Trial of High-dose Urso in Primary Sclerosing Cholangitis

Stopped early · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Primary Sclerosing Cholangitis

In brief

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.

Key facts

Study ID

NCT00059202

Run by

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

People needed

150

Starts

2002-07-01

Expected to finish

2008-06-01

Last updated by the study team

2021-05-03

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

Where it is running

• 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

Full record on ClinicalTrials.gov

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