Trial of High-dose Urso in Primary Sclerosing Cholangitis

This study has been completed.

First Received on April 21, 2003. Last Updated on March 15, 2011 History of Changes

Sponsor:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:	NCT00059202

Purpose

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	Intervention	Phase
Sclerosing Cholangitis	Drug: Ursodeoxycholic Acid	Phase II Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Multicentered Randomized Trial of High-dose Urso in Primary Sclerosing Cholangitis

Resource links provided by NLM:

MedlinePlus related topics: Liver Transplantation

Drug Information available for: Ursodeoxycholic acid

U.S. FDA Resources

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:

150

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: 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)

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00059202 History of Changes
Other Study ID Numbers:	URSO (completed)
Study First Received:	April 21, 2003
Last Updated:	March 15, 2011
Health Authority:	United States: Federal Government

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
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012