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| Name | Class |
|---|---|
| University of Florida | OTHER |
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The purpose of this study is to determine whether fenofibrate is safe and effective in the treatment primary sclerosing cholangitis (PSC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fenofibrate | Experimental | fenofibrate 160 mg po daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fenofibrate | Drug | 160 mg po daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serum Alkaline Phosphatase | Serum alkaline phosphatase will be measured at entry and end of study | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mayo Risk Score for Primary Sclerosing Cholangitis | The Mayo risk score (MRS), which is a composite of several variables (age, bilirubin, albumin, aspartate aminotransferase[AST] and h/o variceal bleeding), will be measured at entry and end of study. The MRS is a mathematically calculated risk score. MRS does not have a theoretical lower/upper bound (that is, no theoretical minimum and maximum values). Mayo risk score <=0 indicates low risk of death. MRS between 0 and 2 indicates intermediate risk, and greater than 2 indicates high risk. There is no known range for this score. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cynthia Levy, MD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Gainesville | Florida | 32608 | United States | ||
| University of Miami |
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| ID | Title | Description |
|---|---|---|
| FG000 | Fenofibrate | fenofibrate 160 mg po daily |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Fenofibrate | fenofibrate 160 mg po daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Serum Alkaline Phosphatase | Serum alkaline phosphatase will be measured at entry and end of study | Posted | Median | Standard Error | U/L | 6 months |
|
|
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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 | Fenofibrate | fenofibrate 160 mg po daily |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| worsening of psoriasis | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Only 1 patient had psoriasis at baseline, and therefore only 1 patient was at risk for worsening of Psoriasis. Of note, none of the other 7 patients developed new psoriasis. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Cynthia Levy | University of Miami | 305-243-2147 | clevy@med.miami.edu |
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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 |
|---|---|
| D011345 | Fenofibrate |
| ID | Term |
|---|---|
| D058607 | Fibric Acids |
| D058610 | Isobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
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| 6 months |
| Miami |
| Florida |
| 33136 |
| United States |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Mayo Risk Score for Primary Sclerosing Cholangitis | The Mayo risk score (MRS), which is a composite of several variables (age, bilirubin, albumin, aspartate aminotransferase[AST] and h/o variceal bleeding), will be measured at entry and end of study. The MRS is a mathematically calculated risk score. MRS does not have a theoretical lower/upper bound (that is, no theoretical minimum and maximum values). Mayo risk score <=0 indicates low risk of death. MRS between 0 and 2 indicates intermediate risk, and greater than 2 indicates high risk. There is no known range for this score. | Median baseline MRS was compared to Median MRS after 6 months of study drug | Posted | Median | Full Range | score | 6 months |
|
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|
|
| 0 |
| 8 |
| 1 |
| 8 |
|
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| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010647 | Phenyl Ethers |
| D004987 | Ethers |
| D001577 | Benzophenones |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010636 | Phenols |
| D007659 | Ketones |