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Summary

for people ages 18 years and up (full criteria)
at Freestone, California and other locations
study started
estimated completion:

Description

Summary

This is a multicenter, double-blind, randomized, placebo-controlled trial involving subjects with a diagnosis of "definite NASH" with fibrosis (excluding cirrhosis) as determined by the central histopathologist. Upon successful screening, subjects will be randomized to receive either emricasan 50 mg BID or emricasan 5 mg BID or matching placebo BID.

Official Title

A Multicenter, Randomized, Double-Blind, Placebo-controlled Trial of Emricasan (IDN-6556-12), an Oral Caspase Inhibitor, in Subjects With Non-alcoholic Steatohepatitis (NASH) Fibrosis

Keywords

Non-alcoholic Steatohepatitis Fibrosis Liver Diseases NASH Caspase Inhibitors

Eligibility

You can join if…

Open to people ages 18 years and up

  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. 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
  5. Subjects with fibrosis stage 1 must also have diabetes mellitus or metabolic syndrome
  6. 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
  7. 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)

You CAN'T join if...

  1. Current or history of significant alcohol consumption, defined as more than 20 g/day for females and more than 30 g/day in males on average, or inability to reliably quantify alcohol consumption based on investigator's judgement
  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:
  6. alcoholic steatohepatitis
  7. autoimmune hepatitis
  8. hepatitis B virus (HBV) infection
  9. hepatitis C virus (HCV) infection
  10. primary biliary cirrhosis
  11. primary sclerosing cholangitis
  12. Wilson's disease
  13. alpha-1-antitrypsin deficiency
  14. hemochromatosis or iron overload
  15. . drug-induced liver disease
  16. . other biliary liver disease
  17. 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)
  18. Alpha-fetoprotein >200 ng/mL
  19. Hemoglobin <10 g/dL
  20. White blood cell count <2.0 x 103/mm3

  21. . Estimated creatinine clearance <30 mL/min
  22. . 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

  1. . Symptoms of biliary colic, e.g. due to symptomatic gallstones, within the last 6 months, unless resolved following cholecystectomy
  2. . Inability to safely obtain a liver biopsy
  3. . Known human immunodeficiency virus (HIV) infection
  4. . Weight loss ≥ 10% within 6 months of Day 1
  5. . 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
  6. . History of or active malignancies, other than those successfully treated with curative intent and believed to be cured
  7. . 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
  8. . History or presence of clinically concerning cardiac arrhythmias, or prolongation of Screening (pre-treatment) QTcF interval >480 milliseconds (msec)
  9. . Prior or planned (during the time frame of the study) bariatric surgery
  10. . If female: planned or known pregnancy, positive urine or serum pregnancy test, or lactating/breastfeeding
  11. . Previous treatment with emricasan or active investigational medication in a clinical trial within 6 months prior to Day 1
  12. . Prior liver transplant

Locations

  • Fresno Clinical Research Center
    Freestone, California, 93701, United States
  • University of California Davis Medical Center
    Sacramento, California, 95817, United States
  • UCLA The Pfleger Liver Institute
    Los Angeles, California, 90024, United States
  • Cedars Sinai Medical Center
    West Hollywood, California, 90048, United States
  • Gastrointestinal Biosciences
    Los Angeles, California, 90067, United States
  • California Liver Research Institute
    Pasadena, California, 91105, United States
  • Inland Empire Liver Foundation
    Rialto, California, 92377, United States
  • Surinder Singh Saini, M.D., Inc.
    Newport Beach, California, 92660, United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Conatus Pharmaceuticals Inc.
ID
NCT02686762
Phase
Phase 2
Lead Scientist
Bilal Hameed
Study Type
Interventional
Last Updated
August 1, 2017