Fenofibrate for Patients With Primary Biliary Cirrhosis Who Had An Inadequate Response to Ursodeoxycholic Acid

NCT02823366 · tracked via the Priya Life Science China tracker

Sponsor

Xijing Hospital of Digestive Diseases

Phase

Phase 3

Started

2016-01

Last updated

2026-10-30

Condition(s) studied

Primary Biliary Cirrhosis

Investigational drug(s) / intervention(s)

Fenofibrate →UDCA →

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

70 Years

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 or ALT \> 1N) activities; c.Histological hepatic injuries consistent with PBC. 3. Had been treated with UDCA more than 6 months, and failed to achieve a complete biochemical response. 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.

Primary outcome measure(s)

Rate of patients with complete biochemical response — Week 24
Normalization of alkaline phosphatase (ALP) or decrease of ALP by more than 40% compared to the baseline.

Trial sites (1)

Facility	City	Region	Status
Xijing Hosipital	Xi'an	Shaanxi	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02823366 on ClinicalTrials.gov ↗ ← All trials in China