A Study to Assess Efficacy and Safety of Bezafibrate in Patients With Primary Biliary Cholangitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-02

Study Completion Date

2021-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Primary Biliary Cirrhosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Bezafibrate and Ursodeoxycholic acid

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

Group Type EXPERIMENTAL

Bezafibrate 200 MG Oral Tablet

Intervention Type DRUG

Bezafibrate one tablet every 12 hours for six months.

Ursodeoxycholic Acid

Intervention Type DRUG

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

Placebo and Ursodeoxycholic acid

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo one tablet every 12 hours for six months.

Ursodeoxycholic Acid

Intervention Type DRUG

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

Interventions

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Bezafibrate 200 MG Oral Tablet

Bezafibrate one tablet every 12 hours for six months.

Intervention Type DRUG

Placebo

Placebo one tablet every 12 hours for six months.

Intervention Type DRUG

Ursodeoxycholic Acid

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No