Emricasan, a Caspase Inhibitor, for Evaluation in Subjects With Non-Alcoholic Steatohepatitis (NASH) Fibrosis
NCT ID: NCT02686762
Last Updated: 2019-08-19
Study Results
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Basic Information
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COMPLETED
PHASE2
318 participants
INTERVENTIONAL
2016-01-26
2019-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Emricasan (5 mg)
Subjects with Non-alcoholic Steatohepatitis (NASH) Fibrosis will be administered orally with emricasan (5 mg) twice a day.
Emricasan (5 mg)
Subjects with Non-alcoholic Steatohepatitis (NASH) Fibrosis will be administered orally with emricasan (5 mg) twice a day.
Emricasan (50 mg)
Subjects with Non-alcoholic Steatohepatitis (NASH) Fibrosis will be administered orally with emricasan (50 mg) twice a day.
Emricasan (50 mg)
Subjects with Non-alcoholic Steatohepatitis (NASH) Fibrosis will be administered orally with emricasan (50 mg) twice a day.
Matching Placebo
Subjects with Non-alcoholic Steatohepatitis (NASH) Fibrosis will be administered orally with a matching placebo twice a day.
Placebo
Subjects with Non-alcoholic Steatohepatitis (NASH) Fibrosis will be administered orally with a matching placebo twice a day.
Interventions
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Emricasan (5 mg)
Subjects with Non-alcoholic Steatohepatitis (NASH) Fibrosis will be administered orally with emricasan (5 mg) twice a day.
Emricasan (50 mg)
Subjects with Non-alcoholic Steatohepatitis (NASH) Fibrosis will be administered orally with emricasan (50 mg) twice a day.
Placebo
Subjects with Non-alcoholic Steatohepatitis (NASH) Fibrosis will be administered orally with a matching placebo twice a day.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Histological evidence of definite NASH based on NASH CLinical Research Network (CRN) criteria, as confirmed by the central histopathologist, on a liver biopsy obtained no more than 6 months prior to Day 1
3. NAFLD Activity Score (NAS) of 4 or greater with a score of at least 1 in each component of the NAS (steatosis scored 0-3, lobular inflammation scored 0-3, ballooning scored 0-2)
4. Fibrosis stage 1 (limited to 20% of subjects), stage 2, or stage 3 using the NASH CRN Histologic Scoring System
a. Subjects with fibrosis stage 1 must also have diabetes mellitus or metabolic syndrome
5. Willingness to utilize effective contraception (for both males and females of childbearing potential) from Screening to 4 weeks after the last dose of study drug
6. If on vitamin E or pioglitazone, subjects must have been on a stable dose for at least 3 months prior to the biopsy (whether historical or qualifying biopsy)
Exclusion Criteria
2. Use of the following drugs (which may have potential hepatotoxic effects) within 6 months prior to Day 1: amiodarone, methotrexate, tamoxifen, valproic acid, estrogens at doses greater than those used for hormone replacement or contraception, anabolic steroids, or systemic glucocorticoids for more than 4 weeks at doses greater than replacement doses
3. Uncontrolled diabetes (HbA1c ≥9%) within 60 days prior to Day 1
4. Presence of cirrhosis on liver biopsy (fibrosis stage 4 based on the central histopathologist reading)
5. Hepatitis and fibrosis more likely related to etiologies other than NASH such as:
1. alcoholic steatohepatitis
2. autoimmune hepatitis
3. hepatitis B virus (HBV) infection
4. hepatitis C virus (HCV) infection
5. primary biliary cirrhosis
6. primary sclerosing cholangitis
7. Wilson's disease
8. alpha-1-antitrypsin deficiency
9. hemochromatosis or iron overload
10. drug-induced liver disease
11. other biliary liver disease
6. ALT or AST \>5 times upper limit of normal (ULN) or total bilirubin \>1.5 times ULN during screening (unless subject has elevated total bilirubin due to Gilbert's as documented in the medical records)
7. Alpha-fetoprotein \>200 ng/mL
8. Hemoglobin \<10 g/dL
9. White blood cell count \<2.0 x 10\^3/mm3
10. Estimated creatinine clearance \<30 mL/min
11. Current use of the following medications that are considered significant inhibitors of OATP1B1 and OATP1B3 transporters: atazanavir, cyclosporine, eltrombopag, gemfibrozil, indinavir, lopinavir, ritonavir, rifampin, saquinavir, simeprevir, telaprevir, tipranovir, or some combination of these medications
