A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Emricasan, an Oral Caspase Inhibitor, in Subjects With Decompensated Non-Alcoholic Steatohepatitis (NASH) Cirrhosis

Who is this study for? Patients with decompensated non-alcoholic steatohepatitis cirrhosis
What treatments are being studied? Emricasan
Status: Unknown status
Location: See all (76) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• 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.

• Cirrhosis due to NASH with exclusion of other causes of cirrhosis (e.g. chronic viral hepatitis, alcoholic liver disease, etc.)

• 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

Locations
United States
Arizona
The Institute for Liver Health
Chandler
Mayo Clinic Arizona
Phoenix
St. Joseph's Hospital & Medical Center
Phoenix
University of Arizona Liver Research Institute
Tucson
California
University of California, San Francisco-Fresno
Fresno
Cedars Sinai Medical Center
Los Angeles
UCLA Pfleger Liver Institute
Los Angeles
California Liver Research Institute
Pasadena
Stanford University
Redwood City
Inland Empire Liver Foundation
Rialto
UC Davis GI/Hepatology Clinical Trials Unit
Sacramento
Scripps Clinic - Torrey Pines
San Diego
California Pacific Medical Center
San Francisco
University of California San Francisco
San Francisco
Colorado
University of Colorado Denver
Aurora
Peak Enterology Associates
Colorado Springs
Connecticut
West Haven VA Medical Center
West Haven
Florida
UF Hepatology Research at CTRB
Gainesville
Mayo Clinic
Jacksonville
Florida Research Institute
Lakewood Ranch
Schiff Center for Liver Disease/University of Miami
Miami
Florida Hospital Transplant Institute
Orlando
IMIC Inc.
Palmetto Bay
Tampa General Hospital
Tampa
Georgia
Piedmont Transplant Institute
Atlanta
Gastrointestinal Specialists of Georgia
Marietta
Iowa
University of Iowa Hospitals and Clinics/ Internal Medicine
Iowa City
Illinois
Northwestern University
Chicago
Rush University Medical Center
Chicago
Indiana
Aquiant Research
Albany
Indiana University
Indianapolis
Louisiana
Delta Research Partners
Bastrop
Ochsner Clinic Foundation
New Orleans
Massachusetts
Beth Israel Deaconess Medical Center
Boston
Massachusetts General Hospital
Boston
Maryland
Mercy Medical Center
Baltimore
Walter Reed National Military Medical Center (WRNMMC)
Bethesda
Digestive Disease Associates, PA
Catonsville
Michigan
Henry Ford Health System
Detroit
Minnesota
Mayo Clinic
Rochester
Missouri
Kansas City Research Institute
Kansas City
Mississippi
University of Mississippi Medical Center, Division of Digestive Diseases
Jackson
North Carolina
Carolinas Healthcare System, Center for Liver Disease
Charlotte
Duke University Medical Center
Durham
Diabetes & Endocrinology Consultants, PC
Morehead City
New Jersey
Rutgers New Jersey Medical School
Newark
New York
Northwell Health Inc., Sandra Atlas Bass Center for Liver Diseases.
Manhasset
Columbia University Medical Center - Center for Liver Disease and Transplantation
New York
NYU Medical Center
New York
Weill Cornell Medical College
New York
University of Rochester Medical Center
Rochester
Ohio
UC Health/ UCPC LLC
Cincinnati
Oklahoma
Options Health Research, LLC
Tulsa
Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia
South Carolina
Medical University of South Carolina
Charleston
GHS Gastroenterology and Liver Center
Greenville
Tennessee
ClinSearch, LLC
Chattanooga
Vanderbilt University Medical Center
Nashville
Texas
Texas Clinical Research Institute
Arlington
Methodist Health System Clinical Research Institute
Dallas
University of Texas Southwestern Medical Center
Dallas
Baylor Scott & White Research Institute
Fort Worth
Baylor College of Medicine - Advanced Liver Therapies
Houston
Liver Associates of Texas, P.A.
Houston
American Research Corporation at the Texas Liver Institue
San Antonio
Methodist Specialty & Transplant Hospital
San Antonio
San Antonio Military Medical Center
San Antonio
Utah
University of Utah
Salt Lake City
Virginia
University of Virginia
Charlottesville
Emeritas Research Group LLC
Leesburg
Banner University Medical Center - Phoenix Transplant Institute
Newport News
Bon Secours Liver Institute of Virginia
Richmond
Virginia Commonwealth University
Richmond
Washington
Swedish Organ Transplant and Liver Center
Seattle
University of Washington
Seattle
University of Washington Harborview Medical Center
Seattle
Time Frame
Start Date: June 28, 2017
Completion Date: August 2019
Participants
Target number of participants: 210
Treatments
Active Comparator: Emricasan (25 mg)
Emricasan 25 mg
Active Comparator: Emricasan (5 mg)
Emricasan 5mg
Placebo Comparator: Placebo
Matching placebo
Sponsors
Leads: Conatus Pharmaceuticals Inc.

This content was sourced from clinicaltrials.gov

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