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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK056924 | U.S. NIH Grant/Contract | View source |
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DSMB reviewed interim analysis and terminated the study due to futility.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo tablet that is identical (size, color, etc) to experimental ursodeoxycholic acid tablet. |
|
| Ursodeoxycholic acid | Experimental | Ursodeoxycholic acid 28-30 mg/kg/day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ursodeoxycholic Acid | Drug | Ursodeoxycholic Acid 28-30 mg/kg/day in divided doses |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Deaths | Death at any time up to 5 years | 5 years |
| Number of Participants Who Have a Liver Transplantation | Liver transplantation at any time up to 5 years |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Scottsdale | Arizona | United States | |||
| Mayo Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19585548 | Result | 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 treatment of primary sclerosing cholangitis. Hepatology. 2009 Sep;50(3):808-14. doi: 10.1002/hep.23082. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ursodeoxycholic Acid | Ursodeoxycholic Acid 28-30 mg/kg/day in divided doses |
| FG001 | Placebo | Placebo for Urso |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ursodeoxycholic Acid | Ursodeoxycholic Acid 28-30 mg/kg/day in divided doses |
| BG001 | Placebo | Placebo for Urso |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Count of Participants | Participants | 5 years |
|
|
Five years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ursodeoxycholic Acid | Ursodeoxycholic Acid 28-30 mg/kg/day in divided doses | 5 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Keith Lindor | Mayo Clinic | 507-284-2511 |
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| ID | Term |
|---|---|
| D015209 | Cholangitis, Sclerosing |
| ID | Term |
|---|---|
| D002761 | Cholangitis |
| D001649 | Bile Duct Diseases |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D014580 | Ursodeoxycholic Acid |
| ID | Term |
|---|---|
| D003840 | Deoxycholic Acid |
| D002793 | Cholic Acids |
| D001647 | Bile Acids and Salts |
| D013256 | Steroids |
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| Placebo | Drug | Placebo for Urso |
|
| 5 years |
| 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 |
| Number of Participants Who Developed Cholangiocarcinoma | Development of cholangiocarcinoma at any time up to 5 years | 5 years |
| Number of Participants Who Developed Varices | Development of esophogeal and/or gastric varices | 5 years |
| Number of Participants Who Developed Cirrhosis | Development of cirrhosis based on liver biopsy | 5 years |
| Alkaline Phosphatase at 12 Months | Alkaline phosphatase divided by the upper limit of normal | 12 months |
| Alkaline Phosphatase at 24 Months | Alkaline phosphatase divided by the upper limit of normal | 24 months |
| Alkaline Phosphatase at 36 Months | Alkaline phosphatase divided by the upper limit of normal | 36 months |
| Aspartate Aminotransferase at 12 Months | Aspartate aminotransferase at divided by the upper limit of normal | 12 months |
| Aspartate Aminotransferase at 24 Months | Aspartate aminotransferase at divided by the upper limit of normal | 24 months |
| Aspartate Aminotransferase at 36 Months | Aspartate aminotransferase at divided by the upper limit of normal | 36 months |
| Bilirubin at 12 Months | Bilirubin divided by the upper limit of normal | 12 months |
| Bilirubin at 24 Months | Bilirubin divided by the upper limit of normal | 24 months |
| Bilirubin at 36 Months | Bilirubin divided by the upper limit of normal | 36 months |
| Jacksonville |
| Florida |
| United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| St. Louis University | St Louis | Missouri | United States |
| University of Nebraska Medical Center | Omaha | Nebraska | United States |
| Medical College of Virginia | Richmond | Virginia | United States |
| University of Washington | Seattle | Washington | United States |
| drug toxicity |
|
| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| Secondary | Number of Deaths | Death at any time up to 5 years | Posted | Number | participants | 5 years |
|
|
|
| Secondary | Number of Participants Who Have a Liver Transplantation | Liver transplantation at any time up to 5 years | Posted | Number | participants | 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. | Posted | Number | participants | 5 years |
|
|
|
| Secondary | Number of Participants Who Developed Cholangiocarcinoma | Development of cholangiocarcinoma at any time up to 5 years | Posted | Number | participants | 5 years |
|
|
|
| Secondary | Number of Participants Who Developed Varices | Development of esophogeal and/or gastric varices | Posted | Number | participants | 5 years |
|
|
|
| Secondary | Number of Participants Who Developed Cirrhosis | Development of cirrhosis based on liver biopsy | Posted | Number | participants | 5 years |
|
|
|
| Secondary | Alkaline Phosphatase at 12 Months | Alkaline phosphatase divided by the upper limit of normal | Posted | Median | Full Range | Ratio | 12 months |
|
|
|
| Secondary | Alkaline Phosphatase at 24 Months | Alkaline phosphatase divided by the upper limit of normal | Posted | Median | Full Range | Ratio | 24 months |
|
|
|
| Secondary | Alkaline Phosphatase at 36 Months | Alkaline phosphatase divided by the upper limit of normal | Posted | Median | Full Range | Ratio | 36 months |
|
|
|
| Secondary | Aspartate Aminotransferase at 12 Months | Aspartate aminotransferase at divided by the upper limit of normal | Posted | Median | Full Range | Ratio | 12 months |
|
|
|
| Secondary | Aspartate Aminotransferase at 24 Months | Aspartate aminotransferase at divided by the upper limit of normal | Posted | Median | Full Range | Ratio | 24 months |
|
|
|
| Secondary | Aspartate Aminotransferase at 36 Months | Aspartate aminotransferase at divided by the upper limit of normal | Posted | Median | Full Range | Ratio | 36 months |
|
|
|
| Secondary | Bilirubin at 12 Months | Bilirubin divided by the upper limit of normal | Posted | Median | Full Range | Ratio | 12 months |
|
|
|
| Secondary | Bilirubin at 24 Months | Bilirubin divided by the upper limit of normal | Posted | Median | Full Range | Ratio | 24 months |
|
|
|
| Secondary | Bilirubin at 36 Months | Bilirubin divided by the upper limit of normal | Posted | Median | Full Range | Ratio | 36 months |
|
|
|
| 76 |
| 0 |
| 76 |
| 0 |
| 76 |
| EG001 | Placebo | Placebo for Urso | 3 | 74 | 0 | 74 | 0 | 74 |
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| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D002757 | Cholanes |