Loading clinical trials...

Post-Treatment Follow-up Study for Liver Disease Subjects With or Without Cirrhosis After Receiving Emricasan or Placebo | Clinical Trials | Clareo Health

TERMINATED

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

NCT03479125•Conatus Pharmaceuticals Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

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).

Locations (3)

Inland Empire Liver Foundation

Rialto, California, United States

Options Health Research, LLC

Tulsa, Oklahoma, United States

Gastro One

Germantown, Tennessee, United States

Key Dates

Start Date

February 27, 2018

Primary Completion Date

August 31, 2019

Completion Date

September 30, 2019

Last Updated

November 22, 2019

Enrollment

ACTUAL participants

Conditions

Liver DiseasesLiver FibrosisLiver CirrhosisNASH FibrosisDecompensated Non-Alcoholic Steatohepatitis CirrhosisOrthotopic Liver Transplantation

Interventions

Ultrasound

DIAGNOSTIC_TEST

Rapid Breath-hold Quantitative Macromolecular Proton Fraction Imaging for Liver Fibrosis

NCT04429100

Liver Fibrosis

View study

RECRUITINGPHASE3

LIVERAGE™: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Moderate or Advanced Liver Fibrosis

NCT06632444

Metabolic Dysfunction Associated Steatohepatitis (MASH)Liver Fibrosis

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 22, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Rapid Breath-hold Quantitative Macromolecular Proton Fraction Imaging for Liver Fibrosis

LIVERAGE™: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Moderate or Advanced Liver Fibrosis

MAsS Scan as a Predictor of Morbidity and Mortality in Patients With Liver Disease

Verification of Risk Factors of Thrombohemorrhagic Complications in Recipients After Related Liver Transplantation

Analysis of Methylomic Features and Prognostic Risk Prediction in Patients With Hepatitis B-related Acute-on-chronic Liver Failure

Alcohol Misuse Treatment to Patients Newly Diagnosed With Alcohol-related Liver Disease: a Randomized Controlled Trial