Trial of High-Dose Urso in Primary Sclerosing Cholangitis - Tabular View

Tracking Information
First Received Date ^ICMJE	April 21, 2003
Last Updated Date	October 31, 2008
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE (submitted: October 31, 2008)	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 ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00059202 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: October 31, 2008)	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 ]
Original Secondary Outcome Measures ^ICMJE	Same as current

Descriptive Information
Brief Title ^ICMJE	Trial of High-Dose Urso in Primary Sclerosing Cholangitis
Official Title ^ICMJE	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 Description
Study Phase	Phase II, Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
Condition ^ICMJE	Sclerosing Cholangitis
Intervention ^ICMJE	Drug: Ursodeoxycholic Acid
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	150
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years to 75 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00059202
Responsible Party
Study ID Numbers ^ICMJE	URSO
Study Sponsor ^ICMJE	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Verification Date	October 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP