Duke logo

Conatus 17- Decompensated Non-Alcoholic Steatohepatitis (NASH) Cirrhosis - Clinical Trial

What is the Purpose of this Study?

We are doing this study to learn if a study drug called Emricasan reduces your risk of complications related to your liver disease

What is the Condition Being Studied?

Decompensated (complications) cirrhosis due to NASH

Who Can Participate in the Study?

Adult men and women with:
- Decompensated cirrhosis due to NASH -
- A history of a gastrointestinal bleed
- Risk factors for NASH such as diabetes or obesity

Age Group
Adults

What is Involved?

If you agree to join the study, you will:
- Be in the study for at least 56 weeks, including up to 6 weeks for screening, 48 weeks of study drug regimen, and 2 weeks of follow-up
- Be randomized (like drawing numbers from a hat) to get the study drug (Emricasan) or placebo:
--- Emricasan 5mg
--- Emricasan 25mg
--- Placebo (a sugar pill)
(Neither you nor the study team will know whether you are getting Emricasan or placebo but they can find out in an emergency)

- Have several tests and procedures including, physical exam, blood and urine samples taken, electrocardiogram (EKG), a tracing of the electrical activity of the heart, liver CT or MRI Scan, ultrasound of your liver and gallbladder
- Have a breath test to measure your liver function
- Answer screening questionnaires for alcohol dependence

Study Details

Full Title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Emricasan, an Oral Caspase Inhibitor, in Subjects with Decompensated Non-Alcoholic Steatohepatitis (NASH) Cirrhosis
Principal Investigator
Protocol Number
IRB:PRO00084812
NCT:NCT03205345
Phase
Phase II
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698