Emricasan, a Caspase Inhibitor, for Treatment of Subjects With Decompensated NASH Cirrhosis
ENCORE-LF
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Emricasan, an Oral Caspase Inhibitor, in Subjects With Decompensated Non-Alcoholic Steatohepatitis (NASH) Cirrhosis
1 other identifier
interventional
210
1 country
76
Brief Summary
This is a multicenter, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of emricasan in improving event-free survival based on a composite clinical endpoint (where all-cause mortality, new decompensation events, and MELD score progression are events) in subjects with decompensated NASH cirrhosis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2017
76 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 20, 2017
CompletedStudy Start
First participant enrolled
June 28, 2017
CompletedFirst Posted
Study publicly available on registry
July 2, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2019
CompletedMarch 19, 2019
March 1, 2019
2.1 years
June 20, 2017
March 15, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Comparison of the effect of emricasan on improving event-free survival relative to placebo, based on a composite clinical endpoint
Baseline - Final Treatment Visit (at least 48 weeks to a max of 120 weeks)
Secondary Outcomes (8)
Improvement in MELD score
Baseline - Final Treatment Visit (at least 48 weeks to a max of 120 weeks)
Improvement in Child-Pugh scores
Baseline - Final Treatment Visit (at least 48 weeks to a max of 120 weeks)
Reduction of the proportion of subjects with MELD score progression
Baseline - Final Treatment Visit (at least 48 weeks to a max of 120 weeks)
Decrease in new decompensation events
Baseline - Final Treatment Visit (at least 48 weeks to a max of 120 weeks)
Decrease in liver transplantation rates
Baseline - Final Treatment Visit (at least 48 weeks to a max of 120 weeks)
- +3 more secondary outcomes
Study Arms (3)
Emricasan (25 mg)
ACTIVE COMPARATOREmricasan 25 mg
Emricasan (5 mg)
ACTIVE COMPARATOREmricasan 5mg
Placebo
PLACEBO COMPARATORMatching placebo
Interventions
Eligibility Criteria
You may qualify if:
- Male or female subjects 18 years or older, able to provide written informed consent and able to understand and willing to comply with the requirements of the study.
- At least one of the following: a) history of variceal hemorrhage (more than 3 months prior to day 1) documented on endoscopy and requiring blood transfusion, b) history of at least moderate ascites (on physical exam or imaging) currently treated with diuretics.
- MELD score ≥12 and ≤20 during screening
- Albumin ≥2.5 g/dL during screening
- Serum creatinine ≤1.5 mg/dL during screening
You may not qualify if:
- Evidence of severe decompensation
- Non-cirrhotic portal hypertension
- Child-Pugh score ≥10
- Current use of anticoagulants that affect prothrombin time or international normalized ratio
- ALT \>3 times upper limit of normal (ULN) or AST \>5 times ULN during screening
- Initiation or discontinuation of non-selective beta blockers within 1 month of screening
- Transjugular intrahepatic portosystemic shunt or other porto-systemic bypass procedure within 1 year of screening or previously requiring revision
- Alpha-fetoprotein \>50 ng/mL in the last year
- History of hepatocellular carcinoma (HCC) or evidence of HCC
- History of malignancies other than HCC, unless successfully treated with curative intent and believed to be cured
- Prior liver transplant
- Uncontrolled diabetes mellitus (HbA1c \>9%)
- Change in diabetes medications or vitamin E within 3 months of screening
- Restrictive bariatric surgery or bariatric device within 1 year of screening or prior malabsorptive bariatric surgery
- Symptoms of biliary colic unless resolved following cholecystectomy
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (76)
The Institute for Liver Health
Chandler, Arizona, 85224, United States
St. Joseph's Hospital & Medical Center
Phoenix, Arizona, 85013, United States
Mayo Clinic Arizona
Phoenix, Arizona, 85054, United States
University of Arizona Liver Research Institute
Tucson, Arizona, 85747, United States
University of California, San Francisco-Fresno
Fresno, California, 93701, United States
Cedars Sinai Medical Center
Los Angeles, California, 90048, United States
UCLA Pfleger Liver Institute
Los Angeles, California, 90095, United States
California Liver Research Institute
Pasadena, California, 91105, United States
Stanford University
Redwood City, California, 94063, United States
Inland Empire Liver Foundation
Rialto, California, 92377, United States
UC Davis GI/Hepatology Clinical Trials Unit
Sacramento, California, 95817, United States
Scripps Clinic - Torrey Pines
San Diego, California, 92037, United States
California Pacific Medical Center
San Francisco, California, 94115, United States
University of California San Francisco
San Francisco, California, 94143, United States
University of Colorado Denver
Aurora, Colorado, 80045, United States
Peak Enterology Associates
Colorado Springs, Colorado, 80907, United States
West Haven VA Medical Center
West Haven, Connecticut, 06516, United States
UF Hepatology Research at CTRB
Gainesville, Florida, 32610, United States
Mayo Clinic
Jacksonville, Florida, 32224, United States
Florida Research Institute
Lakewood Rch, Florida, 34211, United States
Schiff Center for Liver Disease/University of Miami
Miami, Florida, 33136, United States
Florida Hospital Transplant Institute
Orlando, Florida, 32804, United States
IMIC Inc.
