Skip to main content
OpenTrials
Completed

NCT Number: NCT02823353

Fenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cirrhosis

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Primary Biliary Cirrhosis Bile Duct Diseases Biliary Tract Diseases Cholestasis Cholestasis, Intrahepatic Digestive System Diseases Fibrosis Liver Cirrhosis Liver Cirrhosis, Biliary Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Xijing Hosipital

Xi'an, Shaanxi, 710032, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

fenofibrate

Drug

Fenofibrate 200mg/day

UDCA

Drug

UDCA 13-15mg/kg/day

Primary outcomes

  1. Rate of patients with complete biochemical response

    Time frame: Week 48

    Normalization of alkaline phosphatase (ALP) or decrease of ALP by more than 40% compared to the baseline.

Secondary outcomes

  1. Change in liver biopsy examinations according to conventional Ludwig system.

    Time frame: Week 48

    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.

  2. GLOBE risk scores at week 48.

    Time frame: 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.

  3. Change in liver stiffness status measured by magnetic resonance elastography.

    Time frame: Week 48

    The change of liver stiffness status at the end of the study compared to baseline checked by magnetic resonance elastography.

  4. Change in serum levels of ALP compared to the baseline.

    Time frame: Weeks 0, 4, 8, 12, 24, and 48

    Absolute change in serum levels of ALP compared to the baseline.

  5. Change in serum levels of bilirubin compared to the baseline.

    Time frame: Weeks 0, 4, 8, 12, 24, and 48

    Absolute change in serum levels of bilirubin compared to the baseline.

  6. Change in serum levels of transaminase compared to the baseline.

    Time frame: Weeks 0, 4, 8, 12, 24, and 48

    Absolute change in serum levels of transaminase compared to the baseline.

Other outcomes

  1. Change in pruritus.

    Time frame: Weeks 48

    The symptom of pruritus will be evaluated by questionnaire before enrolment and at the end of the study.

  2. Change in fatigue.

    Time frame: Weeks 48

    The symptom of fatigue will be evaluated by Fatigue Impact Scale before enrolment and at the end of the study.

  3. Change in serum Immunoglobulin M Levels.

    Time frame: Week 48

    Absolute change in serum levels of Immunoglobulin M compared to the baseline.

Sponsors and collaborators

Lead sponsor

Xijing Hospital of Digestive Diseases

Other

Registry information

Official study title

Fenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cirrhosis: a Randomized Control Study

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
Jul 6, 2016
Registry last updated
Mar 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.