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

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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03479125

Enrollment

Registered

2018-03-27

Start date

2018-02-27

Completion date

2019-09-30

Last updated

2019-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief summary

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

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.

Interventions

DIAGNOSTIC_TESTUltrasound

Subjects will be observed to estimate the adjusted event rate for hepatocellular carcinoma with or without cirrhosis previously treated with emricasan or placebo.

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. 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). 2. Subjects able to provide written informed consent and able to understand and willing to comply with the requirements of the study.

Exclusion criteria

1. 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. 2. Treatment with an investigational drug following treatment with emricasan or placebo. 3. Previous transplant unless subject was enrolled from IDN-6556-07 (post orthotopic liver transplant due to HCV).

Design outcomes

Primary

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

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026