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Trial record 2 of 22172 for:    Placebo AND subjects

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

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ClinicalTrials.gov Identifier: NCT03479125
Recruitment Status : Enrolling by invitation
First Posted : March 27, 2018
Last Update Posted : March 27, 2018
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment
Liver Diseases Liver Fibrosis Liver Cirrhosis NASH Fibrosis Decompensated Non-Alcoholic Steatohepatitis Cirrhosis Orthotopic Liver Transplantation Diagnostic Test: Ultrasound

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.


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Study Type : Observational
Estimated Enrollment : 832 participants
Observational Model: Case-Only
Time Perspective: Prospective
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
Actual Study Start Date : February 27, 2018
Estimated Primary Completion Date : January 31, 2022
Estimated Study Completion Date : May 31, 2022


Group/Cohort Intervention/treatment
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
Subjects will be observed to estimate the adjusted event rate for hepatocellular carcinoma with or without cirrhosis previously treated with emricasan or placebo.
Other Name: MRI. CT scan.




Primary Outcome Measures :
  1. Adjusted event rate for hepatocellular carcinoma. [ Time Frame: 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 :
  1. Adjusted event rate for all malignancies. [ Time Frame: 3 years ]
    To estimate the adjusted event rate for all malignancies in subjects with or without cirrhosis previously treated with emricasan or placebo.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03479125


Locations
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United States, California
Inland Empire Liver Foundation
Rialto, California, United States, 92377
United States, Oklahoma
Options Health Research, LLC
Tulsa, Oklahoma, United States, 74104
United States, Tennessee
Gastro One
Germantown, Tennessee, United States, 38138
Sponsors and Collaborators
Conatus Pharmaceuticals Inc.
Investigators
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Study Director: Mason Yamashita, MD Conatus Pharmaceuticals Inc.

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Responsible Party: Conatus Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT03479125     History of Changes
Other Study ID Numbers: IDN-6556-18
First Posted: March 27, 2018    Key Record Dates
Last Update Posted: March 27, 2018
Last Verified: March 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Fibrosis
Liver Cirrhosis
Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Pathologic Processes
Digestive System Diseases