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URL: http://clinicaltrials.gov/show/NCT00059202
Proper Citation: High-dose Ursodiol Therapy of Primary Sclerosing Cholangitis (RRID:SCR_006772)
Description: Multi-center, placebo-controlled trial of ursodiol in primary sclerosing cholangitis (PSC). A total of 150 patients with previously untreated PSC without cirrhosis were randomly assigned to receive high doses of ursodiol (20-25 mg/kg/day) or placebo for two years. Patients underwent medical evaluation, endoscopic retrograde cholangiography, and liver biopsy before randomization and again at two-year intervals. The endpoints of therapy were progression of hepatic fibrosis, liver decompensation, liver transplantation, or death. The treatment phase of the study was stopped for futility in June 2008; however, patients continue to be followed. Ongoing mechanistic studies are underway.
Abbreviations: HUSC
Synonyms: Trial of High-dose Urso in Primary Sclerosing Cholangitis, High-dose Ursodiol Therapy of Primary Sclerosing Cholangitis (HUSC), Multicentered Randomized Trial of High-dose Urso in Primary Sclerosing Cholangitis
Resource Type: clinical trial, resource
Defining Citation: PMID:19585548
Keywords: treatment, placebo, ursodeoxycholic acid, intervention, randomized, adult human, male, female
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