Back to resultsA Study to Assess Efficacy and Safety of Bezafibrate in Patients With Primary Biliary Cholangitis
Primary Purpose
Primary Biliary Cirrhosis
Status
Unknown status
Phase
Phase 3
Locations
Mexico
Study Type
Interventional
Intervention
Bezafibrate 200 MG Oral Tablet
Placebo
Ursodeoxycholic Acid
Sponsored by
About this trial
This is an interventional treatment trial for Primary Biliary Cirrhosis focused on measuring ursodeoxycholic acid, Bezafibrate
Eligibility Criteria
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.
Sites / Locations
- Instituto Mexicano de Seguro Social
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Bezafibrate and Ursodeoxycholic acid
Placebo and Ursodeoxycholic acid
Arm Description
Bezafibrate 200 mg every 12 hours and ursodeoxycholic acid at a dose of 13 to 15 mg per Kg per day, for 6 months.
Placebo tablet every 12 hours and ursodeoxycholic acid at a dose of 13 to 15 mg per Kg per day, for 6 months.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Quality of life
Evaluation of quality of life with the Primary Biliary Cholangitis 40 questionnaire
Pruritus intensity
Evaluation made by the use of visual analogue scales.
Full Information
NCT ID
NCT04751188
First Posted
February 5, 2021
Last Updated
February 9, 2021
Sponsor
Instituto Mexicano del Seguro Social
1. Study Identification
Unique Protocol Identification Number
NCT04751188
Brief Title
A Study to Assess Efficacy and Safety of Bezafibrate in Patients With Primary Biliary Cholangitis
Official Title
Safety and Efficacy of Bezafibrate Plus Ursodesoxicolic Acid in Patients With Primary Biliary Cholangitis Without Response
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 2, 2020 (Actual)
Primary Completion Date
June 2021 (Anticipated)
Study Completion Date
July 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Mexicano del Seguro Social
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Biliary Cirrhosis
Keywords
ursodeoxycholic acid, Bezafibrate
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
11 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Bezafibrate and Ursodeoxycholic acid
Arm Type
Experimental
Arm Description
Bezafibrate 200 mg every 12 hours and ursodeoxycholic acid at a dose of 13 to 15 mg per Kg per day, for 6 months.
Arm Title
Placebo and Ursodeoxycholic acid
Arm Type
Placebo Comparator
Arm Description
Placebo tablet every 12 hours and ursodeoxycholic acid at a dose of 13 to 15 mg per Kg per day, for 6 months.
Intervention Type
Drug
Intervention Name(s)
Bezafibrate 200 MG Oral Tablet
Intervention Description
Bezafibrate one tablet every 12 hours for six months.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo one tablet every 12 hours for six months.
Intervention Type
Drug
Intervention Name(s)
Ursodeoxycholic Acid
Intervention Description
At a dose of 13 to 15 mg per Kg per day.
Primary Outcome Measure Information:
Title
Biochemical response
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Quality of life
Description
Evaluation of quality of life with the Primary Biliary Cholangitis 40 questionnaire
Time Frame
Baseline and 6 months later
Title
Pruritus intensity
Description
Evaluation made by the use of visual analogue scales.
Time Frame
Baseline and 6 months later
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Instituto Mexicano de Seguro Social
City
Puebla
ZIP/Postal Code
72000
Country
Mexico
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study to Assess Efficacy and Safety of Bezafibrate in Patients With Primary Biliary Cholangitis
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