search
Back to results

Emricasan, a Caspase Inhibitor, for Treatment of Subjects With Decompensated NASH Cirrhosis (ENCORE-LF)

Primary Purpose

Decompensated Cirrhosis

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Emricasan (25 mg)
Emricasan (5 mg)
Placebo
Sponsored by
Conatus Pharmaceuticals Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Decompensated Cirrhosis focused on measuring Cirrhosis, NASH Cirrhosis, Decompensated NASH cirrhosis, Cirrhosis, Liver, Non-Alcoholic Fatty Liver Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

  1. 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.
  2. Cirrhosis due to NASH with exclusion of other causes of cirrhosis (e.g. chronic viral hepatitis, alcoholic liver disease, etc.)
  3. 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.
  4. MELD score ≥12 and ≤20 during screening
  5. Albumin ≥2.5 g/dL during screening
  6. Serum creatinine ≤1.5 mg/dL during screening

Key Exclusion Criteria:

  1. Evidence of severe decompensation
  2. Non-cirrhotic portal hypertension
  3. Child-Pugh score ≥10
  4. Current use of anticoagulants that affect prothrombin time or international normalized ratio
  5. ALT >3 times upper limit of normal (ULN) or AST >5 times ULN during screening
  6. Initiation or discontinuation of non-selective beta blockers within 1 month of screening
  7. Transjugular intrahepatic portosystemic shunt or other porto-systemic bypass procedure within 1 year of screening or previously requiring revision
  8. Alpha-fetoprotein >50 ng/mL in the last year
  9. History of hepatocellular carcinoma (HCC) or evidence of HCC
  10. History of malignancies other than HCC, unless successfully treated with curative intent and believed to be cured
  11. Prior liver transplant
  12. Uncontrolled diabetes mellitus (HbA1c >9%)
  13. Change in diabetes medications or vitamin E within 3 months of screening
  14. Restrictive bariatric surgery or bariatric device within 1 year of screening or prior malabsorptive bariatric surgery
  15. Symptoms of biliary colic unless resolved following cholecystectomy
  16. History of significant alcohol consumption within the past 5 years
  17. Current use of medications that are considered inhibitors of organic anion transporting polypeptide OATP1B1 and OATP1B3 transporters
  18. Prolongation of screening (pre-treatment) QTcF interval of >500 msecs, or history or presence of clinically concerning cardiac arrhythmias
  19. Significant systemic or major illness other than liver disease
  20. Human immunodeficiency virus infection
  21. Use of alcohol, controlled substances (including inhaled or injected drugs), or non-prescribed use of prescription drugs within 1 year of screening to the point of interfering with the subject's ability to comply with study procedures and study drug administration in the investigator's judgement

