NCT03479125

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

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 40 (actual)
• Sponsor: Conatus Pharmaceuticals Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Liver Diseases
• Liver Fibrosis
• Liver Cirrhosis
• NASH Fibrosis
• Decompensated Non-Alcoholic Steatohepatitis Cirrhosis
• Orthotopic Liver Transplantation

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-02-27
• Primary completion: 2019-08-31
• Completion: 2019-09-30
• First posted: 2018-03-27
• Last updated: 2019-11-22

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study