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

Terminated

• Conditions: Liver Diseases; Decompensated Non-Alcoholic Steatohepatitis Cirrhosis; NASH Fibrosis; Orthotopic Liver Transplantation; Liver Fibrosis; Liver Cirrhosis
• Interventions: Diagnostic Test: Ultrasound

• Registration Number: NCT03479125
• Lead Sponsor: Conatus Pharmaceuticals Inc.

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.

Study Timeline

• Study Start: 2018-02-27
• Study First Submitted: 2018-03-20
• Study First Submitted QC: 2018-03-20
• Study First Posted: 2018-03-27
• Primary Completion: 2019-08-31
• Study Completion: 2019-09-30
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-20
• Last Update Posted: 2019-11-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 40

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Historical emricasan or placebo subjects	Ultrasound	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (3)

Gastro One; 🇺🇸 Germantown, Tennessee, United States

Inland Empire Liver Foundation; 🇺🇸 Rialto, California, United States

Options Health Research, LLC; 🇺🇸 Tulsa, Oklahoma, United States