Trial of High-dose Urso in Primary Sclerosing Cholangitis
- Conditions
- Primary Sclerosing Cholangitis
- Interventions
- Drug: Placebo
- Registration Number
- NCT00059202
- 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
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 150
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ursodeoxycholic acid Ursodeoxycholic Acid Ursodeoxycholic acid 28-30 mg/kg/day Placebo Placebo Placebo tablet that is identical (size, color, etc) to experimental ursodeoxycholic acid tablet.
- Primary Outcome Measures
Name Time Method Number of Participants With Treatment Failure 5 years Treatment failure was defined as death, transplantation, meeting minimal listing criteria, development of varices, cholangiocarcinoma, or progression to cirrhosis
- Secondary Outcome Measures
Name Time Method Number of Participants Who Have a Liver Transplantation 5 years Liver transplantation at any time up to 5 years
Number of Participants Who Developed Varices 5 years Development of esophogeal and/or gastric varices
Alkaline Phosphatase at 36 Months 36 months Alkaline phosphatase divided by the upper limit of normal
Number of Deaths 5 years Death at any time up to 5 years
Aspartate Aminotransferase at 24 Months 24 months Aspartate aminotransferase at divided by the upper limit of normal
Number of Participants Meeting Minimal Listing Criteria for Liver Transplantation 5 years 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.
Number of Participants Who Developed Cholangiocarcinoma 5 years Development of cholangiocarcinoma at any time up to 5 years
Alkaline Phosphatase at 24 Months 24 months Alkaline phosphatase divided by the upper limit of normal
Number of Participants Who Developed Cirrhosis 5 years Development of cirrhosis based on liver biopsy
Bilirubin at 12 Months 12 months Bilirubin divided by the upper limit of normal
Bilirubin at 36 Months 36 months Bilirubin divided by the upper limit of normal
Alkaline Phosphatase at 12 Months 12 months Alkaline phosphatase divided by the upper limit of normal
Bilirubin at 24 Months 24 months Bilirubin divided by the upper limit of normal
Aspartate Aminotransferase at 12 Months 12 months Aspartate aminotransferase at divided by the upper limit of normal
Aspartate Aminotransferase at 36 Months 36 months Aspartate aminotransferase at divided by the upper limit of normal
Trial Locations
- Locations (5)
St. Louis University
🇺🇸Saint Louis, Missouri, United States
Medical College of Virginia
🇺🇸Richmond, Virginia, United States
University of Washington
🇺🇸Seattle, Washington, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States