NCT02823353

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
117

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Apr 2016

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

April 8, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 6, 2016

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 6, 2022

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

March 8, 2023

Status Verified

September 1, 2022

Enrollment Period

6.1 years

First QC Date

January 28, 2016

Last Update Submit

March 6, 2023

Conditions

Primary Biliary Cirrhosis

Keywords

PBCUDCAFenofibrate

Outcome Measures

Primary Outcomes (1)

  • Rate of patients with complete biochemical response

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

    Week 48

Secondary Outcomes (6)

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

    Week 48

  • GLOBE risk scores at week 48.

    Week 48

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

    Week 48

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

    Weeks 0, 4, 8, 12, 24, and 48

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

    Weeks 0, 4, 8, 12, 24, and 48

  • +1 more secondary outcomes

Other Outcomes (3)

  • Change in pruritus.

    Weeks 48

  • Change in fatigue.

    Weeks 48

  • Change in serum Immunoglobulin M Levels.

    Week 48

Study Arms (2)

Fenofibrate + UDCA

EXPERIMENTAL

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

Drug: FenofibrateDrug: UDCA

Monotherapy

ACTIVE COMPARATOR

UDCA 13-15mg/kg/day

Drug: UDCA

Interventions

FenofibrateDRUG

Fenofibrate 200mg/day

Fenofibrate + UDCA
UDCADRUG

UDCA 13-15mg/kg/day

Fenofibrate + UDCAMonotherapy

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xijing Hosipital

Xi'an, Shaanxi, 710032, China

Location

Related Publications (1)

  • Liu Y, Guo G, Zheng L, Sun R, Wang X, Deng J, Jia G, Yang C, Cui L, Guo C, Shang Y, Han Y. Effectiveness of Fenofibrate in Treatment-Naive Patients With Primary Biliary Cholangitis: A Randomized Clinical Trial. Am J Gastroenterol. 2023 Nov 1;118(11):1973-1979. doi: 10.14309/ajg.0000000000002238. Epub 2023 Mar 9.

    PMID: 36892506DERIVED

MeSH Terms

Conditions

Liver Cirrhosis, Biliary

Interventions

Fenofibrate

Condition Hierarchy (Ancestors)

Cholestasis, IntrahepaticCholestasisBile Duct DiseasesBiliary Tract DiseasesDigestive System DiseasesLiver DiseasesLiver CirrhosisFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fibric AcidsIsobutyratesButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsPhenyl EthersEthersBenzophenonesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPhenolsKetones

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Consultant Physician

Study Record Dates

First Submitted

January 28, 2016

First Posted

July 6, 2016

Study Start

April 8, 2016

Primary Completion

May 6, 2022

Study Completion

June 1, 2022

Last Updated

March 8, 2023

Record last verified: 2022-09

Locations

CN(1)