Clinical trial NCT02965911: Efficacy and Safety of Fenofibrate Combined With UDCA in PBC Patients With an Incomplete Biochemical Response to UDCA
Official title: A Randomized Controlled Clinical Trial on the Efficacy and Safety of Fenofibrate Combined With Ursodeoxycholic Acid in PBC Patients With an Incomplete Biochemical Response to UDCA
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Primary Biliary Cirrhosis
Keywords: UDCA, Fenofibrate
Lead sponsor: Beijing 302 Hospital
Sponsor class: OTHER
First posted: 2016-11-17
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Serum Level of Alkaline Phosphatase(ALP) value
timeFrame: 12 months
Secondary outcomes:
measure: Total bilirubin(TBIL) value
timeFrame: 12 months
measure: Aspartate aminotransferase(AST) value
timeFrame: 12 months
measure: Serum Level of Gamma-glutamyl transpeptidase (GGT) value
timeFrame: 12 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing 302 hospital
Study officials:
affiliation: Beijing 302 Hospital
name: Zhengsheng Zou, Dr.
role: STUDY_DIRECTOR
References: