Post-Treatment Follow-up Study for Liver Disease Subjects With or Without Cirrhosis After Receiving Emricasan or Placebo

Study Overview
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Brief Summary
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A post-treatment follow-up observational study for liver disease subjects with or without liver cirrhosis after receiving emricasan or placebo. Subjects must have been enrolled in a prior IDN-6556 study to be eligible.

Detailed Description
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A multi-center, post-treatment follow-up observational study for liver disease subjects with or without liver cirrhosis after receiving emricasan or placebo. This phase 2 observational study will enroll subjects from Study IDN-6556-07 (Post Orthotropic Liver Transplantation - NCT02138253), IDN-6556-12 (NASH Fibrosis - NCT02686762), IDN-6556-14 (NASH Cirrhosis and Severe Portal Hypertension - NCT02960204) or IDN-6556-17 (Decompensated NASH Cirrhosis - NCT03205345) who have received at least one dose of emricasan or placebo.

Official Title
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Protocol IDN-6556-18 - A Post Treatment Follow-up Study for Liver Disease Subjects With or Without Liver Cirrhosis After Receiving Emricasan or Placebo

Conditions
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Liver Diseases, Liver Fibrosis, Liver Cirrhosis, NASH Fibrosis, Decompensated Non-Alcoholic Steatohepatitis Cirrhosis, Orthotopic Liver Transplantation

Intervention / Treatment
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* Diagnostic Test: Ultrasound


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects previously treated with at least 1 dose of emricasan or placebo from clinical studies IDN-6556-07 (post orthotopic liver transplant due to HCV), IDN-6556-12 (NASH fibrosis), IDN-6556-14 (NASH cirrhosis), or IDN-6556-17 (NASH cirrhosis). Subjects able to provide written informed consent and able to understand and willing to comply with the requirements of the study. Exclusion Criteria: 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, in the investigator's judgement, with study procedures. Treatment with an investigational drug following treatment with emricasan or placebo. Previous transplant unless subject was enrolled from IDN-6556-07 (post orthotopic liver transplant due to HCV).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Historical emricasan or placebo subjects<br>Subjects with liver fibrosis or cirrhosis who have received at least one dose of emricasan or placebo in a prior IDN-6556 study including IDN-6556-07, IDN-6556-12, IDN-6556-14 or IDN-6556-17. | Diagnostic Test: Ultrasound<br>* Subjects will be observed to estimate the adjusted event rate for hepatocellular carcinoma with or without cirrhosis previously treated with emricasan or placebo.<br>* Other names: MRI. CT scan.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adjusted event rate for hepatocellular carcinoma. | To estimate the adjusted event rate for hepatocellular carcinoma in subjects with or without cirrhosis previously treated with emricasan or placebo. | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adjusted event rate for all malignancies. | To estimate the adjusted event rate for all malignancies in subjects with or without cirrhosis previously treated with emricasan or placebo. | 3 years |