Clinical Studies
Breast Care
Cardiology
Colon Cancer
Dermatology
Diabetes
Gastrointestinal
HIV/AIDS
Mental Health
Neurology
Obesity/Weight Management
Women's Health
Other
Special Features
Advances/Research
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: | 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 conducting a clinical
study to select an optimal dose of an investigational medication, INT-747,
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 are currently taking ursodeoxycholic acid (URSO, UDCA)
Criteria for
Participation:
Patients must be:
• At least 18 to 70 years of age
• 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 a history or presence of other liver diseases
• Able to meet other criteria that will be discussed at a screening
visit