Study to Evaluate the Efficacy and Safety of Elafibranor in Patients With Primary Biliary Cholangitis (PBC) and Inadequate Response to Ursodeoxycholic Acid

Launched by GENFIT · Apr 20, 2017

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Eligibility criteria

• Inclusion Criteria:
• • 1. Must have provided written informed consent
• 2. Definite or probable PBC diagnosis as demonstrated by the presence of at least 2 of the following 3 diagnostic factors:
• • History of elevated ALP levels for at least 6 months prior to Day 0 (randomization visit)
• • Positive Anti-Mitochondrial Antibodies (AMA) titers (\> 1/40 on immunofluorescence or M2 positive by enzyme-linked immunosorbent assay (ELISA) or positive PBC-specific antinuclear antibodies
• • Liver biopsy consistent with PBC
• • 3. ALP \>= 1.67x upper limit of normal (ULN)
• • 4. Taking UDCA for at least 12 months (stable dose for ≥ 6 months) prior to screening visit
• • 5. Contraception: Females participating in this study must be of non-childbearing potential or must be using highly efficient contraception for the full duration of the study and for 1 month after the end of treatment.
• Exclusion Criteria:
• • 1. History or presence of other concomitant liver diseases
• • 2. Screening creatine phosphokinase (CPK) \> upper limits of normal (ULN)
• • 3. Screening alanine transaminase (ALT) or aspartate aminotransferase (AST) \> 5 ULN
• • 4. Screening total bilirubin \> 2 ULN
• • 5. Screening serum creatinine \> 1.5 mg/dl
• • 6. Significant renal disease, including nephritic syndrome, chronic kidney disease (defined as patients with markers of kidney damage or estimated glomerular filtration rate \[eGFR\] of less than 60 mL/min/1.73 m\^2).
• • 7. Patients with moderate or severe hepatic impairment (defined as Child-Pugh B/C)
• • 8. Platelet count \<150 X 10\^3/microliter
• • 9. Albumin \<3.5 g/dL
• • 10. Presence of clinical complications of PBC or clinically significant hepatic decompensation
• • 11. If female: known pregnancy, or has a positive urine pregnancy test (confirmed by a positive serum pregnancy test), or lactating
• • 12. Known history of human immunodeficiency virus (HIV) infection
• • 13. Medical conditions that may cause non-hepatic increases in ALP (e.g., Paget's disease)