Trial of High-Dose Urso in Primary Sclerosing Cholangitis
Information source: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Sclerosing Cholangitis
Intervention: Ursodeoxycholic Acid (Drug)
Phase: Phase 2/Phase 3
Status: Completed
Sponsored by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Summary
This is a multicenter, randomized, controlled trial of high dose ursodiol versus placebo for
patients with primary sclerosing cholangitis (PSC). The average duration of follow-up will
be approximately five years with important clinical endpoints such as death, eligibility for
liver transplanation, changes in histology and cholangiogram as well as liver biochemistries
and quality of life data collected.
Clinical Details
Official title: Multicentered Randomized Trial of High-Dose Urso in Primary Sclerosing Cholangitis
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
- Chronic cholestatic disease of at least six months’ duration.
- Serum alkaline phosphatase at least 1 ½ times the upper limits of normal.
- Retrograde, operative, percutaneous, or magnetic resonance cholangiography
demonstrating intrahepatic and/or extrahepatic biliary duct obstruction, beading, or
narrowing consistent with PSC within one year of the study entry.
- Liver biopsy in the previous one year which is available for review and compatible
with the diagnosis of PSC. Compatible biopsy features include fibrous cholangitis,
ductopenia with periportal inflammation and biliary fibrosis.
Locations and Contacts
Mayo Clinic, Scottsdale, Arizona, United States
Mayo Clinic, Jacksonville, Florida, United States
Mayo Clinic, Rochester, Minnesota 55905, United States
St. Louis University, St. Louis, Missouri, United States
University of Nebraska Medical Center, Omaha, Nebraska, United States
Medical College of Virginia, Richmond, Virginia, United States
University of Washington, Seattle, Washington, United States
Additional Information
Last updated: November 29, 2005
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