Study of INT-747 as Monotherapy in Patients With PBC
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Layout table for eligibility information
Ages Eligible for Study:
18 Years to 70 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Male or female age 18 to 70 years.
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:
History of increased AP levels for at least 6 months prior to Day 0
Positive AMA titer (>1:40 titer on immunofluorescence or M2 positive by ELISA) or PBC-specific antinuclear antibodies (antinuclear dot and nuclear rim positive)
Liver biopsy consistent with PBC
Screening AP value between 1.5 and 10 × ULN
Administration of the following drugs at any time during the 3 months prior to screening for the study: ursodeoxycholic acid (UDCA, URSO®), colchicine, methotrexate, azathioprine, or systemic corticosteroids.
Screening conjugated (direct) bilirubin >2 × ULN.
Screening ALT or AST >5 × ULN.
Screening serum creatinine >133 μmol/L (1.5 mg/dL). 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).