RecruitingPHASE3INTERVENTIONAL

Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis

This research study is investigating a new medication called Seladelpar for adults who have a liver condition known as Primary Biliary Cholangitis (PBC) and some mild scarring of their liver, called compensated cirrhosis. PBC is a long-term disease that slowly damages the small bile ducts in the liver and can lead to liver scarring. This study is in its final main stage (Phase 3). Its main goal is to find out if Seladelpar can lead to better health for people with this condition and if it's safe to use. Some participants will receive Seladelpar, and others will receive a placebo (a dummy pill with no active medicine) to see how effective the new drug is.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Gilead Sciences

Enrolment target

318

Start

07 Sep 2023

Estimated completion

01 Aug 2030

Primary Biliary Cholangitis

What is this study about?

This study is about a condition called Primary Biliary Cholangitis, or PBC. PBC is a long-term liver disease that slowly damages the small tubes in your liver that carry bile, a fluid that helps with digestion. Over time, this damage can lead to scarring of the liver, which is called cirrhosis. In this study, we are focusing on people with PBC who also have a mild form of cirrhosis, known as compensated cirrhosis, meaning their liver is still generally working well.

The researchers want to see if a new medicine called Seladelpar can help improve the health of people with PBC and compensated cirrhosis. They will compare Seladelpar with a 'placebo', which is a dummy pill that looks like the study drug but contains no active medicine. This helps them understand if any changes seen in people taking Seladelpar are truly due to the drug and not just other factors.

Finding new and effective treatments for PBC is very important because it can help improve the quality of life and long-term health for those living with the condition. This study is in its final phase (Phase 3), which means it's a large study designed to confirm how well the medicine works and if it's safe before it can be considered for wider use.

Key takeaways

This study is testing a new medicine called Seladelpar for PBC.
It's for adults who also have mild liver scarring (compensated cirrhosis).
You might receive Seladelpar or a dummy pill (placebo).
Participation involves regular clinic visits for checks and blood tests.
The study aims to see if Seladelpar improves health outcomes for PBC.
You can stop participating at any time.

Who may be eligible?

To join this study, you must be 18 years old or older and have a confirmed diagnosis of Primary Biliary Cholangitis (PBC). You also need to have some mild liver scarring (cirrhosis) that is not severe, as determined by the study doctors. It's important that you haven't taken Seladelpar before.

There are also some reasons why you might not be able to join. For example, if you've already had a liver transplant or are on a list for one, or if your liver disease is very severe, you wouldn't be able to take part. Also, if you have other serious medical conditions that the doctor thinks would prevent you from safely participating, or recent severe liver-related problems, you would not be eligible.

For women who could become pregnant and men who could father a child, specific contraception methods must be used during the study and for a period afterwards to prevent pregnancy.

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?
Do you have a diagnosis of Primary Biliary Cholangitis (PBC)?
Has a doctor told you that you have mild liver scarring (compensated cirrhosis)?
Have you *never* taken any medicine called Seladelpar before?
Are you willing and able to use specific birth control methods if applicable?
Have you *not* had a liver transplant or are currently waiting for one?

Answer every question to see your result.

What does participation involve?

If you join this study, you’ll be given an investigational medication, either Seladelpar or a placebo, to take regularly. You will have a number of visits to the study clinic where doctors and nurses will check your health. This will involve physical examinations, blood tests, and possibly other tests to monitor your liver function and overall well-being. These checks are important to see how the medication is affecting you and to ensure your safety.

The total duration of your participation in the study will involve regular follow-up appointments over a period of time, which the study team will explain in detail. You will need to carefully follow instructions on how to take the study medicine and come to all your scheduled appointments. The study team will provide all the necessary information and support throughout your involvement.

Potential risks and benefits

Participating in this study might offer potential benefits, such as receiving a new investigational medication that could improve your PBC condition. You will also receive very close medical monitoring of your liver health. However, there are potential risks, as Seladelpar is an experimental drug, and side effects are possible, though they will be closely monitored. There's also the chance you might receive the placebo and not the active drug. It’s important to remember that you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (199)

University of Alabama at Birmingham
Verified postcode
Birmingham, United States· Recruiting
St. Joseph's Hospital and Medical Center - 350 W. Thomas
Verified postcode
Phoenix, United States· Recruiting
OM Research LLC
Verified postcode
Lancaster, United States· Recruiting
SCPMG/Kaiser Permanente Los Angeles Medical Center
Verified postcode
Los Angeles, United States· Recruiting
Cedar Sinai Medical Center
Verified postcode
Los Angeles, United States· Recruiting
California Liver Research Institute
Verified postcode
Pasadena, United States· Recruiting
Stanford University
Verified postcode
Redwood City, United States· Recruiting
University of California, Davis Medical Center
Verified postcode
Sacramento, United States· Recruiting
California Pacific Medical Center - Sutter Pacific Medical Foundation
Verified postcode
San Francisco, United States· Recruiting
Connie Frank Transplant Center at UCSF
Verified postcode
San Francisco, United States· Recruiting
Covenant Metabolic Specialists, LLC
Verified postcode
Fort Myers, United States· Recruiting
Schiff Center for Liver Diseases/University of Miami
Verified postcode
Miami, United States· Recruiting

Common questions

What is Primary Biliary Cholangitis (PBC)?

PBC is a long-term liver condition where the small tubes in your liver that carry bile become damaged, which can lead to scarring over time.

What does 'compensated cirrhosis' mean?

Compensated cirrhosis means you have some scarring of your liver, but your liver is still working well enough to carry out its important jobs.

What is Seladelpar?

Seladelpar is a new medicine being tested in this study to see if it can help people with PBC.

Will I definitely get the new medicine?

No, this study compares Seladelpar with a dummy pill (placebo). There's a chance you might receive the placebo instead of the active medicine.

What is a 'Phase 3' study?

A Phase 3 study is one of the final stages of testing a new medicine. It involves a larger number of patients and aims to confirm the medicine's effectiveness and safety before it can be widely used.

How to find out more

Gilead Clinical Study Information Center

gileadclinicaltrials@gilead.com 1-833-445-3230 (GILEAD-0) Official trial record

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