Efficacy and Safety of Fenofibrate Combined With UDCA in PBC Patients With an Incomplete Biochemical Response to UDCA

Beijing 302 Hospital

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Primary Biliary Cirrhosis

Interventions

FenofibrateDRUG

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.

UDCADRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. PBC Patient , previous treatment with UDCA 13-15 mg/kg/day for at least 1 year, showed incomplete biochemical response; 2. 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: 1. Hypersensitivity to fenofibrate 2. Administration of the following drugs at any time during the 3 months prior to screening for the study: methotrexate, colchicines, azathioprine, systemic steroids. 3. Decompensation PBC, such as recurrent variceal hemorrhage, uncontrolled encephalopathy or refractory ascites 4. Anticipated need for liver transplantation within one year 5. 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 6. Acute or chronic renal failure 7. Known history of cholecystitis with intact gallbladder 8. Pregnant or nursing women

Locations (1)

Beijing 302 hospital

Beijing, China

Outcomes

Primary Outcomes

Serum Level of Alkaline Phosphatase(ALP) value

To analyze the clinical efficacy of UDCA combined with UDCA at 1 year compared to baseline values.

Time frame: 12 months

Secondary Outcomes

Total bilirubin(TBIL) value

To analyze the clinical efficacy of UDCA combined with UDCA at 1 year compared to baseline values.

Time frame: 12 months

Aspartate aminotransferase(AST) value

To analyze the clinical efficacy of UDCA combined with UDCA at 1 year compared to baseline values.

Time frame: 12 months

Serum Level of Gamma-glutamyl transpeptidase (GGT) value

To analyze the clinical efficacy of UDCA combined with UDCA at 1 year compared to baseline values.

Time frame: 12 months

Data from ClinicalTrials.gov

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