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1 Study Matches

A Double-blind, Randomized, Placebo-Controlled Study and Open-label Long Term Extension to Evaluate the Efficacy and Safety of Elafibranor 80 mg in Patients with Primary Biliary Cholangitis with Inadequate Response or Intolerance to Ursodeoxycholic Acid

This is a phase 3 double-blind (DB), randomized, placebo-controlled study with an open-label long term extension (LTE) evaluating the efficacy and safety of Elafibranor 80 mg once daily versus placebo in patients with PBC and inadequate response or intolerance to ursodeoxycholic acid (UDCA). In the DB period, patients will be randomized in a 2:1 ratio to receive Elafibranor 80 mg or placebo, once daily. The DB period will last until the last completed week 52 (V6) or until a maximum of 104 weeks DB period, whichever happens first, to further collect safety and clinical outcomes data in a DB manner. After the DB period, all patients will receive Elafibranor 80 mg daily for up to 5 years during the LTE period.
18 year(s) or older
This study is NOT accepting healthy volunteers
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Inclusion Criteria:
Males or females age of 18 to 75 years inclusive at first Screening Visit (SV)
Definite or probable PBC diagnosis
on UDCA for at least 12 months prior to screening or have history of being unable to tolerate UDCA
Exclusion Criteria:
History or presence of other concomitant liver disease
Clinically significant hepatic decompensation
Other clinically significant medical conditions that are not well controlled or for which medication needs are anticipated to change during the study
Digestive Systems & Liver Disease
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Hershey, PA