Post-Treatment Follow-up Study for Liver Disease Subjects With or Without Cirrhosis After Receiving Emricasan or Placebo
Stopped early · Has a placebo group
Conditions studied: Liver Diseases, Liver Fibrosis, Liver Cirrhosis, NASH Fibrosis, Decompensated Non-Alcoholic Steatohepatitis Cirrhosis, Orthotopic Liver Transplantation
In brief
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.
Key facts
- Study ID
- NCT03479125
- Run by
- Conatus Pharmaceuticals Inc.
- People needed
- 40
- Starts
- 2018-02-27
- Expected to finish
- 2019-09-30
- Last updated by the study team
- 2019-11-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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).
Where it is running
- Inland Empire Liver Foundation — Rialto, California, United States
- Options Health Research, LLC — Tulsa, Oklahoma, United States
- Gastro One — Germantown, Tennessee, United States
Full record on ClinicalTrials.gov
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