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 : Enrolling by invitation
First Posted : March 27, 2018
Last Update Posted : March 27, 2018
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|
|Estimated Enrollment :||832 participants|
|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|
|Estimated Primary Completion Date :||January 31, 2022|
|Estimated Study Completion Date :||May 31, 2022|
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.
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.
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|
|Germantown, Tennessee, United States, 38138|
|Study Director:||Mason Yamashita, MD||Conatus Pharmaceuticals Inc.|