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The goal of this clinical trial is to learn if the drug Fenofibrate works to treat adults with a liver disease called Primary Biliary Cholangitis (PBC) who have not received previous treatment. It will also learn about the safety of Fenofibrate. The main questions it aims to answer are:
Is Fenofibrate better at helping the liver return to normal function (measured by a blood test called ALP) than the standard medication, Ursodeoxycholic What kind of medical problems do participants have when taking Fenofibrate compared to those taking UDCA?
Researchers will compare Fenofibrate to the active drug UDCA (the current standard treatment) to see which one works better.**
Participants will:
Be randomly assigned to take either Fenofibrate plus a UDCA placebo, or UDCA plus a Fenofibrate placebo, every day for 12 months. (Neither they nor their doctor will know which group they are in.) Visit the clinic 5 times over the year (at 1, 3, 6, 9, and 12 months) for check-ups, blood tests, and questionnaires.
Undergo a special scan (like FibroScan) to measure liver stiffness at some visits.
Be encouraged to have a liver biopsy at the start and end of the study to provide detailed information about liver health (this is optional).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fenofibrate | Experimental |
| |
| UDCA | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fenofibrate | Drug | Fenofibrate 200mg+placebo |
| |
| UDCA (Ursodeoxycholic acid) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with Normal ALP level | at 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with both ALP and total bilirubin normalisation | 12 months | |
| Percentage of participants with ALP normalization | 1, 3, 6, and 9 months of treatment | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xijing Hospital | Recruiting | Xi'an | Shaanxi | 710032 | China |
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| ID | Term |
|---|---|
| D008105 | Liver Cirrhosis, Biliary |
| ID | Term |
|---|---|
| D002780 | Cholestasis, Intrahepatic |
| D002779 | Cholestasis |
| D001649 | Bile Duct Diseases |
| D001660 | Biliary Tract Diseases |
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| ID | Term |
|---|---|
| D011345 | Fenofibrate |
| D014580 | Ursodeoxycholic Acid |
| ID | Term |
|---|---|
| D058607 | Fibric Acids |
| D058610 | Isobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
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| Drug |
UDCA13-15mg/kg/day+placebo |
|
| Absolute and relative changes in ALP compared to baseline |
| 1, 3, 6, 9, and 12 months of treatment |
| Changes in ALT compared to baseline | 1, 3, 6, 9, and 12 months of treatment |
| Changes in AST compared to baseline | 1, 3, 6, 9, and 12 months of treatment |
| Changes in GGT compared to baseline | 1, 3, 6, 9, and 12 months of treatment |
| Changes in TB compared to baseline | 1, 3, 6, 9, and 12 months of treatment |
| Changes in itch NRS compared to baseline | 1, 3, 6, 9, and 12 months of treatment |
| Changes in liver stiffness compared to baseline | FibroScan was used to detect the liver stiffness , and the stiffness values before and after treatment were compared | 1, 3, 6, 9, and 12 months of treatment |
| Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.0 | From enrollment to the end of treatment at 12 months |
| D004066 |
| Digestive System Diseases |
| D008107 | Liver Diseases |
| D008103 | Liver Cirrhosis |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| 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 |
| D003840 | Deoxycholic Acid |
| D002793 | Cholic Acids |
| D001647 | Bile Acids and Salts |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D002757 | Cholanes |