| Trial ID: | L0773 |
| Source ID: | CTRI/2019/01/017014
|
| Associated Drug: |
Tropifexor
|
| Title: |
A Randomized, Double-blind, Multicenter Study to Assess the Safety, Tolerability, and Efficacy of a Combination Treatment of Tropifexor (LJN452) and Cenicriviroc (CVC) in Adult Patients With Nonalcoholic Steatohepatitis (NASH) and Liver Fibrosis
|
| Acronym: |
--
|
| Status: |
Recruiting
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Health Condition 1: K70-K77- Diseases of liver
|
| Interventions: |
Intervention1: ARM A_Tropifexor (LJN452): dose-140 ????g, frequency- once daily, route of administration-oral , hard gelatin capsules, total duration- 48 weeks<br>Intervention2: ARM C_Tropifexor (LJN452)& Cenicriviroc (CVC): Dose- Tropifexor 140 ????g & C
|
| Outcome Measures: |
Number of participants with Adverse Events <br/ ><br>Occurrence of adverse events and serious adverse eventsTimepoint: 48 Weeks?????Proportion of participants who have at least a one point improvement in fibrosisTimepoint: baseline to 48 Weeks;?????Proportion of participants with resolution of steatohepatitisTimepoint: baseline to 48 weeks
|
| Sponsor/Collaborators: |
Novartis Healthcare Private Limited
|
| Gender: |
--
|
| Age: |
nannan
|
| Phases: |
Phase 2
|
| Enrollment: |
200
|
| Study Type: |
Interventional
|
| Study Designs: |
Other<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Participant and Investigator Blinded
|
| Start Date: |
09/01/2019
|
| Completion Date: |
--
|
| Results First Posted: |
--
|
| Last Update Posted: |
24 November 2021
|
| Locations: |
Belgium;Canada;Czech Republic;Egypt;Estonia;France;Germany;Hong Kong;India;Israel;Italy;Latvia;Portugal;Russian Federation;Singapore;Spain;Switzerland;Turkey;United Kingdom;United States of America;Argentina
|
| URL: |
http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=28084
|
