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

Conatus Pharmaceuticals

Status: Terminated

Conditions: Orthotopic Liver Transplantation; Decompensated Non-Alcoholic Steatohepatitis Cirrhosis; NASH Fibrosis; Liver Cirrhosis; Liver Fibrosis; Liver Diseases

Treatments: Diagnostic Test: Ultrasound

Study type: Observational

Funder types: Industry

Identifiers

NCT03479125

IDN-6556-18

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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).

Trial design

40 participants in 1 patient group

Historical emricasan or placebo subjects

Description:

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.

Treatment:

Diagnostic Test: Ultrasound