| Trial ID: | L0505 |
| Source ID: | NCT03486899
|
| 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 Stage 3 Liver Fibrosis
|
| Acronym: |
FALCON 1
|
| Status: |
Not recruiting
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
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 or NASH improvement with no worsening of fibrosis as determined by liver biopsy;NASH Clinical Research Network (CRN) Fibrosis Score [Fibrosis measured on a 0-4 scale: 0 (none); 1 (perisinusoidal or periportal); 2 (perisinusoidal and portal/periportal); 3 (bridging fibrosis); 4 (cirrhosis)];NAFLD Activity Score (NAS) [NASH disease activity in the liver measured on a 0-8 scale: unweighted sum of steatosis, or fat (scale: 0-3), lobular inflammation (scale: 0-3), and hepatocellular ballooning (scale: 0-2)]Proportion of participants with NASH CRN Fibrosis Score improvement as determined by liver biopsy;Proportion of participants with Ishak Score improvement as determined by liver biopsy;Proportion of participants with a decrease in collagen proportionate area (CPA) as determined by liver biopsy;Proportion of participants with NASH resolution without worsening of fibrosis as determined by liver biopsy;Proportion of participants with NASH resolution as determined by liver biopsy;Proportion of participants with NASH improvement without worsening of fibrosis as determined by liver biopsy;Proportion of participants with NASH improvement as determined by liver biopsy;Proportion of participants with progression to cirrhosis, as determined by liver biopsy;Incidence of adverse events (AE)
|
| Sponsor/Collaborators: |
Bristol-Myers Squibb
|
| Gender: |
All
|
| Age: |
18 Years75 Years
|
| Phases: |
Phase 2
|
| Enrollment: |
160
|
| 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: |
21 July 2021
|
| Locations: |
United States;Japan;United States;Canada
|
| URL: |
https://clinicaltrials.gov/show/NCT03486899
|
