RecruitingOBSERVATIONAL

A Study Observing Everyday Effectiveness and Safety of the Drug Elafibranor in Participants With Primary Biliary Cholangitis Who Are Receiving Ongoing Treatment

This study is gathering information about a medicine called elafibranor for people living with Primary Biliary Cholangitis (PBC). PBC is a rare liver condition where small tubes in the liver become damaged, which can lead to scarring and affect how your liver works. This damage can also cause symptoms like itching and tiredness. The main goal of this study is to see how well elafibranor works, if it's safe, and how people feel while taking it as part of their regular treatment. This is not a study where you are given a new drug for the first time. Instead, it's about understanding the drug's effects when used in the real world. Each person in the study will be followed for about five years to see the long-term effects.

At a glance

Status

Recruiting

Sponsor

Ipsen

Enrolment target

424

Start

14 Oct 2024

Estimated completion

15 Jul 2032

Primary Biliary Cholangitis

What is this study about?

This study is focused on understanding more about a medicine called elafibranor for people who have a liver condition called Primary Biliary Cholangitis, or PBC. PBC is a rare disease where the tiny tubes in your liver that carry bile (a digestive fluid) become damaged. Over time, this damage can lead to scarring, which doctors call cirrhosis. This can cause various symptoms like severe itching and feeling very tired, and in some cases, it can become serious enough to need a liver transplant.

This isn't a trial testing a brand new medicine. Instead, it's about observing how elafibranor works for people who are already taking it, or whose doctor has decided they should start taking it, as part of their regular care. The researchers want to learn if the medicine is helping people feel better, whether it's safe to use over time, and if people can take it without too many unpleasant side effects. By collecting this information, they hope to get a clearer picture of how elafibranor helps people with PBC in day-to-day life.

Each person who takes part in this study will be followed by the research team for about five years. This long-term follow-up is important because it allows the researchers to see the effects of the medicine over a significant period. This information will help doctors understand more about PBC and how best to manage it for patients in the future.

Key takeaways

This study is about learning more about the medicine elafibranor for PBC.
It observes how elafibranor works in everyday life, not as a brand new test.
You must have PBC and either be taking elafibranor or about to start it.
Participants will be followed for about five years.
The goal is to understand how well the drug works, its safety, and how people tolerate it.
Your participation helps improve care for others with PBC in the future.

Who may be eligible?

To join this study, you must have a diagnosis of Primary Biliary Cholangitis (PBC). Your doctor must have decided that you should either start taking elafibranor, or you might already be taking it as part of your regular treatment.

It's really important that you understand what the study involves and are happy to give your written permission to take part. If you have a carer who helps you, and they agree to fill out some questionnaires, they would also need to give their permission.

You cannot join if you are already taking part in another study that involves an investigational drug or medical device. Also, if you know you are allergic to elafibranor or any of its ingredients, you wouldn't be able to participate. Finally, if there's any concern that you might not be able to understand the study information or follow the study plan, you wouldn't be eligible.

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.

Do I have a diagnosis of Primary Biliary Cholangitis (PBC)?
Has my doctor decided for me to start or continue taking elafibranor?
Am I willing to provide written permission and follow the study plan?
Am I allergic to elafibranor or any of its ingredients?
Am I currently taking part in another study with an investigational drug or device?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will be followed by the study team for about five years. During this time, the researchers will collect information about your health and how you feel while you are taking elafibranor as prescribed by your doctor. This will likely involve regular check-ups, which may include reviewing your medical records, discussing any symptoms you're experiencing, and standard tests like blood tests. The study wants to see how the medication affects you in your daily life, so you'll continue your routine care with your doctor. You won't be given any new or extra medicines specially for this study; it's all about observing your current treatment. The researchers will be looking at how well the treatment helps your condition and if you experience any side effects.

Potential risks and benefits

Taking part in this study means contributing to a better understanding of how elafibranor works for people with PBC in the real world. This knowledge could help improve care for others with PBC in the future. As this is an observational study of a treatment you are already taking (or about to start) as part of your normal care, there are unlikely to be many extra risks beyond those associated with your usual medical appointments and taking your medication. Any side effects from the medication would be those you might expect from elafibranor which your doctor will discuss with you. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (68)

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

Southern California Research Center
Verified postcode
Coronado, United States· Recruiting
Cedars-Sinai Medical Center
Verified postcode
Los Angeles, United States· Not yet recruiting
University of California Davis Medical Center
Verified postcode
Sacramento, United States· Recruiting
South Denver Gastroenterology,P.C.
Verified postcode
Englewood, United States· Recruiting
Yale University School of Medicine
Verified postcode
New Haven, United States· Recruiting
Schiff Center for Liver Diseases - University of Miami
Verified postcode
Miami, United States· Recruiting
Beth Israel Deaconess Medical Center, Liver Research Center
Verified postcode
Boston, United States· Recruiting
Virtua Center for Liver Disease - Cherry Hill
Verified postcode
Cherry Hill, United States· Recruiting
Northwell Health Inc, Center for Liver Disease and Transplantation
Verified postcode
Manhasset, United States· Recruiting
UNC Hospitals, The University of North Carolina at Chapel Hill
Verified postcode
Chapel Hill, United States· Recruiting
Cleveland Clinic Foundation
Verified postcode
Cleveland, United States· Recruiting
Medical University of South Carolina (MUSC)
Verified postcode
Charleston, United States· Recruiting

Common questions

What is Primary Biliary Cholangitis (PBC)?

PBC is a rare and progressive liver disease where tiny tubes in the liver that carry bile become damaged, which can lead to scarring.

What is elafibranor?

Elafibranor is a medicine that will be observed in this study for people with PBC. It's not a new drug being tested for the first time.

How long will I be in the study?

Each person in the study will be followed for about five years (60 months).

Do I have to take a new medicine for this study?

No, this study observes people who are already taking elafibranor or whose doctor has decided they should start taking it as part of their regular care.

Can I stop participating if I change my mind?

Yes, you can leave the study at any time for any reason, and it won't affect your medical care.

How to find out more

Ipsen Clinical Study Enquiries

clinical.trials@ipsen.com See e mail Official trial record

Always speak to your GP or specialist before deciding to take part in a study.