Trial of High-dose Urso in Primary Sclerosing Cholangitis

Primary Sclerosing Cholangitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00059202
• Other study ID #: URSO (completed)
• Secondary ID: R01DK056924
• Status: Terminated
• Phase: Phase 2/Phase 3
• Start date: July 2002
• Est. completion date: June 2008

Study information

• Verified date: April 2021
• Source: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 150
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

• 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.

Related Conditions & MeSH terms

• Cholangitis
• Cholangitis, Sclerosing
• Primary Sclerosing Cholangitis

Intervention

Drug:
• Ursodeoxycholic Acid
Ursodeoxycholic Acid 28-30 mg/kg/day in divided doses
• Placebo
Placebo for Urso

Locations

Country	Name	City	State
United States	Mayo Clinic	Jacksonville	Florida
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	Medical College of Virginia	Richmond	Virginia
United States	Mayo Clinic	Rochester	Minnesota
United States	St. Louis University	Saint Louis	Missouri
United States	Mayo Clinic	Scottsdale	Arizona
United States	University of Washington	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Lindor KD, Kowdley KV, Luketic VA, Harrison ME, McCashland T, Befeler AS, Harnois D, Jorgensen R, Petz J, Keach J, Mooney J, Sargeant C, Braaten J, Bernard T, King D, Miceli E, Schmoll J, Hoskin T, Thapa P, Enders F. High-dose ursodeoxycholic acid for the — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Treatment Failure	Treatment failure was defined as death, transplantation, meeting minimal listing criteria, development of varices, cholangiocarcinoma, or progression to cirrhosis	5 years
Secondary	Number of Deaths	Death at any time up to 5 years	5 years
Secondary	Number of Participants Who Have a Liver Transplantation	Liver transplantation at any time up to 5 years	5 years
Secondary	Number of Participants Meeting Minimal Listing Criteria for Liver Transplantation	Meeting minimal listing criteria for liver transplantation at any time up to 5 years. Minimal listing criteria are defined as a MELD score of 14 or higher. The Model For End-Stage Liver Disease (MELD) is a numeric score with a range of 6 to 40, where a higher score means worse liver disease.	5 years
Secondary	Number of Participants Who Developed Cholangiocarcinoma	Development of cholangiocarcinoma at any time up to 5 years	5 years
Secondary	Number of Participants Who Developed Varices	Development of esophogeal and/or gastric varices	5 years
Secondary	Number of Participants Who Developed Cirrhosis	Development of cirrhosis based on liver biopsy	5 years
Secondary	Alkaline Phosphatase at 12 Months	Alkaline phosphatase divided by the upper limit of normal	12 months
Secondary	Alkaline Phosphatase at 24 Months	Alkaline phosphatase divided by the upper limit of normal	24 months
Secondary	Alkaline Phosphatase at 36 Months	Alkaline phosphatase divided by the upper limit of normal	36 months
Secondary	Aspartate Aminotransferase at 12 Months	Aspartate aminotransferase at divided by the upper limit of normal	12 months
Secondary	Aspartate Aminotransferase at 24 Months	Aspartate aminotransferase at divided by the upper limit of normal	24 months
Secondary	Aspartate Aminotransferase at 36 Months	Aspartate aminotransferase at divided by the upper limit of normal	36 months
Secondary	Bilirubin at 12 Months	Bilirubin divided by the upper limit of normal	12 months
Secondary	Bilirubin at 24 Months	Bilirubin divided by the upper limit of normal	24 months
Secondary	Bilirubin at 36 Months	Bilirubin divided by the upper limit of normal	36 months