Non-alcoholic steatohepatitis (NASH)
Conditions
Brief summary
Resolution of NASH and improvement of fibrosis at Week 72, defined by NASH CRN scores for ballooning of 0 and inflammation of 0 to 1, and fibrosis score ≥1 stage decrease compared to Baseline.
Detailed description
Resolution of NASH and no worsening of fibrosis at Week 72, defined by NASH CRN scores for ballooning of 0, inflammation of 0 to 1, and no increase in fibrosis score when compared to Baseline; Improvement of fibrosis and no worsening of NASH at Week 72, defined by a decrease in NASH CRN fibrosis score ≥1 stage from Baseline and no increase in scores for ballooning, inflammation, or steatosis
Interventions
DRUGPL1
DRUGLanifibranor
DRUGmicrocrystalline cellulose
DRUGpre gelatinized starch
DRUGmagnesium stearate
DRUGopadry™ II 85F18422
DRUGpurified water
Sponsors
Inventiva
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Resolution of NASH and improvement of fibrosis at Week 72, defined by NASH CRN scores for ballooning of 0 and inflammation of 0 to 1, and fibrosis score ≥1 stage decrease compared to Baseline. | — |
Secondary
| Measure | Time frame |
|---|---|
| Resolution of NASH and no worsening of fibrosis at Week 72, defined by NASH CRN scores for ballooning of 0, inflammation of 0 to 1, and no increase in fibrosis score when compared to Baseline; Improvement of fibrosis and no worsening of NASH at Week 72, defined by a decrease in NASH CRN fibrosis score ≥1 stage from Baseline and no increase in scores for ballooning, inflammation, or steatosis | — |
Countries
Belgium, Bulgaria, Czechia, France, Germany, Hungary, Italy, Netherlands, Poland, Portugal, Spain
Outcome results
None listed