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Trial of High-dose Urso in Primary Sclerosing Cholangitis

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ClinicalTrials.gov Identifier: NCT00059202
Recruitment Status : Completed
First Posted : April 22, 2003
Last Update Posted : November 1, 2013
Sponsor:
Information provided by (Responsible Party):
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

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.

Condition or disease Intervention/treatment Phase
Sclerosing Cholangitis Drug: Ursodeoxycholic Acid Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Multicentered Randomized Trial of High-dose Urso in Primary Sclerosing Cholangitis





Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00059202


Locations
United States, Arizona
Mayo Clinic
Scottsdale, Arizona, United States
United States, Florida
Mayo Clinic
Jacksonville, Florida, United States
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Missouri
St. Louis University
St. Louis, Missouri, United States
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States
United States, Virginia
Medical College of Virginia
Richmond, Virginia, United States
United States, Washington
University of Washington
Seattle, Washington, United States
Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Responsible Party: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT00059202     History of Changes
Other Study ID Numbers: URSO (completed)
R01DK056924 ( U.S. NIH Grant/Contract )
First Posted: April 22, 2003    Key Record Dates
Last Update Posted: November 1, 2013
Last Verified: October 2013

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
Urso
PSC

Additional relevant MeSH terms:
Cholangitis
Cholangitis, Sclerosing
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Ursodeoxycholic Acid
Cholagogues and Choleretics
Gastrointestinal Agents