Study of INT 747 in Combination With URSO in Patients With Primay Biliary Cirrhosis (PBC)
Study of INT 747 in Combination With URSO in Patients With Primay Biliary Cirrhosis (PBC)
The primary hypothesis is that INT-747 will cause a reduction in alkaline phosphatase levels
 in Primary Biliary Cirrhosis patients, over a 12 week treatment period, as compared to
 placebo.
None provided
Inclusion Criteria:

 -  Male or female age 18 to 70 years.

 -  Stable dose of ursodeoxycholic acid (URSO, UDCA) for at least 6 months prior to
 screening.

 -  Female patients must be postmenopausal, surgically sterile, or prepared to use 2
 methods of contraception with all sexual partners during the study and for 14 days
 after the end of dosing.

 -  Male patients must be prepared to use 2 methods of contraception with all sexual
 partners during the study and for 14 days after the end of the dosing.

 -  Proven or likely PBC, as demonstrated by the patient presenting with at least 2 of the
 following 3 diagnostic factors:

 1. History of increased AP levels for at least 6 months prior to Day 0

 2. Positive AMA titer (>1:40 titer on immunofluorescence or M2 positive by ELISA) or
 PBC-specific antinuclear antibodies (antinuclear dot and nuclear rim positive)

 3. Liver biopsy consistent with PBC.

 -  Screening AP value between 1.5 and 10 × ULN.

 Exclusion Criteria:

 -  Administration of the following drugs at any time during the 3 months prior to
 screening for the study: colchicine, methotrexate, azathioprine, or systemic
 corticosteroids.

 -  Screening conjugated (direct) bilirubin >2 × ULN.

 -  Screening ALT or AST >5 × ULN.

 -  Screening serum creatinine >1.5 mg/dL (133 mol/L).

 -  History or presence of hepatic decompensation (e.g., variceal bleeds, encephalopathy,
 or poorly controlled ascites).

 -  History or presence of other concomitant liver diseases including hepatitis due to
 hepatitis B or C virus (HCV, HBV) infection, primary sclerosing cholangitis (PSC),
 alcoholic liver disease, definite autoimmune liver disease or biopsy proven
 nonalcoholic steatohepatitis (NASH).

 -  Pregnancy.