A Study of an Investigational Medication in Combination with Ursodeoxycholic Acid

(URSO, UDCA) in Patients with Primary Biliary Cirrhosis

Principal Investigator:   Henry C. Bodenheimer, Jr., MD

Time frame of study:    October 2007 - December 2008

Time frame of participation:   Up to 14 weeks (99 days)

Number of participants needed:   Open

Location of Study:

• Beth Israel Medical Center
• Phillips Ambulatory Care Center
• 10 Union Square East
• New York, NY 10003

Contact Name, Number & Email:

• Clinical Research Coordinator
• Sarah Medina, MD
• (212) 844-6446
• samedina@chpnet.org

Summary:

The Division of Digestive Diseases is currently looking to enroll individuals who are interested in participating in a clinical study to select an optimal dose of an investigational medication, INT-747 (a modified human bile acid), by comparing the effectiveness and safety of 3 INT-747 dose levels to 1 placebo dose level, administered to patients with primary biliary cirrhosis who continue to take ursodeoxycholic acid (URSO, UDCA) .

Criteria for Participation

Patients must be:

• At least 18 to 70 years of age
• On a stable dose of ursodeoxycholic acid (URSO, UDCA) for at least 6 months
• History of elevated alkaline phosphatase (AP) blood levels for at least 6 months
• Not pregnant or breast-feeding
• Not have other liver diseases
• Able to meet other criteria that will be discussed at a screening visit

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