Sites / Locations

  • The Institute for Liver Health
  • St. Joseph's Hospital & Medical Center
  • Mayo Clinic Arizona
  • University of Arizona Liver Research Institute
  • University of California, San Francisco-Fresno
  • Cedars Sinai Medical Center
  • UCLA Pfleger Liver Institute
  • California Liver Research Institute
  • Stanford University
  • Inland Empire Liver Foundation
  • UC Davis GI/Hepatology Clinical Trials Unit
  • Scripps Clinic - Torrey Pines
  • California Pacific Medical Center
  • University of California San Francisco
  • University of Colorado Denver
  • Peak Enterology Associates
  • West Haven VA Medical Center
  • UF Hepatology Research at CTRB
  • Mayo Clinic
  • Florida Research Institute
  • Schiff Center for Liver Disease/University of Miami
  • Florida Hospital Transplant Institute
  • IMIC Inc.
  • Tampa General Hospital
  • Piedmont Transplant Institute
  • Gastrointestinal Specialists of Georgia
  • Northwestern University
  • Rush University Medical Center
  • Aquiant Research
  • Indiana University
  • University of Iowa Hospitals and Clinics/ Internal Medicine
  • Delta Research Partners
  • Ochsner Clinic Foundation
  • Mercy Medical Center
  • Walter Reed National Military Medical Center (WRNMMC)
  • Digestive Disease Associates, PA
  • Massachusetts General Hospital
  • Beth Israel Deaconess Medical Center
  • Henry Ford Health System
  • Mayo Clinic
  • University of Mississippi Medical Center, Division of Digestive Diseases
  • Kansas City Research Institute
  • Rutgers New Jersey Medical School
  • Northwell Health Inc., Sandra Atlas Bass Center for Liver Diseases.
  • NYU Medical Center
  • Weill Cornell Medical College
  • Columbia University Medical Center - Center for Liver Disease and Transplantation
  • University of Rochester Medical Center
  • Carolinas Healthcare System, Center for Liver Disease
  • Duke University Medical Center
  • Diabetes & Endocrinology Consultants, PC
  • UC Health/ UCPC LLC
  • Options Health Research, LLC
  • Hospital of the University of Pennsylvania
  • Medical University of South Carolina
  • GHS Gastroenterology and Liver Center
  • ClinSearch, LLC
  • Vanderbilt University Medical Center
  • Texas Clinical Research Institute
  • Methodist Health System Clinical Research Institute
  • University of Texas Southwestern Medical Center
  • Baylor Scott & White Research Institute
  • Baylor College of Medicine - Advanced Liver Therapies
  • Liver Associates of Texas, P.A.
  • American Research Corporation at the Texas Liver Institue
  • Methodist Specialty & Transplant Hospital
  • San Antonio Military Medical Center
  • University of Utah
  • University of Virginia
  • Emeritas Research Group LLC
  • Banner University Medical Center - Phoenix Transplant Institute
  • Bon Secours Liver Institute of Virginia
  • Virginia Commonwealth University
  • Swedish Organ Transplant and Liver Center
  • University of Washington Harborview Medical Center
  • University of Washington

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Emricasan (25 mg)

Emricasan (5 mg)

Placebo

Arm Description

Emricasan 25 mg

Emricasan 5mg

Matching placebo

Outcomes

Primary Outcome Measures

Comparison of the effect of emricasan on improving event-free survival relative to placebo, based on a composite clinical endpoint

Secondary Outcome Measures

Improvement in MELD score
The effect of emricasan on improving MELD score relative to placebo
Improvement in Child-Pugh scores
The effect of emricasan on improving the Child-Pugh score relative to placebo
Reduction of the proportion of subjects with MELD score progression
The effect of emricasan on reducing the proportion of patients with MELD score progression (≥4 point increase at any study visit) relative to placebo
Decrease in new decompensation events
The effect of emricasan on decreasing new decompensation events relative to placebo
Decrease in liver transplantation rates
The effect of emricasan on decreasing liver transplantation rates (in association with MELD score ≥25) relative to placebo
Decrease in all-cause and liver specific mortality
The effect of emricasan on decreasing all-cause and liver specific mortality relative to placebo
Improvement in health-related quality of life (QOL) as measured by Short Form-36
Improvement in liver metabolic function as measured by Methacetin Breath Test (MBT)

