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

NCT03479125 | Terminated DMC FDA Drug

• 1 other identifier: IDN-6556-18
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 3

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Adjusted event rate for hepatocellular carcinoma.

  To estimate the adjusted event rate for hepatocellular carcinoma in subjects with or without cirrhosis previously treated with emricasan or placebo.

  3 years

Secondary Outcomes (1)

• Adjusted event rate for all malignancies.

  3 years

Study Arms (1)

Historical emricasan or placebo subjects

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.

Diagnostic Test: Ultrasound

Interventions

Ultrasound DIAGNOSTIC_TEST

Subjects will be observed to estimate the adjusted event rate for hepatocellular carcinoma with or without cirrhosis previously treated with emricasan or placebo.

Also known as: MRI. CT scan.

Historical emricasan or placebo subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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).
• Subjects able to provide written informed consent and able to understand and willing to comply with the requirements of the study.

You may not qualify if:

• 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.
• Treatment with an investigational drug following treatment with emricasan or placebo.
• Previous transplant unless subject was enrolled from IDN-6556-07 (post orthotopic liver transplant due to HCV).

Sponsors & Collaborators

• Conatus Pharmaceuticals Inc.: lead

Study Sites (3)

Inland Empire Liver Foundation

Rialto, California, 92377, United States

Location

Options Health Research, LLC

Tulsa, Oklahoma, 74104, United States

Location

Gastro One

Germantown, Tennessee, 38138, United States

Location

MeSH Terms

Conditions

Liver Diseases; Liver Cirrhosis

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Mason Yamashita, MD

  Conatus Pharmaceuticals Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2018
• First Posted: March 27, 2018
• Study Start: February 27, 2018
• Primary Completion: August 31, 2019
• Study Completion: September 30, 2019
• Last Updated: November 22, 2019

Record last verified: 2019-11

Locations

US (3)