Not recruitingRare disease

Study on the Long-Term Safety of Obeticholic Acid and Bezafibrate for Patients with Primary Biliary Cholangitis

Verified siteInvestigationalNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying Primary Biliary Cholangitis (PBC), a chronic disease that affects the liver. The study is evaluating a treatment that combines two medications: Obeticholic Acid and Bezafibrate. These medications are taken together in a single tablet form, known as OCA/BZF FDC, which stands for Fixed-Dose Combination of Obeticholic Acid and Bezafibrate.

The purpose of the study is to assess the long-term safety and tolerability of this combination treatment in individuals with PBC. Participants in the study will take the medication over an extended period, and researchers will monitor various health markers to ensure the treatment is safe and well-tolerated. These markers include levels of certain enzymes and substances in the blood that indicate liver function and bile acid balance.

The study is designed to provide valuable information about how well the treatment works over time and its impact on the health of individuals with PBC. Participants will be observed for changes in their condition, and the study will help determine if the treatment can effectively manage the symptoms and progression of PBC. The trial is open-label, meaning both the researchers and participants know which treatment is being administered, and it is a long-term study to gather comprehensive safety data.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Introduction to the study
The study is designed to evaluate the long-term safety and tolerability of a fixed-dose combination tablet containing obeticholic acid and bezafibrate for individuals with primary biliary cholangitis (PBC).
Participants must have previously been involved in Study 747-213 or Study 747-214 and be actively taking the investigational product.
Step 2
Medication administration
The medication is administered orally in the form of a tablet.
Each tablet contains 5 mg of obeticholic acid and 400 mg of bezafibrate in a sustained-release (SR) formulation.
The frequency and duration of administration will be determined by the study protocol.
Step 3
Monitoring and assessments
Regular monitoring of biochemical disease markers will be conducted. These include ALP (alkaline phosphatase), GGT (gamma-glutamyl transferase), ALT (alanine aminotransferase), AST (aspartate aminotransferase), and bilirubin levels.
Biomarkers of bile acid synthesis and homeostasis, such as 7α-hydroxy-4-cholesten-3-one (C4) and bile acids, will also be assessed.
Step 4
Evaluation of primary endpoints
The primary endpoints focus on the response rates of reduction from baseline and normalization rates of ALP, GGT, ALT, AST, and bilirubin levels.
Changes from baseline in these markers will be evaluated to determine the effectiveness of the treatment.
Step 5
Evaluation of secondary endpoints
Secondary endpoints include changes from baseline in non-invasive markers of liver fibrosis and other health-related quality of life measures.
The study will also track the percentage of participants achieving specific biochemical targets and the time to first occurrence of significant clinical events such as death, liver transplant, or hospitalization.
Step 6
Study duration
The study is expected to continue until November 25, 2029.
Participants will be involved in the study for the duration specified in the protocol, with regular follow-ups and assessments as outlined.

Who can join the trial?

5 criteria

The study is for people with **Primary Biliary Cholangitis (PBC)**, a liver condition.
Participants must have been part of Study 747-213 or Study 747-214 and are currently taking the study medication.
Both **men and women** can participate.
Participants must be within the specified age range, which includes adults and older adults.
The study includes individuals who may be considered part of a **vulnerable population**. This term refers to groups who might need special protection or care.

Who cannot join the trial?

10 criteria

Patients who have a different liver condition other than Primary Biliary Cholangitis (PBC) cannot participate. PBC is a disease that affects the bile ducts in the liver.
Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
Patients who are not able to follow the study procedures or take the study medication as required cannot participate.
Patients who have any other serious health conditions that might interfere with the study cannot participate.
Patients who are pregnant or breastfeeding cannot participate in the study.
Patients who have a history of allergic reactions to the study medication or similar medications cannot participate.
Patients who are currently participating in another clinical trial cannot participate in this study.
Patients who have a history of substance abuse or alcohol abuse cannot participate.
Patients who have had a liver transplant cannot participate in the study.
Patients who have certain abnormal blood test results that indicate severe liver damage cannot participate.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Amsterdam UMC
Responsive
Amsterdam, The Netherlands
Katholieke Universiteit te Leuven
Responsive
Leuven, Belgium
Vilniaus universiteto ligonine Santaros klinikos VšĮ
Responsive
Vilnius, Lithuania

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Investigated drugs

Obeticholic Acid is a medication used to treat a liver condition known as primary biliary cholangitis. It works by reducing the production of bile acids in the liver, which can help decrease liver damage and improve liver function. Bezafibrate is another medication used in the treatment of primary biliary cholangitis. It helps to lower certain fats in the blood and can improve liver function by reducing inflammation and bile acid levels. In this clinical trial, these two medications are combined into a single tablet to evaluate their long-term safety and effectiveness when used together for treating primary biliary cholangitis.

What is already known about the treatment

Obeticholic Acid
This medication is administered orally in tablet form and is currently being studied in combination with Bezafibrate for its long-term safety and tolerability in treating Primary Biliary Cholangitis (PBC). Obeticholic Acid is a bile acid analog that works by activating the farnesoid X receptor (FXR), which plays a role in regulating bile acid synthesis and transport. It is classified as a farnesoid X receptor agonist and is primarily used to improve liver function in patients with PBC.
Bezafibrate
This medication is also administered orally in tablet form and is being evaluated in combination with Obeticholic Acid for its safety and effectiveness in treating Primary Biliary Cholangitis (PBC). Bezafibrate is a fibrate that works by activating peroxisome proliferator-activated receptors (PPARs), which help regulate lipid metabolism and reduce inflammation. It is classified as a lipid-lowering agent and is used to manage cholesterol levels and improve liver function in PBC patients.

Investigated diseases

Primary Biliary Cholangitis – Primary Biliary Cholangitis (PBC) is a chronic disease that affects the liver. It occurs when the bile ducts in the liver become damaged, leading to a buildup of bile. This buildup can cause inflammation and scarring of the liver tissue over time. As the disease progresses, it can lead to liver dysfunction. Symptoms may include fatigue, itchy skin, and yellowing of the skin and eyes. The exact cause of PBC is not well understood, but it is believed to involve an autoimmune response.