Full Information

First Posted
June 20, 2017
Last Updated
March 15, 2019
Sponsor
Conatus Pharmaceuticals Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT03205345
Brief Title
Emricasan, a Caspase Inhibitor, for Treatment of Subjects With Decompensated NASH Cirrhosis
Acronym
ENCORE-LF
Official Title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Emricasan, an Oral Caspase Inhibitor, in Subjects With Decompensated Non-Alcoholic Steatohepatitis (NASH) Cirrhosis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 28, 2017 (Actual)
Primary Completion Date
August 2019 (Anticipated)
Study Completion Date
August 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Conatus Pharmaceuticals Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
The study treatment duration will be at least 48 weeks with study visits every 4 weeks up to Week 48 and every 8 weeks after Week 48. All subjects will continue treatment until the last subject in the study reaches 48 weeks in the study. At least 30% of subjects randomized should have baseline MELD score ≥15 and ≤20. For each subject, the study will consist of: Screening period of up to 4 weeks Randomized, double-blind treatment period of at least 48 weeks A follow-up visit 2 weeks after completion of study drug treatment The duration of each subject's participation will be at least 54 weeks for those completing the entire study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Decompensated Cirrhosis
Keywords
Cirrhosis, NASH Cirrhosis, Decompensated NASH cirrhosis, Cirrhosis, Liver, Non-Alcoholic Fatty Liver Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
210 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Emricasan (25 mg)
Arm Type
Active Comparator
Arm Description
Emricasan 25 mg
Arm Title
Emricasan (5 mg)
Arm Type
Active Comparator
Arm Description
Emricasan 5mg
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching placebo
Intervention Type
Drug
Intervention Name(s)
Emricasan (25 mg)
Other Intervention Name(s)
IDN-6556
Intervention Description
25 mg emricasan
Intervention Type
Drug
Intervention Name(s)
Emricasan (5 mg)
Other Intervention Name(s)
IDN-6556
Intervention Description
5 mg emricasan
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Matching placebo
Intervention Description
Matching Placebo
Primary Outcome Measure Information:
Title
Comparison of the effect of emricasan on improving event-free survival relative to placebo, based on a composite clinical endpoint
Time Frame
Baseline - Final Treatment Visit (at least 48 weeks to a max of 120 weeks)
Secondary Outcome Measure Information:
Title
Improvement in MELD score
Description
The effect of emricasan on improving MELD score relative to placebo
Time Frame
Baseline - Final Treatment Visit (at least 48 weeks to a max of 120 weeks)
Title
Improvement in Child-Pugh scores
Description
The effect of emricasan on improving the Child-Pugh score relative to placebo
Time Frame
Baseline - Final Treatment Visit (at least 48 weeks to a max of 120 weeks)
Title
Reduction of the proportion of subjects with MELD score progression
Description
The effect of emricasan on reducing the proportion of patients with MELD score progression (≥4 point increase at any study visit) relative to placebo
Time Frame
Baseline - Final Treatment Visit (at least 48 weeks to a max of 120 weeks)
Title
Decrease in new decompensation events
Description
The effect of emricasan on decreasing new decompensation events relative to placebo
Time Frame
Baseline - Final Treatment Visit (at least 48 weeks to a max of 120 weeks)
Title
Decrease in liver transplantation rates
Description
The effect of emricasan on decreasing liver transplantation rates (in association with MELD score ≥25) relative to placebo
Time Frame
Baseline - Final Treatment Visit (at least 48 weeks to a max of 120 weeks)
Title
Decrease in all-cause and liver specific mortality
Description
The effect of emricasan on decreasing all-cause and liver specific mortality relative to placebo
Time Frame
Baseline - Final Treatment Visit (at least 48 weeks to a max of 120 weeks)
Title
Improvement in health-related quality of life (QOL) as measured by Short Form-36
Time Frame
Baseline - Final Treatment Visit (at least 48 weeks to a max of 120 weeks)
Title
Improvement in liver metabolic function as measured by Methacetin Breath Test (MBT)
Time Frame
Baseline - Final Treatment Visit (at least 48 weeks to a max of 120 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: 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 Key Exclusion Criteria: 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 History of significant alcohol consumption within the past 5 years Current use of medications that are considered inhibitors of organic anion transporting polypeptide OATP1B1 and OATP1B3 transporters Prolongation of screening (pre-treatment) QTcF interval of >500 msecs, or history or presence of clinically concerning cardiac arrhythmias Significant systemic or major illness other than liver disease Human immunodeficiency virus infection Use of alcohol, controlled substances (including inhaled or injected drugs), or non-prescribed use of prescription drugs within 1 year of screening to the point of interfering with the subject's ability to comply with study procedures and study drug administration in the investigator's judgement
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean L Chan, MD
Organizational Affiliation
Conatus Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
The Institute for Liver Health
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
St. Joseph's Hospital & Medical Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Mayo Clinic Arizona
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Facility Name
University of Arizona Liver Research Institute
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85747
Country
United States
Facility Name
University of California, San Francisco-Fresno
City
