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Fenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cirrhosis

Primary Purpose

Primary Biliary Cirrhosis

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Fenofibrate
UDCA
Sponsored by
Xijing Hospital of Digestive Diseases
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Biliary Cirrhosis focused on measuring PBC, UDCA, Fenofibrate

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Signed informed consent
  2. 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/ALT > 1N) activities; c.Histological hepatic injuries consistent with PBC.

Exclusion Criteria:

  1. Pregnancy or desire of pregnancy.
  2. Breast-feeding.
  3. 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
  4. History or presence of hepatic decompensation (e.g., variceal bleeds, encephalopathy, or poorly controlled ascites).
  5. History of urolithiasis, nephritis or renal failure (clearance of creatinine < 60 ml/mn).
  6. Hepatotoxic drugs use before recruiting.
  7. Fenofibrate anaphylaxis.

Sites / Locations

  • Xijing Hosipital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Fenofibrate + UDCA

Monotherapy

Arm Description

Fenofibrate (200 mg/day) in combination with ursodeoxycholic acid (13-15 mg/kg/day)

UDCA 13-15mg/kg/day

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.
GLOBE risk scores at week 48.
The prognostic scores will be calculated at end of the study by GLOBE scoring system (proposed by Global PBC Study Group), which calculated based on serum values of bilirubin, ALP, albumin and platelet count after 1 year of UDCA therapy 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

First Posted
January 28, 2016
Last Updated
March 6, 2023
Sponsor
Xijing Hospital of Digestive Diseases
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1. Study Identification

Unique Protocol Identification Number
NCT02823353
Brief Title
Fenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cirrhosis
Official Title
Fenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cirrhosis: a Randomized Control Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
April 8, 2016 (Actual)
Primary Completion Date
May 6, 2022 (Actual)
Study Completion Date
June 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Xijing Hospital of Digestive Diseases

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Ursodeoxycholic acid (UDCA) has been the only treatment for primary biliary cirrhosis (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
117 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fenofibrate + UDCA
Arm Type
Experimental
Arm Description
Fenofibrate (200 mg/day) in combination with ursodeoxycholic acid (13-15 mg/kg/day)
Arm Title
Monotherapy
Arm Type
Active Comparator
Arm Description
UDCA 13-15mg/kg/day
Intervention Type
Drug
Intervention Name(s)
Fenofibrate
Intervention Description
Fenofibrate 200mg/day
Intervention Type
Drug
Intervention Name(s)
UDCA
Intervention Description
UDCA 13-15mg/kg/day
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 48
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
GLOBE risk scores at week 48.
Description
The prognostic scores will be calculated at end of the study by GLOBE scoring system (proposed by Global PBC Study Group), which calculated based on serum values of bilirubin, ALP, albumin and platelet count after 1 year of UDCA therapy 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 pruritus.
Description
The symptom of pruritus will be evaluated by questionnaire before enrolment and at the end of the study.
Time Frame
Weeks 48
Title
Change in fatigue.
Description
The symptom of fatigue will be evaluated by Fatigue Impact Scale before enrolment and at the end of the study.
Time Frame
Weeks 48
Title
Change in serum Immunoglobulin M Levels.
Description
Absolute change in serum levels of Immunoglobulin M compared to the baseline.
Time Frame
Week 48

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/ALT > 1N) activities; c.Histological hepatic injuries consistent with PBC. 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.
Facility Information:
Facility Name
Xijing Hosipital
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China

12. IPD Sharing Statement

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Fenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cirrhosis

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