Clinical Trial: Trial of High-dose Urso in Primary Sclerosing Cholangitis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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.

Detailed Summary:
Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Current Primary Outcome: To complete the evaluation of the effects of urso at a dose of 28-30 mg/kg/day on time to the development of cirrhosis, varices, cholangiocarcinoma, meeting minimal listing criteria for liver transplantation, or death in patients with PSC. [ Time Frame: 5 years ]

Original Primary Outcome:

Current Secondary Outcome: Compare high dose urso vs placebo on liver biochemistries, histology stage, cholangiography, Mayo Risk Score, quality of life, toxicity, tolerability, development of cholangitis. Establish a serum, tissue & data bank for future studies. [ Time Frame: 5 years ]

Original Secondary Outcome:

Information By: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Dates:
Date Received: April 21, 2003
Date Started:
Date Completion:
Last Updated: October 31, 2013
Last Verified: October 2013