A Study to Evaluate the Efficacy and Safety of GFT505 Once Daily on Steatohepatitis in Patients With Non-Alcoholic Steatohepatitis (NASH). A Multicentre, Randomized, Double Blind, Placebo-Controlled Study, With an Adaptive Design to Allow for Initial GFT505 80mg Dosing Versus Placebo, Followed by a Second Phase Including GFT505 120mg Dose, After Review of 6-month Safety Analysis of the 80mg Data on at Least 50% of Patients.
The study duration per patient will be 80 weeks. A screening period (from 4 to 16 weeks)
will precede a 52-week double-blind treatment period and a 3 months follow-up period.
The study will be conducted in 270 patients (90 patients in the placebo arm, 90 patients in
the GFT505 80mg arm, and 90 patients in the GFT505 120mg arm).
Enrollment will be performed in two phases: during the first phase, the patients will
receive either GFT505 at a dose of 80 mg either the placebo. An independent expert committee
will review the safety data when 45 patients receiving the dose at 80 mg will have been
treated for 6 months. The committee approval will be necessary to start the second phase,
while the patients will receive either GFT505 at a dose of 80 mg, or GFT505 at a dose of 120
mg or the placebo.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Percentage of responders defined by the disappearance of steatohepatitis without worsening of fibrosis
To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the percentage of responders from baseline to Week 52, defined by the disappearance of steatohepatitis (i.e. patients no longer meeting the criteria for steatohepatitis) without worsening of fibrosis. Worsening of fibrosis is evaluated using NASH CRN (Clinical Research Network) fibrosis staging system and defined as: Progression to stage 3 or 4 for patients at stage 0, 1 or 2 on diagnostic liver biopsy Progression to stage 4 for patients at stage 3 on diagnostic liver biopsy
Rémy HANF, PhD
Development Director Genfit, France
United States: Food and Drug Administration
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