Trial of High-dose Urso in Primary Sclerosing Cholangitis
Primary Sclerosing Cholangitis
About this trial
This is an interventional treatment trial for Primary Sclerosing Cholangitis focused on measuring Urso, PSC
Eligibility 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.
Sites / Locations
- Mayo Clinic
- Mayo Clinic
- Mayo Clinic
- St. Louis University
- University of Nebraska Medical Center
- Medical College of Virginia
- University of Washington
Arms of the Study
Arm 1
Arm 2
Placebo Comparator
Experimental
Placebo
Ursodeoxycholic acid
Placebo tablet that is identical (size, color, etc) to experimental ursodeoxycholic acid tablet.
Ursodeoxycholic acid 28-30 mg/kg/day