| Trial ID: | L0587 |
| Source ID: | EUCTR2015-004336-35-ES
|
| Associated Drug: |
Emricasan
|
| Title: |
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial
of Emricasan (IDN-6556), an Oral Caspase Inhibitor, in Subjects with Non-alcoholic Steatohepatitis (NASH) Fibrosis
|
| Acronym: |
--
|
| Status: |
Not Recruiting
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
<br>
MedDRA version: 18.1
Level: PT
Classification code 10053219
Term: Non-alcoholic steatohepatitis
System Organ Class: 10019805 - Hepatobiliary disorders
;Therap
|
| 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: |
Main Objective: To assess whether treatment with emricasan compared to matching placebo in subjects with NASH fibrosis improves fibrosis on liver biopsy by at least one stage without worsening of steatohepatitis using the NASH Clinical Research Network (CRN) Histologic Scoring System.;<br> Secondary Objective: - To assess the safety and tolerability of emricasan in subjects with NASH fibrosis, including any potential effects on metabolic parameters (insulin resistance, glycemic control, lipid levels)<br> - To assess whether emricasan compared to placebo can resolve steatohepatitis without worsening of fibrosis in subjects with NASH fibrosis<br> - To assess whether emricasan compared to placebo can improve NAFLD Activity Score (NAS), its components (steatosis, lobular inflammation, ballooning), and portal inflammation in subjects with NASH fibrosis<br> - To assess whether emricasan compared to placebo can improve collagen and fat content based on liver biopsy morphometry in subjects with NASH fibrosis<br> - To assess whether emricasan compared to placebo improves biomarkers (caspase 3/7, cCK18/M30, flCK18/M65, ALT, AST, serum fibrosis markers) in subjects with NASH fibrosis<br> - To assess whether emricasan compared to placebo improves health-related quality of life in subjects with NASH fibrosis<br> ;Timepoint(s) of evaluation of this end point: Week 72;<br> Primary end point(s): Change from baseline in fibrosis stage at 72 weeks;<br> All subjects who complete the study will have a liver biopsy at week 72. Subjects discontinuing the study early will be contacted and asked to sign a separate consent to return for a week 72 liver biopsy.<br> <br> Secondary end point(s): - Resolution of steatohepatitis (no ballooning and no more than 1 point in<br> inflammation) without worsening of fibrosis<br> - Decrease in NAS of at least 2 points without worsening of fibrosis<br> ;Timepoint(s) of evaluation of this end point: Week 72
|
| Sponsor/Collaborators: |
Conatus Pharmaceuticals Inc.
|
| Gender: |
All
|
| Age: |
nannan
|
| Phases: |
Phase 2
|
| Enrollment: |
330
|
| Study Type: |
Interventional clinical trial of medicinal product
|
| Study Designs: |
Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If con
|
| Start Date: |
18/03/2016
|
| Completion Date: |
--
|
| Results First Posted: |
--
|
| Last Update Posted: |
28 February 2019
|
| Locations: |
United States;Spain;Germany
|
| URL: |
https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-004336-35
|
