Ensayos clínicos

Inclusion Criteria

• Must have given written informed consent (signed and dated) and any authorizations required by local law
• 18 to 75 years old (inclusive)
• Male or female 
• Has a diagnosis of primary biliary cirrhosis, by at least two of the following criteria
  • History of AP above upper limits of normal for at least six months
  • 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
  • Documented liver biopsy result consistent with PBC
• On a stable and recommended dose of ursodeoxycholic acid for the past twelve months
• AP ≥ 1.67 × ULN
• Females of reproductive potential must use at least one barrier contraceptive and a second effective birth control method during the study and for at least two weeks after the last dose
• Male subjects must use appropriate contraception (e.g., condoms) so their female partners of reproductive potential do not become pregnant during the study and for at least two weeks after the last dose

Exclusion Criteria

• A medical condition, other than PBC, that in the investigator's opinion would preclude full participation in the study or confound its results (e.g., cancer on active treatment)
• AST or ALT > 3 × ULN
• Total bilirubin > 2 × ULN
• Auto-immune hepatitis
• Primary sclerosing cholangitis
• Known history of alpha-1-Antitrypsin deficiency
• Known history of chronic viral hepatitis
• Creatine kinase above ULN
• Serum creatinine above ULN
• For females, pregnancy or breast-feeding
• Use of colchicine, methotrexate, azathioprine, or systemic steroids in the two months preceding screening
• Current use of fibrates, including fenofibrates, or simvastatin
• Use of an experimental treatment for PBC
• Use of experimental or unapproved immunosuppressant
• Any other condition(s) that would compromise the safety of the subject or compromise the quality of the clinical study, as judged by the Investigator