| Trial ID: | L0504 |
| Source ID: | NCT03486912
|
| Associated Drug: |
BMS-986036
|
| Title: |
A Phase 2B Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of BMS-986036 (PEG-FGF21) in Adults With Nonalcoholic Steatohepatitis (NASH) and Compensated Liver Cirrhosis
|
| Acronym: |
FALCON 2
|
| Status: |
Not recruiting
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Hepatic Cirrhosis;Liver Fibrosis;Nonalcoholic Fatty Liver Disease (NAFLD);Nonalcoholic Steatohepatitis
|
| Interventions: |
Drug: BMS-986036;Other: Placebo
|
| Outcome Measures: |
Proportion of participants who achieve =1 stage improvement in fibrosis without worsening of NASH as determined by liver biopsyProportion of participants with Ishak Score improvement as determined by liver biopsy;Proportion of participants with = 1 stage improvement in fibrosis without worsening of NASH or NASH improvement as determined by liver biopsy;Proportion of participants who achieve a = 1-stage improvement in fibrosis as determined by liver biopsy;Proportion of participants with a decrease in collagen propionate area (CPA) as determined by liver biopsy;Proportion of participants with NASH resolution as determined by liver biopsy;Proportion of participants with NASH improvement as determined by liver biopsy
|
| Sponsor/Collaborators: |
Bristol-Myers Squibb
|
| Gender: |
All
|
| Age: |
18 Years75 Years
|
| Phases: |
Phase 2
|
| Enrollment: |
155
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
|
| Start Date: |
30/03/2018
|
| Completion Date: |
--
|
| Results First Posted: |
--
|
| Last Update Posted: |
24 August 2021
|
| Locations: |
United States;Japan;United States;Canada
|
| URL: |
https://clinicaltrials.gov/show/NCT03486912
|
