Active not recruitingPHASE3INTERVENTIONAL

Study of Seladelpar in Participants With Primary Biliary Cholangitis (PBC)

This research is investigating a medicine called Seladelpar for people with Primary Biliary Cholangitis (PBC). PBC is a liver condition. This particular study is designed to be a long-term look at Seladelpar, mainly to check its safety and how well people tolerate it over an extended period. Researchers also want to see if the medicine continues to work effectively over time and if it helps with common symptoms like itching. Participants in this study will have already taken Seladelpar in a previous clinical trial. The study aims to gather more information to understand the full picture of Seladelpar's benefits and any potential downsides for people living with PBC.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Gilead Sciences

Enrolment target

340

Start

12 Dec 2017

Estimated completion

01 Dec 2028

Primary Biliary Cirrhosis

What is this study about?

This study is all about a medicine called Seladelpar, which is being investigated to treat a liver condition called Primary Biliary Cholangitis, or PBC. PBC affects the bile ducts in your liver, which can lead to damage. The main goal of this particular study is to see how safe Seladelpar is when taken for a long time. It also looks at how well people tolerate the medicine – meaning if they experience any side effects and how manageable those might be over a longer period.

The researchers will also be checking if Seladelpar continues to be effective in treating PBC over the long term. This means they will look at how the medicine impacts the disease itself. Importantly, they will also pay close attention to how participants feel. They'll specifically ask about symptoms like itching, which is a common and often bothersome symptom for people with PBC. By understanding how the medicine affects these symptoms, the study hopes to show how Seladelpar could improve the daily lives of people with PBC.

This study is building on previous research, as all participants will have already taken Seladelpar in another study. This helps the researchers understand the long-term effects better, creating a more complete picture of how Seladelpar could help people with PBC in the future.

Key takeaways

This is a long-term study looking at the safety and effectiveness of Seladelpar for PBC.
Only people who have previously taken Seladelpar in another study can join.
The study will check how participants feel, especially about itching.
Liver health will be a key focus, with regular blood tests.
Participants must be between 18 and 75 years old.
Strict birth control rules apply for men and women who could have children.

Who may be eligible?

To join this study, you must have previously taken part in another study involving Seladelpar for PBC. You also need to be between 18 and 75 years old.

There are some important health requirements. For example, your liver function must be within certain limits, and you cannot have other serious liver conditions like autoimmune hepatitis or primary sclerosing cholangitis. Certain medications, like methotrexate or strong steroids, might mean you can't join.

If you are a woman who could become pregnant, you'll need to use two reliable forms of birth control during the study and for three months after. Men who are sexually active with women who could become pregnant also need to use contraception, and their partners need to do the same. Pregnant or breastfeeding women cannot take part.

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.

I have taken part in a previous Seladelpar study for PBC.
I am between 18 and 75 years old.
My liver function is generally within acceptable limits (as determined by my doctor).
I don't have other serious liver conditions like autoimmune hepatitis.
I am not pregnant or breastfeeding.
I am not taking certain medications like methotrexate or long-term systemic steroids.

Answer every question to see your result.

What does participation involve?

If you join this study, you will continue to take Seladelpar capsules, either 5 mg or 10 mg, as prescribed. Because this is a long-term study, you'll have regular check-ups at the clinic. These appointments will involve blood tests to check your liver health and other body functions, and to see if the medicine is working. You'll also be asked questions about how you are feeling, particularly about any itching you experience, to understand the medicine's effect on your symptoms. The study will monitor your health and how you tolerate the medicine over an extended period, but the total duration of your participation isn't specified here.

Potential risks and benefits

Participating in a study like this could offer potential benefits, such as continued access to Seladelpar, which may help manage your Primary Biliary Cholangitis and its symptoms, particularly itching. You'll also receive close medical attention and monitoring throughout the study. However, there are potential risks, like any medicine, Seladelpar can cause side effects. These will be carefully monitored by the study team. There's also the chance the medicine might not work for you, or it could even worsen your condition, though this is carefully considered by the doctors. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (109)

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

Arkansas Diagnostic Center
Verified postcode
Little Rock, United States
Stanford University School of Medicine
Verified postcode
Palo Alto, United States
California Liver Research Institute
Verified postcode
Pasadena, United States
University of California Davis Medical Center
Verified postcode
Sacramento, United States
California Pacific Medical Center
Verified postcode
San Francisco, United States
University of Colorado - Denver - PPDS
Verified postcode
Aurora, United States
Yale University School of Medicine
Verified postcode
New Haven, United States
Covenant Research Fort Myers
Verified postcode
Fort Myers, United States
Florida Digestive Health Specialist
Verified postcode
Lakewood Rch, United States
University of Miami Miller School of Medicine
Verified postcode
Miami, United States
Covenant Research, LLC
Verified postcode
Sarasota, United States
Digestive Healthcare of Georgia PC
Verified postcode
Atlanta, United States

Common questions

What is Primary Biliary Cholangitis (PBC)?

PBC is a long-term liver disease that slowly damages the small bile ducts in your liver.

What is Seladelpar?

Seladelpar is a medicine being tested to treat PBC.

Do I have to have been in another study to join this one?

Yes, you must have participated in a previous PBC study where you took Seladelpar.

Will I know which dose of Seladelpar I am taking?

This study is 'open-label,' which means you and your doctor will know if you are taking the 5 mg or 10 mg capsule.

What if I get pregnant during the study?

If you are a woman who could get pregnant, you must use specific birth control methods throughout the study, and pregnant women cannot participate.