Study of INT-747 in combination with ursodeoxycholic acid (UDCA [URSO®]) in patients with primary biliary cirrhosis (PBC)

Not Applicable

Completed

• Conditions: Primary biliary cirrhosis; Digestive System; Fibrosis and cirrhosis of liver

• Registration Number: ISRCTN67465025
• Lead Sponsor: Intercept Pharmaceuticals (USA)

Brief Summary

2015 results in: https://www.ncbi.nlm.nih.gov/pubmed/25500425

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-08-13
• Study Completion: 2010-12-02
• Last Update Posted: 28 May 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

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)

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified