| Trial ID: | L0495 |
| Source ID: | JPRN-JapicCTI-184033
|
| Associated Drug: |
BMS-986036
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| 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: |
--
|
| Status: |
Recruiting
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Liver Fibrosis, Nonalcoholic Fatty Liver Disease (NAFLD), Nonalcoholic Steatohepatitis
|
| Interventions: |
Intervention name : BMS-986036<br>Dosage And administration of the intervention : Subcutaneous injection<br>Control intervention name : Placebo<br>Dosage And administration of the control intervention : Subcutaneous injection
|
| Outcome Measures: |
Proportion of participants who achieve more than 1 stage improvement in fibrosis without worsening of NASH or NASH improvement with no worsening of fibrosis as determined by liver biopsy [Time Frame: 24 weeks]<br>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)] [Time Frame: 24 weeks]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)] [Time Frame: 24 weeks]Proportion of participants with NASH CRN Fibrosis Score improvement as determined by liver biopsy [Time Frame: 24 weeks]<br>Proportion of participants with Ishak Score improvement as determined by liver biopsy [Time Frame: 24 weeks]<br>Proportion of participants with a decrease in collagen proportionate area (CPA) as determined by liver biopsy [Time Frame: 24 weeks]<br>Proportion of participants with NASH resolution without worsening of fibrosis as determined by liver biopsy [Time Frame: 24 weeks]<br>Proportion of participants with NASH resolution as determined by liver biopsy [Time Frame: 24 weeks]<br>Proportion of participants with NASH improvement without worsening of fibrosis as determined by liver biopsy [Time Frame: 24 weeks]<br>Proportion of participants with NASH improvement as determined by liver biopsy [Time Frame: 24 weeks]<br>Proportion of participants with progression to cirrhosis, as determined by liver biopsy [Time Frame: 24 weeks]<br>Incidence of adverse events (AE) [Time Frame: Up to 52 weeks]
|
| Sponsor/Collaborators: |
Bristol-Myers Squibb K.K.
|
| Gender: |
All
|
| Age: |
1875
|
| Phases: |
Phase 2
|
| Enrollment: |
160
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Randomized, Parallel Assignment, Treatment
|
| Start Date: |
04/07/2018
|
| Completion Date: |
--
|
| Results First Posted: |
--
|
| Last Update Posted: |
16 July 2019
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| Locations: |
--
|
| URL: |
https://www.clinicaltrials.jp/user/showCteDetailE.jsp?japicId=JapicCTI-184033
|
