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Fibrate
Obeticholic Acid + Bezafibrate for Primary Biliary Cholangitis
Phase 2
Waitlist Available
Research Sponsored by Intercept Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
A definite or probable diagnosis of PBC
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and at weeks 2, 4, 6, 8, 10 and 12
Awards & highlights
Study Summary
This trial will test the effect of bezafibrate and obeticholic acid on patients with primary biliary cholangitis.
Who is the study for?
This trial is for people with Primary Biliary Cholangitis (PBC) who have been on a drug called UDCA for at least a year, or not at all in the past 3 months. It's not open to pregnant or breastfeeding women, those who can't handle bezafibrate, have other liver diseases, gallbladder disease, or were recently in fibrate/OCA studies.Check my eligibility
What is being tested?
The study tests bezafibrate (BZF), alone and combined with obeticholic acid (OCA), against placebos to see their effects on PBC. Participants will receive either BZF at different doses or OCA along with dummy pills to compare results.See study design
What are the potential side effects?
Possible side effects include digestive issues like stomach pain and constipation, itching skin due to increased bile acids if there's blockage of bile flow, muscle pain from statin-like effects of fibrates, and potential liver function changes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with primary biliary cholangitis.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and at weeks 2, 4, 6, 8, 10 and 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and at weeks 2, 4, 6, 8, 10 and 12
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Alkaline Phosphatase (ALP) from Baseline to Week 12
Secondary outcome measures
Change from Baseline in biochemical disease marker ALT
Change from Baseline in biochemical disease marker AST
Change from Baseline in biochemical disease marker GGT
+6 moreTrial Design
5Treatment groups
Experimental Treatment
Active Control
Group I: Long Term Safety Extension (LTSE) Phase Treatment D of the DB phase: OCA 5 mg + BZF 400 mg IRExperimental Treatment2 Interventions
Each participant will take one OCA 5 mg tablet and two BZF 200 mg IR tablets (to achieve 400 mg dose) daily.
Group II: Double Blind (DB) Phase Treatment D: OCA 5 mg + BZF 400 mg IRExperimental Treatment2 Interventions
Each participant will take one OCA 5 mg tablet and two BZF 200 mg IR tablets (to achieve 400 mg dose) daily.
Group III: Double Blind (DB) Phase Treatment C: OCA 5 mg + BZF 100 mg IRExperimental Treatment3 Interventions
Each participant will take one OCA 5 mg tablet, one BZF 100 mg IR tablet and one BZF placebo tablet, daily.
Group IV: Double Blind (DB) Phase Treatment A: BZF 100 milligrams (mg) Immediate Release (IR) tabletActive Control3 Interventions
Each Participant will take one OCA placebo tablet, one BZF 100 mg IR tablet and one BZF placebo tablet daily.
Group V: Double Blind (DB) Phase Treatment B: BZF 400 mg IR tabletActive Control2 Interventions
Each Participant will take one OCA placebo tablet and two BZF 200 mg IR tablets (to achieve 400 mg dose) daily.
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Who is running the clinical trial?
Intercept PharmaceuticalsLead Sponsor
27 Previous Clinical Trials
16,790 Total Patients Enrolled
George Harb, M.D.Study DirectorIntercept Pharmaceuticals, Inc
2 Previous Clinical Trials
94 Total Patients Enrolled
Lynda Szczech, M.D.Study DirectorIntercept Pharmaceuticals, Inc
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot tolerate fibrates or have not taken them in the last 3 months.I have been diagnosed with primary biliary cholangitis.I haven't taken OCA or similar drugs in the last 3 months.I have or had gallbladder disease.I am experiencing complications from primary biliary cholangitis.I have or had other liver diseases besides my current condition.I am currently pregnant or breastfeeding.I have been on UDCA for 12 months or haven't taken it for 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: Long Term Safety Extension (LTSE) Phase Treatment D of the DB phase: OCA 5 mg + BZF 400 mg IR
- Group 2: Double Blind (DB) Phase Treatment D: OCA 5 mg + BZF 400 mg IR
- Group 3: Double Blind (DB) Phase Treatment A: BZF 100 milligrams (mg) Immediate Release (IR) tablet
- Group 4: Double Blind (DB) Phase Treatment B: BZF 400 mg IR tablet
- Group 5: Double Blind (DB) Phase Treatment C: OCA 5 mg + BZF 100 mg IR
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are being enrolled in this research project?
"Affirmative. The clinical trial registry, which was first published on March 21st 2022, is actively recruiting for volunteers. There are a total of 25 sites accepting 60 enrollees in this study."
Answered by AI
Has Bezafibrate 200 MG received sanctioning from the FDA?
"Our assessment at Power gave Bezafibrate 200 MG a score of 2 due to the fact that it is currently in Phase 2 clinical trials, meaning there are some safety data available but no efficacy data has been reported yet."
Answered by AI
How many healthcare facilities are actively conducting this research project?
"25 medical facilities are currently enrolling patients for this clinical trial. The sites span from Naples to Miami and Dothan, with many other locations in between - make sure you choose the closest one so that your travel is kept to a minimum."
Answered by AI
Are there any vacancies available for individuals to partake in this investigation?
"Affirmative. The trial hosted on clinicaltrials.gov has been actively recruiting since March 21st 2022, and the requirements were last modified on August 24th of that same year. This medical investigation is looking for 60 subjects from 25 diverse sites."
Answered by AI
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