| Trial ID: | L0817 |
| Source ID: | NCT03205345
|
| Associated Drug: |
Emricasan
|
| Title: |
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Emricasan, an Oral Caspase Inhibitor, in Subjects With Decompensated Non-Alcoholic Steatohepatitis (NASH) Cirrhosis
|
| Acronym: |
ENCORE-LF
|
| Status: |
Not recruiting
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Decompensated Cirrhosis
|
| Interventions: |
Drug: Emricasan (25 mg);Drug: Emricasan (5 mg);Drug: Placebo
|
| Outcome Measures: |
Comparison of the effect of emricasan on improving event-free survival relative to placebo, based on a composite clinical endpointImprovement in MELD score;Improvement in Child-Pugh scores;Reduction of the proportion of subjects with MELD score progression;Decrease in new decompensation events;Decrease in liver transplantation rates;Decrease in all-cause and liver specific mortality;Improvement in health-related quality of life (QOL) as measured by Short Form-36;Improvement in liver metabolic function as measured by Methacetin Breath Test (MBT)
|
| Sponsor/Collaborators: |
Conatus Pharmaceuticals Inc.
|
| Gender: |
All
|
| Age: |
18 Yearsnan
|
| Phases: |
Phase 2
|
| Enrollment: |
210
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).
|
| Start Date: |
20/06/2017
|
| Completion Date: |
--
|
| Results First Posted: |
--
|
| Last Update Posted: |
12 December 2020
|
| Locations: |
United States
|
| URL: |
https://clinicaltrials.gov/show/NCT03205345
|
