Efficacy and Safety of Fenofibrate Combined With UDCA in PBC Patients With an Incomplete Biochemical Response to UDCA
Primary Purpose
Primary Biliary Cirrhosis
Status
Withdrawn
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Fenofibrate
UDCA
Sponsored by
About this trial
This is an interventional treatment trial for Primary Biliary Cirrhosis focused on measuring UDCA, Fenofibrate
Eligibility 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
Sites / Locations
- Beijing 302 hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
UDCA Standard treatment
Fenofibrate Combined with UDCA Treatment
Arm Description
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.
All subjects will be treated with UDCA,13-15mg/kg/d, and Fenofibrate, 200mg/d by oral for 12 month,
Outcomes
Primary Outcome Measures
Serum Level of Alkaline Phosphatase(ALP) value
To analyze the clinical efficacy of UDCA combined with UDCA at 1 year compared to baseline values.
Secondary Outcome Measures
Total bilirubin(TBIL) value
To analyze the clinical efficacy of UDCA combined with UDCA at 1 year compared to baseline values.
Aspartate aminotransferase(AST) value
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
To analyze the clinical efficacy of UDCA combined with UDCA at 1 year compared to baseline values.
Full Information
NCT ID
NCT02965911
First Posted
November 15, 2016
Last Updated
September 12, 2021
Sponsor
Beijing 302 Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02965911
Brief Title
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
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Withdrawn
Why Stopped
No participants enrolled
Study Start Date
January 2016 (undefined)
Primary Completion Date
September 8, 2021 (Anticipated)
Study Completion Date
September 8, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing 302 Hospital
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Biliary Cirrhosis
Keywords
UDCA, Fenofibrate
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
UDCA Standard treatment
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Fenofibrate Combined with UDCA Treatment
Arm Type
Experimental
Arm Description
All subjects will be treated with UDCA,13-15mg/kg/d, and Fenofibrate, 200mg/d by oral for 12 month,
Intervention Type
Drug
Intervention Name(s)
Fenofibrate
Other Intervention Name(s)
Antara, Fenoglide, Fibricor, Lipofen, Lofibra
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
UDCA
Other Intervention Name(s)
Ursa,Urso, Urso Forte, Ursocol, Ursofalk,
Intervention Description
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.
Primary Outcome Measure Information:
Title
Serum Level of Alkaline Phosphatase(ALP) value
Description
To analyze the clinical efficacy of UDCA combined with UDCA at 1 year compared to baseline values.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Total bilirubin(TBIL) value
Description
To analyze the clinical efficacy of UDCA combined with UDCA at 1 year compared to baseline values.
Time Frame
12 months
Title
Aspartate aminotransferase(AST) value
Description
To analyze the clinical efficacy of UDCA combined with UDCA at 1 year compared to baseline values.
Time Frame
12 months
Title
Serum Level of Gamma-glutamyl transpeptidase (GGT) value
Description
To analyze the clinical efficacy of UDCA combined with UDCA at 1 year compared to baseline values.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhengsheng Zou, Dr.
Organizational Affiliation
Beijing 302 Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Beijing 302 hospital
City
Beijing
ZIP/Postal Code
100039
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy and Safety of Fenofibrate Combined With UDCA in PBC Patients With an Incomplete Biochemical Response to UDCA
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