12. Symptoms of biliary colic, e.g. due to symptomatic gallstones, within the last 6 months, unless resolved following cholecystectomy
13. Inability to safely obtain a liver biopsy
14. Known human immunodeficiency virus (HIV) infection
15. Weight loss ≥ 10% within 6 months of Day 1
16. Use of 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
17. History of or active malignancies, other than those successfully treated with curative intent and believed to be cured
18. Significant systemic or major illness other than liver disease that in the opinion of the investigator would preclude the subject from participating in and completing the study, including but not limited to acute coronary syndrome or stroke within 6 months of screening or major surgery within 3 months of screening
19. History or presence of clinically concerning cardiac arrhythmias, or prolongation of Screening (pre-treatment) QTcF interval \>480 milliseconds (msec)
20. Prior or planned (during the time frame of the study) bariatric surgery
21. If female: planned or known pregnancy, positive urine or serum pregnancy test, or lactating/breastfeeding
22. Previous treatment with emricasan or active investigational medication in a clinical trial within 6 months prior to Day 1
23. Prior liver transplant
18 Years
ALL
No
Sponsors
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Conatus Pharmaceuticals Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Jean L Chan, MD
Role: STUDY_CHAIR
Conatus Pharmaceuticals Inc.
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
University of Arizona Clinical and Translational Sciences Research Center
Tucson, Arizona, United States
Preferred Research Partners, Inc.
Little Rock, Arkansas, United States
Fresno Clinical Research Center
Freestone, California, United States
UCLA The Pfleger Liver Institute
Los Angeles, California, United States
Gastrointestinal Biosciences
Los Angeles, California, United States
Surinder Singh Saini, M.D., Inc.
Newport Beach, California, United States
California Liver Research Institute
Pasadena, California, United States
Inland Empire Liver Foundation
Rialto, California, United States
University of California Davis Medical Center
Sacramento, California, United States
University of California San Diego Medical Center
San Diego, California, United States
Cedars Sinai Medical Center
West Hollywood, California, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Sibley Memorial Hospital
Washington D.C., District of Columbia, United States
Howard University
Washington D.C., District of Columbia, United States
UF Hepatology Research at CTRB
Gainesville, Florida, United States
Florida Digestive Health Specialist
Lakewood Rch, Florida, United States
Miami Veterans Administration Healthcare System
Miami, Florida, United States
University of Miami/Schiff Center for Liver Diseases
Miami, Florida, United States
Florida Hospital Orlando Transplant Institute
Orlando, Florida, United States
Tampa General Medical Group
Tampa, Florida, United States
iResearch Atlanta LLC
Decatur, Georgia, United States
Gastrointestinal Specialists of Georgia
Marietta, Georgia, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
Rush University Medical Center
Chicago, Illinois, United States
The University of Chicago Medical Center
Chicago, Illinois, United States
Aquiant Research
New Albany, Indiana, United States
Iowa Digestive Disease Center, P.C
Clive, Iowa, United States
UnityPoint Clinic Center For Liver Disease
Des Moines, Iowa, United States
University of Louisville
Louisville, Kentucky, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Louisiana Research Center, LLC
Shreveport, Louisiana, United States
Mercy Medical Center
Baltimore, Maryland, United States
Walter Reed National Military Medical Center
Bethesda, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Lahey Clinic Medical Center
Burlington, Massachusetts, United States
Henry Ford Health System
Detroit, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Kansas City VA Medical Center
Kansas City, Missouri, United States
Kansas City Research Institute
Kansas City, Missouri, United States
Washington University School of Medicine-Infectious Disease Clinical Research Unit
St Louis, Missouri, United States
Doctors Office Center
Newark, New Jersey, United States
State University of New York
Buffalo, New York, United States
Northwell Health, Inc.
