Trial of High-dose Urso in Primary Sclerosing Cholangitis

National Institutes of Health (NIH)

Status and phase

Terminated

Phase 3

Phase 2

Conditions

Primary Sclerosing Cholangitis

Treatments

Drug: Placebo

Drug: Ursodeoxycholic Acid

Study type

Interventional

Funder types

NIH

Identifiers

NCT00059202

URSO (completed)

R01DK056924 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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 transplantation, changes in histology and cholangiogram as well as liver biochemistries and quality of life data collected.

Enrollment

150 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.