Fresno
State/Province
California
ZIP/Postal Code
93701
Country
United States
Facility Name
Cedars Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
UCLA Pfleger Liver Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
California Liver Research Institute
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
Stanford University
City
Redwood City
State/Province
California
ZIP/Postal Code
94063
Country
United States
Facility Name
Inland Empire Liver Foundation
City
Rialto
State/Province
California
ZIP/Postal Code
92377
Country
United States
Facility Name
UC Davis GI/Hepatology Clinical Trials Unit
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Scripps Clinic - Torrey Pines
City
San Diego
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
California Pacific Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
University of Colorado Denver
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Peak Enterology Associates
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
West Haven VA Medical Center
City
West Haven
State/Province
Connecticut
ZIP/Postal Code
06516
Country
United States
Facility Name
UF Hepatology Research at CTRB
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Mayo Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Florida Research Institute
City
Lakewood Ranch
State/Province
Florida
ZIP/Postal Code
34211
Country
United States
Facility Name
Schiff Center for Liver Disease/University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Florida Hospital Transplant Institute
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
IMIC Inc.
City
Palmetto Bay
State/Province
Florida
ZIP/Postal Code
33157
Country
United States
Facility Name
Tampa General Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Piedmont Transplant Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Gastrointestinal Specialists of Georgia
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Aquiant Research
City
Albany
State/Province
Indiana
ZIP/Postal Code
47150
Country
United States
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
University of Iowa Hospitals and Clinics/ Internal Medicine
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Delta Research Partners
City
Bastrop
State/Province
Louisiana
ZIP/Postal Code
71220
Country
United States
Facility Name
Ochsner Clinic Foundation
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Mercy Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21202
Country
United States
Facility Name
Walter Reed National Military Medical Center (WRNMMC)
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20889
Country
United States
Facility Name
Digestive Disease Associates, PA
City
Catonsville
State/Province
Maryland
ZIP/Postal Code
21228
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55901
Country
United States
Facility Name
University of Mississippi Medical Center, Division of Digestive Diseases
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Kansas City Research Institute
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64131
Country
United States
Facility Name
Rutgers New Jersey Medical School
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Facility Name
Northwell Health Inc., Sandra Atlas Bass Center for Liver Diseases.
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
NYU Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Weill Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Columbia University Medical Center - Center for Liver Disease and Transplantation
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Carolinas Healthcare System, Center for Liver Disease
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Diabetes & Endocrinology Consultants, PC
City
Morehead City
State/Province
North Carolina
ZIP/Postal Code
28557
Country
United States
Facility Name
UC Health/ UCPC LLC
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Options Health Research, LLC
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
GHS Gastroenterology and Liver Center
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
ClinSearch, LLC
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Texas Clinical Research Institute
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
Facility Name
Methodist Health System Clinical Research Institute
City
Dallas
State/Province
Texas
ZIP/Postal Code
75203
Country
United States
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Baylor Scott & White Research Institute
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Baylor College of Medicine - Advanced Liver Therapies
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Liver Associates of Texas, P.A.
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
American Research Corporation at the Texas Liver Institue
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Methodist Specialty & Transplant Hospital
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
San Antonio Military Medical Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78234
Country
United States
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Emeritas Research Group LLC
City
Leesburg
State/Province
Virginia
ZIP/Postal Code
20176
Country
United States
Facility Name
Banner University Medical Center - Phoenix Transplant Institute
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23602
Country
United States
Facility Name
Bon Secours Liver Institute of Virginia
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23226
Country
United States
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Swedish Organ Transplant and Liver Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
University of Washington Harborview Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33038432
Citation
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.
Results Reference
derived

Learn more about this trial

Emricasan, a Caspase Inhibitor, for Treatment of Subjects With Decompensated NASH Cirrhosis

We'll reach out to this number within 24 hrs