A Study to Assess Efficacy and Safety of Bezafibrate in Patients With Primary Biliary Cholangitis

Inclusion Criteria

• •PBC diagnosis (consistent with American Association for the Study of Liver Disease \[AASLD\]:
• •* History of elevated alkaline phosphatase levels.
• •* Anti-mitochondrial antibodies positivity
• •* Histopathologic evidence of nonsuppurative cholangitis and destruction of small or medium- sized bile ducts.
• •Use of ursodeoxycholic acid (UDCA) for at least 12 months at enrollment at a therapeutic dose (13 to 15 mg per Kg per day).
• •Evidence of a suboptimal biochemical response to UDCA, defined by the presence of one of the Paris II criteria.
• •Written informed consent.
• •Age ≥ 18 years.