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Sponsors and Collaborators: |
University of Florida PBCers Organization Sciele Pharma |
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Information provided by: | University of Florida |
ClinicalTrials.gov Identifier: | NCT00575042 |
This is a pilot study to evaluate the safety and efficacy of fenofibrate on patients with primary biliary cirrhosis who have an incomplete response to ursodeoxycholic acid.
Condition | Intervention | Phase |
---|---|---|
Primary Biliary Cirrhosis |
Drug: Fenofibrate (Insoluble Drug Delivery-Micro Particle Fenofibrate (IDD-P) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Pilot Study of Fenofibrate for Primary Biliary Cirrhosis |
Estimated Enrollment: | 20 |
Study Start Date: | August 2007 |
Estimated Study Completion Date: | August 2010 |
This is a multicenter open label pilot study to evaluate the efficacy of fenofibrate in 20 patients with PBC treated for 1 year. A randomized design would not be feasible at this stage of the research. Two sites are enrolling patients: University of Florida, Gainesville, and Mayo Clinic Rochester, with the first as the coordinating site. The total number of patients to start treatment will not exceed 20. Our endpoints are 1) surrogate markers of disease activity -serum alkaline phosphatase and immunoglobulin M; 2) a well validated prognostic index -Mayo risk score and 3) the NIDDK quality of life questionnaire.
Ages Eligible for Study: | 21 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria
Contact: Cynthia Levy, MD | 352-376-1611 ext 7-5446 | cynthia.levy@medicine.ufl.edu |
Contact: Joy Peter, RN, BSN, CCRC | (352)392-7956 | joy.peter@medicine.ufl.edu |
United States, Florida | |
University of Florida | Recruiting |
Gainesville, Florida, United States, 32610 | |
Contact: Cynthia Levy, MD 352-376-1611 ext 7-5446 cynthia.levy@medicine.ufl.edu | |
Contact: Joy Peter, RN, BSN, CCRC 352-392-7956 joy.peter@medicine.ufl.edu | |
Principal Investigator: Cynthia Levy, MD | |
United States, Minnesota | |
Mayo Clinic | Recruiting |
Rochester, Minnesota, United States, 55905 | |
Contact: Roberta Jorgensen 507-538-0678 jorgensen.roberta@mayo.edu | |
Contact: Jill Keach (507)538-0678 keach.jill@mayo.edu | |
Principal Investigator: Keith Lindor, MD |
Principal Investigator: | Cynthia Levy, MD | University of Florida |
Responsible Party: | University of Florida ( Cythia Levy, MD ) |
Study ID Numbers: | 405-2006 |
Study First Received: | December 13, 2007 |
Last Updated: | December 13, 2007 |
ClinicalTrials.gov Identifier: | NCT00575042 History of Changes |
Health Authority: | United States: Food and Drug Administration; United States: University of Florida Health Center Institutional Review Board |
PBC Primary Biliary Cirrhosis Fenofibrate Triglide |
Antimetabolites Liver Diseases Biliary Cirrhosis Fibrosis Cholestasis Antilipemic Agents Liver Cirrhosis |
Procetofen Primary Biliary Cirrhosis Cholestasis, Intrahepatic Digestive System Diseases Bile Duct Diseases Biliary Tract Diseases Liver Cirrhosis, Biliary |
Antimetabolites Liver Diseases Molecular Mechanisms of Pharmacological Action Fibrosis Cholestasis Antilipemic Agents Liver Cirrhosis Procetofen |
Pharmacologic Actions Cholestasis, Intrahepatic Digestive System Diseases Pathologic Processes Bile Duct Diseases Therapeutic Uses Biliary Tract Diseases Liver Cirrhosis, Biliary |