Study of INT 747 in Combination With URSO in Patients With Primay Biliary Cirrhosis (PBC)

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Liver Cirrhosis, Biliary

In brief

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.

Key facts

Study ID

NCT00550862

Run by

Intercept Pharmaceuticals

People needed

165

Starts

2007-10-01

Expected to finish

2010-12-01

Last updated by the study team

2024-02-06

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• 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.

You may not qualify if…

• 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.

Where it is running

• U Florida Hepatology — Gainesville, Florida, United States
• University of Miami - Center for Liver Diseases — Miami, Florida, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• Henry Ford Health Center Columbus — Novi, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Saint Louis University — St Louis, Missouri, United States
• Beth Israel Medical Center — New York, New York, United States
• Mt. Sinai School of Medicine — New York, New York, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• UT Southwestern Medical Center — Dallas, Texas, United States
• Baylor College of Medicine — Houston, Texas, United States
• McGuire DVAMC — Richmond, Virginia, United States
• Virginia Mason Medical Center — Seattle, Washington, United States
• Karls-Franzens University — Graz, Austria
• University of Calgary — Calgary, Alberta, Canada
• University of Alberta — Edmonton, Alberta, Canada
• University of Manitoba — Winnipeg, Manitoba, Canada
• University of Toronto Western Hospital — Toronto, Ontario, Canada
• Centre de Recherche du CHUM / University of Montreal — Montreal, Quebec, Canada
• Hopital de l'Hotel Dieu — Lyon, France
• Johann Wolfgang Goethe University — Frankfurt, Germany
• University Medical Centre Hamburg-Eppendorf — Hamburg, Germany
• Medical School of Hannover — Hanover, Germany
• University of Munich — Munich, Germany
• AMC University of Amsterdam — Amsterdam, Netherlands

Full record on ClinicalTrials.gov

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