus Pharmaceuticals. The registered enrollment target is 318 participants, below the 61,149-participant average among 33 other Liver Diseases trials with a reported enrollment target (99% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02686762, a Phase 2 study of Liver Diseases and Nonalcoholic Steatohepatitis, has completed, sponsored by Conatus Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 318 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a multicenter, double-blind, randomized, placebo-controlled trial involving subjects with a diagnosis of "definite NASH" with fibrosis (excluding cirrhosis) as determined by the central histopathologist. Upon successful screening, subjects will be randomized to receive either emricasan 50 mg BID or emricasan 5 mg BID or matching placebo BID.
Primary Outcome
Proportion of subjects who improve fibrosis on liver biopsy by at least one stage without worsening of steatohepatitis in the emricasan group compared to placebo
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Emricasan (5 mg)
- DRUG Emricasan (50 mg)
Study Locations (20)
California
- Fresno Clinical Research Center - Freestone
- UCLA The Pfleger Liver Institute - Los Angeles
- Gastrointestinal Biosciences - Los Angeles
- Surinder Singh Saini, M.D., Inc. - Newport Beach
- California Liver Research Institute - Pasadena
- Inland Empire Liver Foundation - Rialto
- University of California Davis Medical Center - Sacramento
- University of California San Diego Medical Center - San Diego
- Cedars Sinai Medical Center - West Hollywood
Florida
- UF Hepatology Research at CTRB - Gainesville
- Florida Digestive Health Specialist - Lakewood Rch
- Miami Veterans Administration Healthcare System - Miami
- University of Miami/Schiff Center for Liver Diseases - Miami
- Florida Hospital Orlando Transplant Institute - Orlando
District of Columbia
- Sibley Memorial Hospital - Washington D.C.
- Howard University - Washington D.C.
Alabama
- University of Alabama at Birmingham - Birmingham
Arizona
- University of Arizona Clinical and Translational Sciences Research Center - Tucson
Arkansas
- Preferred Research Partners, Inc. - Little Rock
Connecticut
- Yale University School of Medicine - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 318 participants |
| Start Date | 2016-01-26 |
| Est. Completion | 2019-02-28 |
| Phase | Phase 2 |
What the finished NCT02686762 record still lists
NCT02686762 is an interventional study that assigns participants to a tested intervention. The registered 318 participants enrollment target is mid-sized for trials with a published cap, below the 61,149-participant average among 33 other Liver Diseases trials with a reported enrollment target (99% lower).
The record links to 3 conditions, with Liver Diseases appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT02686762 names 20 study sites across 7 states, led by California, Florida, District of Columbia.
Frequently Asked Questions
What is clinical trial NCT02686762 about?
NCT02686762 is a clinical study titled "Emricasan, a Caspase Inhibitor, for Evaluation in Subjects With Non-Alcoholic Steatohepatitis (NASH) Fibrosis". This is a multicenter, double-blind, randomized, placebo-controlled trial involving subjects with a diagnosis of "definite NASH" with fibrosis (excluding cirrhosis) as determined by the central histopathologist. Upon successful screening, subjects will be randomized to receive either emricasan 50 mg...
What is the current status of trial NCT02686762?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 318 participants. The study started on 2016-01-26. Estimated completion is 2019-02-28.
What conditions does trial NCT02686762 study?
This clinical trial studies the following conditions: Liver Diseases, Nonalcoholic Steatohepatitis, Fibrosis.
What interventions are being tested in trial NCT02686762?
The interventions under investigation include: Placebo (DRUG), Emricasan (5 mg) (DRUG), Emricasan (50 mg) (DRUG).
Who is sponsoring clinical trial NCT02686762?
This trial is sponsored by Conatus Pharmaceuticals, which has 16 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02686762 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT02686762's enrollment target sits among peer trials
318 13th of 33 higher than 21 of 33 other Liver Diseases trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Liver Diseases 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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