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Richmond, Virginia

  • Sclerosing Cholangitis

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.


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.


Study is Available At:


Original ID:

URSO (completed)


NCT ID:

NCT00059202


Secondary ID:

R01DK056924


Study Acronym:


Brief Title:

Trial of High-dose Urso in Primary Sclerosing Cholangitis


Official Title:

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


Overall Status:

Completed


Study Phase:

Phase 2/Phase 3


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

75 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: S


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

150


Enrollment Type:


Study Dates

Verification Date:October 2013
Last Changed Date:October 31, 2013
First Received Date:April 21, 2003

Study Outcomes

Outcome Type:Primary Outcome
Measure: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
Safety Issues:True
Outcome Type:Secondary Outcome
Measure: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
Safety Issues:True

Study Interventions

Intervention Type:Drug
Name:Ursodeoxycholic Acid

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:NIH
Agency Type:Lead Sponsor
Agency Name:National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: April 03, 2020

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