A study of INT-747 (6-ethyl chenodeoxycholic acid [6-ECDCA]) in combination with ursodeoxycholic acid (UDCA [URSO®]) in patients with primary biliary cirrhosis (PBC)

Intercept Pharmaceuticals (USA)0 个研究点目标入组 140 人开始时间: 2008年8月13日最近更新: 2018年5月28日

试验速览

•1. Male or female age 18 to 70 years
•2. Stable dose of ursodeoxycholic acid (UDCA [URSO®]) for at least six months prior to screening
•3. Female patients must be post-menopausal, surgically sterile, or prepared to use two methods of contraception with all sexual partners during the study and for 14 days after the end of dosing
•4. Male patients must be prepared to use two methods of contraception with all sexual partners during the study and for 14 days after the end of the dosing
•5. Proven or likely PBC, as demonstrated by the patient presenting with at least two of the following three diagnostic factors:
•5.1. History of increased AP levels for at least 6 months prior to Day 0
•5.2. Positive antimitochondrial antibody (AMA) titre (greater than 1:40 titre on immunofluorescence or M2 positive by enzyme-linked immunosorbent assay [ELISA]) or PBC-specific antinuclear antibodies (antinuclear dot and nuclear rim positive)
•5.3. Liver biopsy consistent with PBC
•6. Screening AP value between 1.5 and 10 x upper limit of normal (ULN)

•1. Administration of the following drugs at any time during the three months prior to screening for the study:
•1.1. Colchicine
•1.2. Methotrexate
•1.3. Azathioprine
•1.4. Systemic corticosteroids
•2. Screening conjugated (direct) bilirubin greater than 2 x ULN
•3. Screening alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 5 x ULN
•4. Screening serum creatinine greater than 133 µmol/L (1.5 mg/dL)
•5. History or presence of hepatic decompensation (e.g., variceal bleeds, encephalopathy, or poorly controlled ascites)
•6. History or presence of other concomitant liver diseases including hepatitis due to hepatitis B or C virus (HBV, HCV) infection, primary sclerosing cholangitis (PSC), alcoholic liver disease, definite autoimmune liver disease or biopsy proven nonalcoholic steatohepatitis (NASH)
•7. Pregnancy

发起方

Intercept Pharmaceuticals (USA)