Palmetto Bay, Florida, 33157, United States
Tampa General Hospital
Tampa, Florida, 33606, United States
Piedmont Transplant Institute
Atlanta, Georgia, 30309, United States
Gastrointestinal Specialists of Georgia
Marietta, Georgia, 30060, United States
Northwestern University
Chicago, Illinois, 60611, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
Aquiant Research
Albany, Indiana, 47150, United States
Indiana University
Indianapolis, Indiana, 46202, United States
University of Iowa Hospitals and Clinics/ Internal Medicine
Iowa City, Iowa, 52242, United States
Delta Research Partners
Bastrop, Louisiana, 71220, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121, United States
Mercy Medical Center
Baltimore, Maryland, 21202, United States
Walter Reed National Military Medical Center (WRNMMC)
Bethesda, Maryland, 20889, United States
Digestive Disease Associates, PA
Catonsville, Maryland, 21228, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Mayo Clinic
Rochester, Minnesota, 55901, United States
University of Mississippi Medical Center, Division of Digestive Diseases
Jackson, Mississippi, 39216, United States
Kansas City Research Institute
Kansas City, Missouri, 64131, United States
Rutgers New Jersey Medical School
Newark, New Jersey, 07103, United States
Northwell Health Inc., Sandra Atlas Bass Center for Liver Diseases.
Manhasset, New York, 11030, United States
NYU Medical Center
New York, New York, 10016, United States
Weill Cornell Medical College
New York, New York, 10021, United States
Columbia University Medical Center - Center for Liver Disease and Transplantation
New York, New York, 10032, United States
University of Rochester Medical Center
Rochester, New York, 14642, United States
Carolinas Healthcare System, Center for Liver Disease
Charlotte, North Carolina, 28204, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Diabetes & Endocrinology Consultants, PC
Morehead City, North Carolina, 28557, United States
UC Health/ UCPC LLC
Cincinnati, Ohio, 45267, United States
Options Health Research, LLC
Tulsa, Oklahoma, 74104, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
GHS Gastroenterology and Liver Center
Greenville, South Carolina, 29605, United States
ClinSearch, LLC
Chattanooga, Tennessee, 37421, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Texas Clinical Research Institute
Arlington, Texas, 76012, United States
Methodist Health System Clinical Research Institute
Dallas, Texas, 75203, United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
Baylor Scott & White Research Institute
Fort Worth, Texas, 76104, United States
Baylor College of Medicine - Advanced Liver Therapies
Houston, Texas, 77030, United States
Liver Associates of Texas, P.A.
Houston, Texas, 77030, United States
American Research Corporation at the Texas Liver Institue
San Antonio, Texas, 78215, United States
Methodist Specialty & Transplant Hospital
San Antonio, Texas, 78229, United States
San Antonio Military Medical Center
San Antonio, Texas, 78234, United States
University of Utah
Salt Lake City, Utah, 84132, United States
University of Virginia
Charlottesville, Virginia, 22908, United States
Emeritas Research Group LLC
Leesburg, Virginia, 20176, United States
Banner University Medical Center - Phoenix Transplant Institute
Newport News, Virginia, 23602, United States
Bon Secours Liver Institute of Virginia
Richmond, Virginia, 23226, United States
Virginia Commonwealth University
Richmond, Virginia, 23298, United States
Swedish Organ Transplant and Liver Center
Seattle, Washington, 98104, United States
University of Washington Harborview Medical Center
Seattle, Washington, 98104, United States
University of Washington
Seattle, Washington, 98195, United States
Related Publications (1)
Frenette C, Kayali Z, Mena E, Mantry PS, Lucas KJ, Neff G, Rodriguez M, Thuluvath PJ, Weinberg E, Bhandari BR, Robinson J, Wedick N, Chan JL, Hagerty DT, Kowdley KV; IDN-6556-17 Study Investigators. Emricasan to prevent new decompensation in patients with NASH-related decompensated cirrhosis. J Hepatol. 2021 Feb;74(2):274-282. doi: 10.1016/j.jhep.2020.09.029. Epub 2020 Oct 8.
PMID: 33038432DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jean L Chan, MD
Conatus Pharmaceuticals Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Study drug will be double-blind with matching placebo. Emricasan at 25 mg or 5 mg or matching placebo will be administered orally twice a day.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 20, 2017
First Posted
July 2, 2017
Study Start
June 28, 2017
Primary Completion
August 1, 2019
Study Completion
August 1, 2019
Last Updated
March 19, 2019
Record last verified: 2019-03
Data Sharing
- IPD Sharing
- Will not share