Post-Treatment Follow-up Study for Liver Disease Subjects With or Without Cirrhosis After Receiving Emricasan or Placebo
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ClinicalTrials.gov Identifier: NCT03479125 |
Recruitment Status :
Terminated
(Sponsor has discontinued the development of emricasan)
First Posted : March 27, 2018
Last Update Posted : November 22, 2019
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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.
Condition or disease | Intervention/treatment |
---|---|
Liver Diseases Liver Fibrosis Liver Cirrhosis NASH Fibrosis Decompensated Non-Alcoholic Steatohepatitis Cirrhosis Orthotopic Liver Transplantation | Diagnostic Test: Ultrasound |
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.
Study Type : | Observational |
Actual Enrollment : | 40 participants |
Observational Model: | Case-Only |
Time Perspective: | Prospective |
Official Title: | Protocol IDN-6556-18 - A Post Treatment Follow-up Study for Liver Disease Subjects With or Without Liver Cirrhosis After Receiving Emricasan or Placebo |
Actual Study Start Date : | February 27, 2018 |
Actual Primary Completion Date : | August 31, 2019 |
Actual Study Completion Date : | September 30, 2019 |

Group/Cohort | Intervention/treatment |
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Historical emricasan or placebo subjects
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.
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Diagnostic Test: Ultrasound
Subjects will be observed to estimate the adjusted event rate for hepatocellular carcinoma with or without cirrhosis previously treated with emricasan or placebo.
Other Name: MRI. CT scan. |
- Adjusted event rate for hepatocellular carcinoma. [ Time Frame: 3 years ]To estimate the adjusted event rate for hepatocellular carcinoma in subjects with or without cirrhosis previously treated with emricasan or placebo.
- Adjusted event rate for all malignancies. [ Time Frame: 3 years ]To estimate the adjusted event rate for all malignancies in subjects with or without cirrhosis previously treated with emricasan or placebo.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03479125
United States, California | |
Inland Empire Liver Foundation | |
Rialto, California, United States, 92377 | |
United States, Oklahoma | |
Options Health Research, LLC | |
Tulsa, Oklahoma, United States, 74104 | |
United States, Tennessee | |
Gastro One | |
Germantown, Tennessee, United States, 38138 |
Study Director: | Mason Yamashita, MD | Conatus Pharmaceuticals Inc. |
Responsible Party: | Conatus Pharmaceuticals Inc. |
ClinicalTrials.gov Identifier: | NCT03479125 |
Other Study ID Numbers: |
IDN-6556-18 |
First Posted: | March 27, 2018 Key Record Dates |
Last Update Posted: | November 22, 2019 |
Last Verified: | November 2019 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Liver Cirrhosis Liver Diseases Fatty Liver Non-alcoholic Fatty Liver Disease |
Fibrosis Pathologic Processes Digestive System Diseases |