NCT04751188

Brief Summary

Up to 40% of patients with PBC have an inadequate response to standard treatment with Ursodeoxycholic Acid (UDCA), those patients represent the group in need for additional therapies, having increased risk of disease progression and decreased survival free of liver transplantation. The main objective of the study is to evaluate safety and efficacy of bezafibrate plus ursodesoxicolic acid in patients with PBC and inadequate response to UDCA.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
11

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Oct 2020

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 2, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 5, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 12, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

February 12, 2021

Status Verified

February 1, 2021

Enrollment Period

8 months

First QC Date

February 5, 2021

Last Update Submit

February 9, 2021

Conditions

Primary Biliary Cirrhosis

Keywords

ursodeoxycholic acidBezafibrate

Outcome Measures

Primary Outcomes (1)

  • Biochemical response

    Biochemical response is defined as the reduction of alkaline phosphatase lower than 1.5 times the upper normal limit, reduction of aspartate transaminase lower than 1.5 times the upper normal limit and bilirubin lower than 1 mg/dl.

    6 months

Secondary Outcomes (2)

  • Quality of life

    Baseline and 6 months later

  • Pruritus intensity

    Baseline and 6 months later

Study Arms (2)

Bezafibrate and Ursodeoxycholic acid

EXPERIMENTAL

Bezafibrate 200 mg every 12 hours and ursodeoxycholic acid at a dose of 13 to 15 mg per Kg per day, for 6 months.

Drug: Bezafibrate 200 MG Oral TabletDrug: Ursodeoxycholic Acid

Placebo and Ursodeoxycholic acid

PLACEBO COMPARATOR

Placebo tablet every 12 hours and ursodeoxycholic acid at a dose of 13 to 15 mg per Kg per day, for 6 months.

Drug: PlaceboDrug: Ursodeoxycholic Acid

Interventions

Bezafibrate 200 MG Oral TabletDRUG

Bezafibrate one tablet every 12 hours for six months.

Bezafibrate and Ursodeoxycholic acid
PlaceboDRUG

Placebo one tablet every 12 hours for six months.

Placebo and Ursodeoxycholic acid
Ursodeoxycholic AcidDRUG

At a dose of 13 to 15 mg per Kg per day.

Bezafibrate and Ursodeoxycholic acidPlacebo and Ursodeoxycholic acid

Eligibility Criteria

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

You may qualify if:

  • PBC diagnosis (consistent with American Association for the Study of Liver Disease \[AASLD\]:
  • History of elevated alkaline phosphatase levels.
  • Anti-mitochondrial antibodies positivity
  • Histopathologic evidence of nonsuppurative cholangitis and destruction of small or medium- sized bile ducts.
  • Use of ursodeoxycholic acid (UDCA) for at least 12 months at enrollment at a therapeutic dose (13 to 15 mg per Kg per day).
  • Evidence of a suboptimal biochemical response to UDCA, defined by the presence of one of the Paris II criteria.
  • Written informed consent.
  • Age ≥ 18 years.

You may not qualify if:

  • Hepatic decompensation (ascitis, variceal upper gastrointestinal bleeding, hepatic encephalopathy).
  • Coexistence autoimmune hepatitis.
  • Bilirrubin \>3mg/dl.
  • For females, pregnancy or breast-feeding.
  • Hepatocellular carcinoma.
  • History or presence of spontaneous bacterial peritonitis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Mexicano de Seguro Social

Puebla City, 72000, Mexico

Location

MeSH Terms

Conditions

Liver Cirrhosis, Biliary

Interventions

BezafibrateTabletsUrsodeoxycholic Acid

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

BenzamidesAmidesOrganic ChemicalsFibric AcidsIsobutyratesButyratesAcids, AcyclicCarboxylic AcidsBenzoatesAcids, CarbocyclicChlorobenzoatesPhenyl EthersEthersBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPhenolsDosage FormsPharmaceutical PreparationsDeoxycholic AcidCholic AcidsBile Acids and SaltsSteroidsFused-Ring CompoundsPolycyclic CompoundsCholanes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 5, 2021

First Posted

February 12, 2021

Study Start

October 2, 2020

Primary Completion

June 1, 2021

Study Completion

July 1, 2021

Last Updated

February 12, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

ME(1)