Efficacy and Safety of Fenofibrate Combined With UDCA in PBC Patients With an Incomplete Biochemical Response to UDCA
Study Details
Study Description
Brief Summary
The purpose of this protocol is to conduct a trial in a selected population of patients with PBC based on an incomplete biochemical response after 12 months of UDCA therapy.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1/Phase 2 |
Detailed Description
Primary biliary cholangitis is a chronic cholestatic liver disease, ursodeoxycholic acid (UDCA) is the only drug approved for the treatment of PBC. Although UDCA can improve the clinical outcomes in patients with PBC, about 40% of PBC patients show an incomplete biochemical response to this treatment, accordingly have a significantly increased risk of developing liver transplantation or death. Therefor there is a urgently needed for better therapies for these patients. The development of new treatments is therefore needed. The Fenofibrate is the candidate, there is now a substantial body of circumstantial evidence supporting that Fenofibrate is well tolerated and can improve biochemical response in PBC patients with incompleted response to UDCA. The purpose of this protocol is to conduct a trial in a selected population of patients with PBC based on an incomplete biochemical response after 12 months of UDCA therapy.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: UDCA Standard treatment All subjects will reiceive UDCA at a dose of 13-15mg/kg/d by oral for 12 months, and UDCA will be maintained after 12 months. |
Drug: UDCA
Ursodeoxycholic acid，the abbreviation UDCA, is one of the secondary bile acids, which are metabolic byproducts of intestinal bacteria，it is the only FDA approved drug to treat PBC.
Other Names:
|
| Experimental: Fenofibrate Combined with UDCA Treatment All subjects will be treated with UDCA,13-15mg/kg/d, and Fenofibrate, 200mg/d by oral for 12 month, |
Drug: Fenofibrate
Fenofibrate is a drug of the fibrate class. it reduces both low-density lipoprotein (LDL) and very low density lipoprotein (VLDL) levels, as well as increasing high-density lipoprotein (HDL) levels and reducing triglyceride levels.
Other Names:
Drug: UDCA
Ursodeoxycholic acid，the abbreviation UDCA, is one of the secondary bile acids, which are metabolic byproducts of intestinal bacteria，it is the only FDA approved drug to treat PBC.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Serum Level of Alkaline Phosphatase(ALP) value [12 months]
To analyze the clinical efficacy of UDCA combined with UDCA at 1 year compared to baseline values.
Secondary Outcome Measures
- Total bilirubin(TBIL) value [12 months]
To analyze the clinical efficacy of UDCA combined with UDCA at 1 year compared to baseline values.
- Aspartate aminotransferase(AST) value [12 months]
To analyze the clinical efficacy of UDCA combined with UDCA at 1 year compared to baseline values.
- Serum Level of Gamma-glutamyl transpeptidase (GGT) value [12 months]
To analyze the clinical efficacy of UDCA combined with UDCA at 1 year compared to baseline values.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
PBC Patient , previous treatment with UDCA 13-15 mg/kg/day for at least 1 year, showed incomplete biochemical response;
-
Patients who showing an incomplete biochemical response to UDCA as defined by: ALP > 3ULN,AST> 2N ,total bilirubin >17 µmol/l after ≥ 12 months of UDCA at the dose of 13 - 15 mg/kg/day.
3,signed informed consent after careful review of information and study details.
Exclusion Criteria:
-
Hypersensitivity to fenofibrate
-
Administration of the following drugs at any time during the 3 months prior to screening for the study: methotrexate, colchicines, azathioprine, systemic steroids.
-
Decompensation PBC, such as recurrent variceal hemorrhage, uncontrolled encephalopathy or refractory ascites
-
Anticipated need for liver transplantation within one year
-
Co-existing liver diseases such as acute or chronic viral hepatitis, alcoholic liver disease, choledocholithiasis, autoimmune hepatitis, biopsy-proven non-alcoholic fatty liver disease, Wilson's disease and hemochromatosis
-
Acute or chronic renal failure
-
Known history of cholecystitis with intact gallbladder
-
Pregnant or nursing women
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Beijing 302 hospital | Beijing | China | 100039 |
Sponsors and Collaborators
- Beijing 302 Hospital
Investigators
- Study Director: Zhengsheng Zou, Dr., Beijing 302 Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BJ302-FGRXGB-002