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Trial of High-dose Urso in Primary Sclerosing Cholangitis | Clinical Trials | Clareo Health

TERMINATEDPHASE2/PHASE3

Trial of High-dose Urso in Primary Sclerosing Cholangitis

Multicentered Randomized Trial of High-dose Urso in Primary Sclerosing Cholangitis

NCT00059202•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 transplantation, changes in histology and cholangiogram as well as liver biochemistries and quality of life data collected.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion 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 (7)

Mayo Clinic

Scottsdale, Arizona, United States

Mayo Clinic

Jacksonville, Florida, United States

Mayo Clinic

Rochester, Minnesota, 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

Key Dates

Start Date

July 1, 2002

Primary Completion Date

June 1, 2008

Completion Date

June 1, 2008

Last Updated

May 3, 2021

Enrollment

150

ACTUAL participants

Conditions

Primary Sclerosing Cholangitis

Interventions

Ursodeoxycholic Acid

DRUG

Placebo

DRUG

Characterization of Biliary Cell-derived Organoids From Bile of PSC and Non-PSC Patients

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Primary Sclerosing CholangitisPSC+1 more

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RECRUITING

A-LiNK: Improving Outcomes in Autoimmune Liver Disease

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 3, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Trial of High-dose Urso in Primary Sclerosing Cholangitis

Inclusion Criteria

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