| Trial ID: | L0494 |
| Source ID: | JPRN-JapicCTI-184032
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| 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 Compensated Liver Cirrhosis
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| Acronym: |
--
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| Status: |
Not Recruiting
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| Study Results: |
No Results Available
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| Results: |
--
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| Conditions: |
Hepatic Cirrhosis, Liver Fibrosis, Nonalcoholic Fatty Liver Disease (NAFLD), Nonalcoholic Steatohepatitis
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| Interventions: |
Intervention name : BMS-986036<br>INN of the intervention : Pegbelfermin<br>Dosage And administration of the intervention : Subcutaneous injection<br>Control intervention name : Placebo<br>INN of the control intervention : -<br>Dosage And administration o
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| Outcome Measures: |
efficacy<br>Proportion of participants who achieve more than 1 stage improvement in fibrosis without worsening of NASH as determined by liver biopsy [Time Frame: 48 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: 48 weeks]<br>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: 48 weeks]safety, efficacy, exploratory, pharmacokinetics, pharmacodynamics, pharmacogenomics<br>Proportion of participants with Ishak Score improvement as determined by liver biopsy [ Time Frame: 48 weeks ]<br>Proportion of participants with a more than 1 stage improvement in fibrosis without worsening of NASH or NASH improvement as determined by liver biopsy [ Time Frame: 48 weeks ]<br>Proportion of participants with a decrease in collagen propionate area (CPA) as determined by liver biopsy [ Time Frame: 48 weeks ]<br>Proportion of participants with NASH resolution as determined by liver biopsy [ Time Frame: 48 weeks ]<br>Proportion of participants with NASH improvement as determined by liver biopsy [ Time Frame: 48 weeks ]<br>Number of adverse events (AE) [ Time Frame: Up to 52 weeks ]
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| Sponsor/Collaborators: |
Bristol-Myers Squibb K.K.
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| Gender: |
All
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| Age: |
1875
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| Phases: |
Phase 2
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| Enrollment: |
100
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| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Randomized, Parallel Assignment, Treatment
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| Start Date: |
04/07/2018
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| Completion Date: |
--
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| Results First Posted: |
--
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| Last Update Posted: |
15 June 2020
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| Locations: |
Japan, North America
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| URL: |
https://www.clinicaltrials.jp/user/showCteDetailE.jsp?japicId=JapicCTI-184032
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