Status:
TERMINATED
Post-Treatment Follow-up Study for Liver Disease Subjects With or Without Cirrhosis After Receiving Emricasan or Placebo
Lead Sponsor:
Conatus Pharmaceuticals Inc.
Conditions:
Liver Diseases
Liver Fibrosis
Eligibility:
All Genders
18+ years
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 st...
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 enr...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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).
Key Trial Info
Start Date :
February 27 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 30 2019
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03479125
Start Date
February 27 2018
End Date
September 30 2019
Last Update
November 22 2019
Active Locations (3)
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1
Inland Empire Liver Foundation
Rialto, California, United States, 92377
2
Options Health Research, LLC
Tulsa, Oklahoma, United States, 74104
3
Gastro One
Germantown, Tennessee, United States, 38138