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



Status:Enrolling by invitation
Conditions:Gastrointestinal, Gastrointestinal, Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:4/17/2018
Start Date:February 27, 2018
End Date:May 31, 2022

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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

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.

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.

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).
We found this trial at
3
sites
Tulsa, Oklahoma 74137
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Germantown, Tennessee 38138
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Germantown, TN
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Rialto, California 92377
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Rialto, CA
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