Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A Phase 3, Open-Label, Long-Term Safety Extension Study Evaluating the Safety and Tolerability of the Fixed-Dose Combination of Obeticholic Acid and Bezafibrate in Subjects with Primary Biliary Cholangitis

This ongoing 'Phase 3' study is investigating a new treatment approach for people living with Primary Biliary Cholangitis (PBC). PBC is a disease that slowly damages the bile ducts in the liver. The study is testing a fixed combination of two existing medicines, Obeticholic Acid and Bezafibrate, to see if they can work better together. The main aim is to understand how safe this drug combination is when taken over a longer period. Researchers will also be checking if the treatment helps improve liver function, reduces symptoms, and prevents the disease from getting worse. This is an 'open-label' study, meaning both patients and doctors will know which treatment is being given.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Intercept Pharmaceuticals Inc.

Enrolment target

Start

24 Feb 2025

Primary Biliary Cholangitis (PBC)

What is this study about?

This clinical trial is designed to investigate a new way of treating Primary Biliary Cholangitis (PBC). PBC is a long-term liver disease where the small bile ducts in the liver are slowly destroyed. This can lead to bile building up, causing damage to the liver. The aim of this study is to see if combining two existing medications, Obeticholic Acid and Bezafibrate, into one tablet is a safe and effective way to manage PBC over a long period. Researchers hope this combination could offer a better way to control the disease and improve the health of people with PBC.

The study is in 'Phase 3,' which means it's a large-scale trial happening after earlier tests have shown promising results. The main goal is to closely monitor the safety of this new combination to make sure it's well-tolerated by patients. They will also be looking at several ways to measure how well the treatment is working. This includes checking liver blood tests, like ALP, GGT, ALT, and AST, which tell us how well the liver is functioning. They'll also be looking at other measures of liver health and how patients feel overall.

While the primary focus is on safety and how the treatment affects liver markers, the researchers will also be exploring other important aspects. This includes looking at how the treatment might impact symptoms such as tiredness and itching, and whether it helps prevent complications associated with PBC, like liver scarring or more serious liver problems down the line. By gathering all this information, the study aims to determine if this new drug combination could be a valuable long-term treatment option for people with PBC.

Key takeaways

This study is for adults with Primary Biliary Cholangitis (PBC).
It tests a new combination of two medicines for PBC.
The main goals are to check the safety and long-term effects of the treatment.
Participation involves regular appointments and health monitoring.
You can stop taking part at any time.
It's a 'Phase 3' study, aiming to confirm treatment benefits.

Who may be eligible?

To take part in this study, you must be an adult aged 18 years or older. Both men and women are welcome to participate. The study is specifically for people who have been diagnosed with Primary Biliary Cholangitis (PBC).

There might be other specific health requirements or conditions that would mean you can or cannot join the study. These could include certain blood test results, other medical conditions you might have, or medications you are currently taking. These detailed rules help make sure the study is safe for everyone involved and that the results are clear.

The research team will carefully review your medical history and conduct some tests to confirm if you are a good fit for the study. It's important to discuss any health concerns or medicines you take with them.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you been diagnosed with Primary Biliary Cholangitis (PBC)?
Are you able to attend regular appointments for an extended period?
Are you willing to take the study medication as instructed?
Are you comfortable with regular blood tests and medical check-ups?

Answer every question to see your result.

What does participation involve?

If you decide to participate, you would be taking a new combination medicine that includes Obeticholic Acid and Bezafibrate. Because this is a long-term study, you would likely have regular doctor's visits over an extended period. These visits would involve check-ups, blood tests to monitor your liver health and overall well-being, and potentially other examinations to see how the treatment is affecting you.

The study involves an 'open-label' design, meaning you and your doctor will know you are receiving the combination treatment. The research team will guide you through all the appointments and tests needed. They will monitor your health closely and explain all procedures before they happen. The exact duration of your participation would be discussed, but as a long-term study, it implies ongoing follow-up to track the effects of the treatment over time.

Potential risks and benefits

Participating in a study like this might offer potential benefits, such as receiving a new treatment that could improve your PBC and having your health closely monitored by a team of specialists. However, like all medicines, the study drug combination of Obeticholic Acid and Bezafibrate could have side effects, some of which might be unpleasant or serious. It's also possible the treatment may not work for you. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (12)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Netherlands
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Unverified
France
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Unverified
Norway
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Unverified
Hungary
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Unverified
Italy
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Unverified
Lithuania
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Unverified
Germany
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Unverified
Czechia
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Unverified
Croatia
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Unverified
Estonia
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Unverified
Belgium
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Unverified
Greece

Common questions

What is Primary Biliary Cholangitis (PBC)?

PBC is a long-term liver disease that slowly damages the small tubes in your liver that carry bile, called bile ducts, and can lead to liver damage over time.

What kind of medication is being tested?

The study is testing a fixed combination of two existing medications, Obeticholic Acid and Bezafibrate, in one tablet. These medicines are used to treat liver conditions.

What does 'Phase 3' mean for a clinical trial?

Phase 3 means it's a large study, usually involving many people, which aims to confirm if a new treatment is safe and works better than current options or a placebo, before it can be considered for wider use.

Will I know if I'm getting the study drug?

Yes, this is an 'open-label' study, which means both you and your study doctor will know that you are receiving the combination treatment.

How long would I be in the study?

This is described as a 'long-term' study, meaning your participation would involve ongoing follow-up over an extended period to monitor the effects of the treatment.