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Ursodeoxycholic acid (UDCA) has been the only treatment for PBC approved by US and European drug administrations. Long-term use of UDCA(13-15 mg/kg/day) in patients with PBC improves serum liver biochemistries and survival free of liver transplantation However, about 40% of patients do not respond to UDCA optimally as assessed by known criteria for biochemical response. Those patients represent the group in need for additional therapies, having increased risk of disease progression and decreased survival free of liver transplantation. Both lab research and some clinical studies suggest that fenofibrate could improve cholestasis in multiple ways including reduce of bile acid synthesis, increase of biliary secretion and anti-inflammation effect. Here we start a random, open and parallel clinical research to explore the effect of fenofibrate in the PBC treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fenofibrate + UDCA | Experimental | Fenofibrate in combination with ursodeoxycholic acid |
|
| Monotherapy | Active Comparator | UDCA alone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fenofibrate | Drug |
| ||
| UDCA |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of patients with complete biochemical response | Normalization of alkaline phosphatase (ALP) or decrease of ALP by more than 40% compared to the baseline. | Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in liver biopsy examinations according to conventional Ludwig system. | Histological evolution will be checked by liver biopsy at the end of the study to compare with baseline histological status. The Ludwig histological classification schemes will be used, which categorised the disease into four stages. | Week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in symptom-pruritus. | The symptom of pruritus will be evaluated by questionnaire before enrolment and at the end of the study. | Week 24 |
| Change in symptom-fatigue. | The symptom of fatigue will be evaluated by Fatigue Impact Scale before enrolment and at the end of the study. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ying Han, Ph.D | Contact | 86-29-84771539 | hanying@fmmu.edu.cn | |
| Yongquan Shi, Ph.D | Contact | 86-29-84771515 | shiyquan@fmmu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xijing Hosipital | 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 |
| ID | Term |
|---|---|
| D058607 | Fibric Acids |
| D058610 | Isobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
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|
| Change in GLOBE risk scores after treatment. |
The prognostic scores will be calculated at entry and end of study by GLOBE scoring system, which calculated based on serum values of bilirubin, ALP, albumin and platelet count after 1 year of treatment and age at baseline. |
| Week 48 |
| Change in liver stiffness status measured by magnetic resonance elastography. | The change of liver stiffness status at the end of the study compared to baseline checked by magnetic resonance elastography. | Week 48 |
| Change in serum levels of ALP compared to the baseline. | Absolute change in serum levels of ALP compared to the baseline. | Weeks 0, 4, 8, 12, 24, and 48 |
| Change in serum levels of bilirubin compared to the baseline. | Absolute change in serum levels of bilirubin compared to the baseline. | Weeks 0, 4, 8, 12, 24, and 48 |
| Change in serum levels of transaminase compared to the baseline. | Absolute change in serum levels of transaminase compared to the baseline. | Weeks 0, 4, 8, 12, 24, and 48 |
| Week 24 |
| Change in serum Immunoglobulin M Levels. | Absolute change in serum levels of Immunoglobulin M compared to the baseline. | Week 24 |
| 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 |