Clinical trial NCT03479125: Post-Treatment Follow-up Study for Liver Disease Subjects With or Without Cirrhosis After Receiving Emricasan or Placebo
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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Liver Diseases
Liver Fibrosis
Liver Cirrhosis
NASH Fibrosis
Decompensated Non-Alcoholic Steatohepatitis Cirrhosis
Orthotopic Liver Transplantation
Lead sponsor: Conatus Pharmaceuticals Inc.
Sponsor class: INDUSTRY
First posted: 2018-03-27
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who previously received at least one dose of emricasan or placebo in clinical study IDN-6556-07 (post orthotopic liver transplant due to HCV), IDN-6556-12 (NASH fibrosis), IDN-6556-14 (NASH cirrhosis), and IDN-6556-17 (NASH cirrhosis).

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Adjusted event rate for hepatocellular carcinoma.
timeFrame: 3 years
Secondary outcomes:
measure: Adjusted event rate for all malignancies.
timeFrame: 3 years
Other outcomes:
Locations:
city: Rialto
country: United States
facility: Inland Empire Liver Foundation
state: California
city: Tulsa
country: United States
facility: Options Health Research, LLC
state: Oklahoma
city: Germantown
country: United States
facility: Gastro One
state: Tennessee
Study officials:
affiliation: Conatus Pharmaceuticals Inc.
name: Mason Yamashita, MD
role: STUDY_DIRECTOR
References: