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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2016 by Xijing Hospital of Digestive Diseases
Sponsor:
Information provided by (Responsible Party):
Han Ying, Xijing Hospital of Digestive Diseases
ClinicalTrials.gov Identifier:
NCT02823366
First received: January 28, 2016
Last updated: July 5, 2016
Last verified: June 2016
  Purpose
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.

Condition Intervention Phase
Primary Biliary Cirrhosis
Drug: Fenofibrate
Drug: UDCA
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Xijing Hospital of Digestive Diseases:

Primary Outcome Measures:
  • Rate of patients with complete biochemical response [ Time Frame: Week 24 ]
    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. [ 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.

  • Change in GLOBE risk scores after treatment. [ Time Frame: Week 48 ]
    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. [ Time Frame: Week 48 ]
    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. [ Time Frame: Weeks 0, 4, 8, 12, 24, and 48 ]
    Absolute change in serum levels of ALP compared to the baseline.

  • 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.

  • 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 Outcome Measures:
  • Change in symptom-pruritus. [ Time Frame: Week 24 ]
    The symptom of pruritus will be evaluated by questionnaire before enrolment and at the end of the study.

  • Change in symptom-fatigue. [ Time Frame: Week 24 ]
    The symptom of fatigue will be evaluated by Fatigue Impact Scale before enrolment and at the end of the study.

  • Change in serum Immunoglobulin M Levels. [ Time Frame: Week 24 ]
    Absolute change in serum levels of Immunoglobulin M compared to the baseline.


Estimated Enrollment: 200
Study Start Date: January 2016
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fenofibrate + UDCA
Fenofibrate in combination with ursodeoxycholic acid
Drug: Fenofibrate Drug: UDCA
Active Comparator: Monotherapy
UDCA alone
Drug: UDCA

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02823366

Contacts
Contact: Ying Han, Ph.D 86-29-84771539 hanying@fmmu.edu.cn
Contact: Yongquan Shi, Ph.D 86-29-84771515 shiyquan@fmmu.edu.cn

Locations
China, Shaanxi
Xijing Hosipital Recruiting
Xi`an, Shaanxi, China, 710032
Contact: Ying Han, Ph.D    86-29-84771539    hanying@fmmu.edu.cn   
Contact: Yongquan Shi, Ph.D    86-29-84771515    shiyquan@fmmu.edu.cn   
Sponsors and Collaborators
Xijing Hospital of Digestive Diseases
  More Information

Responsible Party: Han Ying, Professor Consultant Physician, Xijing Hospital of Digestive Diseases
ClinicalTrials.gov Identifier: NCT02823366     History of Changes
Other Study ID Numbers: KY20151230-5
Study First Received: January 28, 2016
Last Updated: July 5, 2016

Keywords provided by Xijing Hospital of Digestive Diseases:
PBC
UDCA
Fenofibrate

Additional relevant MeSH terms:
Fibrosis
Liver Cirrhosis
Liver Cirrhosis, Biliary
Pathologic Processes
Liver Diseases
Digestive System Diseases
Cholestasis, Intrahepatic
Cholestasis
Bile Duct Diseases
Biliary Tract Diseases
Ursodeoxycholic Acid
Fenofibrate
Cholagogues and Choleretics
Gastrointestinal Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents

ClinicalTrials.gov processed this record on March 28, 2017