| Trial ID: | L0575 |
| Source ID: | EUCTR2015-004473-32-DE
|
| Associated Drug: |
Emricasan
|
| Title: |
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Emricasan, an Oral Caspase Inhibitor, in Subjects with Non-alcoholic Steatohepatitis (NASH) Cirrhosis and Severe Portal Hypertension
|
| Acronym: |
--
|
| Status: |
Not Recruiting
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Non-Alcoholic Steatohepatitis (NASH) Cirrhosis and Severe Portal Hypertension <br>
MedDRA version: 20.1
Level: PT
Classification code 10036200
Term: Portal hypertension
System
|
| Interventions: |
<br> Product Name: Emricasan<br> Product Code: IDN-6556<br> Pharmaceutical Form: Capsule<br> INN or Proposed INN: Emricasan<br> CAS Number: 254750-02-2<br> Current S
|
| Outcome Measures: |
<br> Main Objective: To assess whether emricasan compared to placebo leads to a mean decrease in hepatic<br> venous pressure gradient (HVPG) at Week 24 in subjects with NASH cirrhosis and severe portal hypertension.<br> ;<br> Secondary Objective: - To assess the safety and tolerability of emricasan<br> - To evaluate the dose response of emricasan on portal pressure as assessed by HVPG at week 24<br> - To assess whether emricasan compared to placebo improves HVPG response using a 20% reduction from baseline response deifinition at week 24<br> - To assess whether emricasan compared to placebo decreases mechanism specific (caspase 3/7) and non-specific (ALT) biomarkers at weeks 24 and 48<br> ;Primary end point(s): Mean Change from Baseline at Week 25 in Hepatic Venous Pressure Gradient (HVPG);Timepoint(s) of evaluation of this end point: Week 24<br> Secondary end point(s): The change from baseline at Weeks 24 and 48 in Caspase 3/7 and ALT
|
| Sponsor/Collaborators: |
--
|
| Gender: |
--
|
| Age: |
--
|
| Phases: |
Not applicable
|
| Enrollment: |
--
|
| Study Type: |
--
|
| Study Designs: |
--
|
| Start Date: |
--
|
| Completion Date: |
--
|
| Results First Posted: |
--
|
| Last Update Posted: |
--
|
| Locations: |
--
|
| URL: |
--
|
