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

Overview

About this study

The purpose of this multicenter, double-blind, randomized, placebo-controlled study is 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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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

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.
  • Known human immunodeficiency virus (HIV) 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.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Hugo Vargas, M.D.

Closed for enrollment

Jacksonville, Fla.

Mayo Clinic principal investigator

Andrew Keaveny, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20358839

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