Back to resultsFenofibrate for Patients With Primary Biliary Cirrhosis Who Had An Inadequate Response to Ursodeoxycholic Acid
Primary Purpose
Primary Biliary Cirrhosis
Status
Recruiting
Phase
Phase 3
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 PBC, UDCA, Fenofibrate
Eligibility Criteria
Inclusion Criteria:
- Signed informed consent
- Patient with PBC defined by 2 in 3 of the following criteria: a.Positive antimitochondrial antibody type M2; b.Abnormal serum alkaline phosphatases (ALP > 1,5N) and aminotransferase (AST or ALT > 1N) activities; c.Histological hepatic injuries consistent with PBC.
- Had been treated with UDCA more than 6 months, and failed to achieve a complete biochemical response.
Exclusion Criteria:
- Pregnancy or desire of pregnancy.
- Breast-feeding.
- 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.
- History or presence of hepatic decompensation (e.g., variceal bleeds, encephalopathy, or poorly controlled ascites).
- History of urolithiasis, nephritis or renal failure (clearance of creatinine < 60 ml/mn).
- Hepatotoxic drugs use before recruiting.
- Fenofibrate anaphylaxis.
Sites / Locations
- Xijing HosipitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Fenofibrate + UDCA
Monotherapy
Arm Description
Fenofibrate in combination with ursodeoxycholic acid
UDCA alone
Outcomes
Primary Outcome Measures
Rate of patients with complete biochemical response
Normalization of alkaline phosphatase (ALP) or decrease of ALP by more than 40% compared to the baseline.
Secondary Outcome Measures
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.
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.
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.
Change in serum levels of ALP compared to the baseline.
Absolute change in serum levels of ALP compared to the baseline.
Change in serum levels of bilirubin compared to the baseline.
Absolute change in serum levels of bilirubin compared to the baseline.
Change in serum levels of transaminase compared to the baseline.
Absolute change in serum levels of transaminase compared to the baseline.
Full Information
NCT ID
NCT02823366
First Posted
January 28, 2016
Last Updated
September 27, 2022
Sponsor
Xijing Hospital of Digestive Diseases
1. Study Identification
Unique Protocol Identification Number
NCT02823366
Brief Title
Fenofibrate for Patients With Primary Biliary Cirrhosis Who Had An Inadequate Response to Ursodeoxycholic Acid
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Recruiting
Study Start Date
January 2016 (undefined)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Xijing Hospital of Digestive Diseases
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Biliary Cirrhosis
Keywords
PBC, UDCA, Fenofibrate
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
104 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Fenofibrate + UDCA
Arm Type
Experimental
Arm Description
Fenofibrate in combination with ursodeoxycholic acid
Arm Title
Monotherapy
Arm Type
Active Comparator
Arm Description
UDCA alone
Intervention Type
Drug
Intervention Name(s)
Fenofibrate
Intervention Type
Drug
Intervention Name(s)
UDCA
Primary Outcome Measure Information:
Title
Rate of patients with complete biochemical response
Description
Normalization of alkaline phosphatase (ALP) or decrease of ALP by more than 40% compared to the baseline.
Time Frame
Week 24
Secondary Outcome Measure Information:
Title
Change in liver biopsy examinations according to conventional Ludwig system.
Description
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.
Time Frame
Week 48
Title
Change in GLOBE risk scores after treatment.
Description
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.
Time Frame
Week 48
Title
Change in liver stiffness status measured by magnetic resonance elastography.
Description
The change of liver stiffness status at the end of the study compared to baseline checked by magnetic resonance elastography.
Time Frame
Week 48
Title
Change in serum levels of ALP compared to the baseline.
Description
Absolute change in serum levels of ALP compared to the baseline.
Time Frame
Weeks 0, 4, 8, 12, 24, and 48
Title
Change in serum levels of bilirubin compared to the baseline.
Description
Absolute change in serum levels of bilirubin compared to the baseline.
Time Frame
Weeks 0, 4, 8, 12, 24, and 48
Title
Change in serum levels of transaminase compared to the baseline.
Description
Absolute change in serum levels of transaminase compared to the baseline.
Time Frame
Weeks 0, 4, 8, 12, 24, and 48
Other Pre-specified Outcome Measures:
Title
Change in symptom-pruritus.
Description
The symptom of pruritus will be evaluated by questionnaire before enrolment and at the end of the study.
Time Frame
Week 24
Title
Change in symptom-fatigue.
Description
The symptom of fatigue will be evaluated by Fatigue Impact Scale before enrolment and at the end of the study.
Time Frame
Week 24
Title
Change in serum Immunoglobulin M Levels.
Description
Absolute change in serum levels of Immunoglobulin M compared to the baseline.
Time Frame
Week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Signed informed consent
Patient with PBC defined by 2 in 3 of the following criteria: a.Positive antimitochondrial antibody type M2; b.Abnormal serum alkaline phosphatases (ALP > 1,5N) and aminotransferase (AST or ALT > 1N) activities; c.Histological hepatic injuries consistent with PBC.
Had been treated with UDCA more than 6 months, and failed to achieve a complete biochemical response.
Exclusion Criteria:
Pregnancy or desire of pregnancy.
Breast-feeding.
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.
History or presence of hepatic decompensation (e.g., variceal bleeds, encephalopathy, or poorly controlled ascites).
History of urolithiasis, nephritis or renal failure (clearance of creatinine < 60 ml/mn).
Hepatotoxic drugs use before recruiting.
Fenofibrate anaphylaxis.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ying Han, Ph.D
Phone
86-29-84771539
Email
hanying@fmmu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Yongquan Shi, Ph.D
Phone
86-29-84771515
Email
shiyquan@fmmu.edu.cn
Facility Information:
Facility Name
Xijing Hosipital
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ying Han, Ph.D
Phone
86-29-84771539
Email
hanying@fmmu.edu.cn
First Name & Middle Initial & Last Name & Degree
Yongquan Shi, Ph.D
Phone
86-29-84771515
Email
shiyquan@fmmu.edu.cn
12. IPD Sharing Statement
Learn more about this trial
Fenofibrate for Patients With Primary Biliary Cirrhosis Who Had An Inadequate Response to Ursodeoxycholic Acid
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