Fenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cirrhosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

117 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-08

Study Completion Date

2022-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Primary Biliary Cirrhosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Fenofibrate + UDCA

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

Group Type EXPERIMENTAL

Fenofibrate

Intervention Type DRUG

Fenofibrate 200mg/day

UDCA

Intervention Type DRUG

UDCA 13-15mg/kg/day

Monotherapy

UDCA 13-15mg/kg/day

Group Type ACTIVE_COMPARATOR

UDCA

Intervention Type DRUG

UDCA 13-15mg/kg/day

Interventions

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Fenofibrate

Fenofibrate 200mg/day

Intervention Type DRUG

UDCA

UDCA 13-15mg/kg/day

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No