Manhasset, New York, United States
Mount Sinai Beth Israel Medical Center
New York, New York, United States
NYU Langone Medical Center
New York, New York, United States
Columbia University Medical Center (CUMC)
New York, New York, United States
Weill Cornell Medical College
New York, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Asheville Gastroenterology Associates, PA
Asheville, North Carolina, United States
Carolinas Healthcare System, Center for Liver Disease
Charlotte, North Carolina, United States
Duke University Medical Center, Duke South Clinics
Durham, North Carolina, United States
Rex Healthcare
Raleigh, North Carolina, United States
Consultants for Clinical Research
Cincinnati, Ohio, United States
University Hospitals Case Medical Center
Cleveland, Ohio, United States
Options Health Research, LLC
Tulsa, Oklahoma, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
Albert Einstein Medical Center
Philadelphia, Pennsylvania, United States
University Gastroenterology
Providence, Rhode Island, United States
Medical University of South Carolina
Charleston, South Carolina, United States
PMG Research at Charleston
Charleston, South Carolina, United States
ClinSearch, LLC
Chattanooga, Tennessee, United States
Gastro One
Germantown, Tennessee, United States
Methodist University Hospital
Memphis, Tennessee, United States
Vanderbilt University Medical Center - Digestive Disease Center
Nashville, Tennessee, United States
Texas Clinical Research Institute
Arlington, Texas, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Baylor All Saints Medical Center
Fort Worth, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Liver Associates of Texas, P.A.
Houston, Texas, United States
Research Specialists of Texas
Houston, Texas, United States
Pinnacle Clinical Research, PLLC
Live Oak, Texas, United States
American Research Corporation at the Texas Liver Institue
San Antonio, Texas, United States
Brooke Army Medical Center
San Antonio, Texas, United States
University of Utah Health Sciences Center
Salt Lake City, Utah, United States
University of Vermont
Burlington, Vermont, United States
Bon Secours Richmond Health System
Newport News, Virginia, United States
Digestive and Liver Disease Specialists
Norfolk, Virginia, United States
McGuire VA Medical Center
Richmond, Virginia, United States
University of Washington Harborview Medical Center
Seattle, Washington, United States
Universitätsklinikum der RWTH Aachen
Aachen, North Rhine-Westphalia, Germany
Universitätsklinikum Bonn
Bönning, North Rhine-Westphalia, Germany
Universitätsklinikum Münster
Münster, North Rhine-Westphalia, Germany
Charité - Universitätsmedizin Berlin
Berlin, , Germany
Universitätsklinikum Freiburg
Freiburg im Breisgau, , Germany
Universitätsklinikum Hamburg Eppendorf
Hamburg, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
Eugastro GmbH
Leipzig, , Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, , Germany
Hospital Universitario Vall d'Hebron
Barcelona, , Spain
Hospital Clinic de Barcelona
Barcelona, , Spain
Hospital Universitario de Donostia
Donostia / San Sebastian, , Spain
Hospital Universitario de La Princesa
Madrid, , Spain
Hospital General Universitario Gregorio Marañon
Madrid, , Spain
Hospital Universitario Ramon y Cajal
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Universitario Puerta de Hierro - Majadahonda
Majadahonda, , Spain
Hospital Universitario Marques de Valdecilla
Santander, , Spain
Hospital Clinico Universitario de Valencia
Valencia, , Spain
Hospital General Universitario de Valencia
Valencia, , Spain
Countries
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References
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Harrison SA, Goodman Z, Jabbar A, Vemulapalli R, Younes ZH, Freilich B, Sheikh MY, Schattenberg JM, Kayali Z, Zivony A, Sheikh A, Garcia-Samaniego J, Satapathy SK, Therapondos G, Mena E, Schuppan D, Robinson J, Chan JL, Hagerty DT, Sanyal AJ. A randomized, placebo-controlled trial of emricasan in patients with NASH and F1-F3 fibrosis. J Hepatol. 2020 May;72(5):816-827. doi: 10.1016/j.jhep.2019.11.024. Epub 2019 Dec 27.
Other Identifiers
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IDN-6556-12
Identifier Type: -
Identifier Source: org_study_id
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