| Trial ID: | L0342 |
| Source ID: | NCT03439189
|
| Associated Drug: |
Emricasan
|
| Title: |
Companion Protocol for Methacetin Breath Test (MBT) in Conatus Protocol IDN-6556-14
|
| Acronym: |
--
|
| Status: |
Completed
|
| Study Results: |
Has Results
|
| Results: |
https://ClinicalTrials.gov/show/NCT03439189/results
|
| Conditions: |
NASH - Nonalcoholic Steatohepatitis|Cirrhosis|Portal Hypertension
|
| Interventions: |
Combination Product: Methacetin Breath Test|Drug: Emricasan|Drug: Placebo oral capsule
|
| Outcome Measures: |
Number of Subjects With Matched Clinically Significant Portal Hypertension Based on Hepatic Venous Pressure Gradient (HVPG) and Methacetin Breath Test (MBT)|Number of Matched Subjects With Significant Portal Hypertension (Defined as HVPG>=12mmHg) Based on HVPG and MBT
|
| Sponsor/Collaborators: |
Exalenz Bioscience LTD.|Conatus Pharmaceuticals
|
| Gender: |
All
|
| Age: |
18 Years and older ?? (Adult, Older Adult)
|
| Phases: |
Not applicable
|
| Enrollment: |
343
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Care Provider, Investigator)|Primary Purpose: Diagnostic
|
| Start Date: |
August 28, 2016
|
| Completion Date: |
May 13, 2019
|
| Results First Posted: |
September 4, 2020
|
| Last Update Posted: |
October 22, 2020
|
| Locations: |
Hopital Beaujon, Clichy, France
|
| URL: |
https://ClinicalTrials.gov/show/NCT03439189
|