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Research to Redefine Care for Primary Biliary Cholangitis (PBC)

At Gilead, we are committed to conducting clinical trials that support the fight against PBC. Our dedicated teams are working to push the boundaries of what is possible and investing resources into clinical research that could change the lives of those affected by this condition.

In the US, approximately

PBC clinical trials currently recruiting patients

STATUS Recruiting

AFFIRM

A phase 3/4 clinical trial evaluating if seladelpar is safe to take and works as it should in adults with PBC and compensated cirrhosis.
STATUS Recruiting

IDEAL

A phase 3/4 clinical trial evaluating if seladelpar is safe to take and works as it should in adults with PBC who have an incomplete response or intolerance to ursodeoxycholic acid (UDCA).

Nearly a decade of PBC clinical research with seladelpar


*The original ASSURE long-term safety study was stopped early and then re-started in 2021. Source: Kamata S et al, 2023
†Still recruiting.

About Primary Biliary Cholangitis (PBC)

What is PBC?

PBC is a chronic liver disease that occurs when the small bile ducts in the liver get inflamed and then eventually destroyed. This leads to bile build-up, causing liver damage, scarring, and potentially liver failure. PBC is an autoimmune disease where the body’s immune system mistakenly attacks healthy bile duct cells.

Sources: National Institute of Diabetes and Digestive and Kidney Diseases, Merckmanuals.com

Who’s at risk for PBC?

Who’s at risk for PBC?

While PBC can affect anyone at any time, it’s more common in:

  • Women
  • People between 35 to 60 years old
  • People who are white
  • People who have a family member (especially a sibling) with PBC
Sources: Liverfoundation.org, National Institute of Diabetes and Digestive and Kidney Diseases

PBC diagnosis

PBC often goes unnoticed as many people have no symptoms. It’s typically discovered due to abnormal results in routine liver blood tests.

Blood tests

  • Alkaline phosphatase (ALP) levels: Individuals with PBC usually have high ALP levels in the blood, which might be liver damage
  • Antimitochondrial antibodies (AMA): The presence of AMAs in the blood is positive in most PBC cases
Sources: Liverfoundation.org, National Institute of Diabetes and Digestive and Kidney Diseases

PBC symptoms

  • Early and most common symptoms: Itching and feeling tired
  • Less frequent symptoms: Stomach pain, joint pain, or dry mouth and eyes
  • Later stage symptoms: Darkening or yellowing of the skin, small yellow bumps on the skin, swelling of the legs and feet, or an enlarged stomach
Sources: Liverfoundation.org, National Institute of Diabetes and Digestive and Kidney Diseases

Your Questions Answered

We're working to discover, develop and deliver innovative therapeutics for people with life-threatening diseases.

YOUR QUESTIONS ANSWERED

FAQ Topic:
ALL Clinical Trial Basics Safety and Security Trial Terms Defined The Clinical Trial

We're working to discover, develop and deliver innovative therapeutics for people with life-threatening diseases.

All trials have different timelines due to various factors, such as the trial phase, study design, treatment duration or health condition being studied. During the consent process before enrolling, the research team will explain the specifics about the trial.
Due to the many differences in insurance plans across the country, coverage in clinical trials can vary. You will learn more about your options during pre-screening.
If you are living with a medical condition, joining a clinical trial may give you access to a new potential treatment before it is publicly available. Just as importantly, it can help researchers understand how this potential treatment affects the body and increase their knowledge about the disease and how to treat it. Participation can also play a vital role in helping others who have a similar condition, both now and in the future. Healthy volunteers in trials contribute to this medical progress as well by helping understand the effect of the potential treatment and any safety concerns.
As with all medical records, participant privacy and confidentiality in trials are protected by law. Once consent is signed, you will be given a trial code. Your trial records will not include your name or personal identity but will identify you with a trial code. This code can only be tracked back to you via a code key which is held by the responsible physician. Your name or personal identity will never be disclosed.
Yes, participants are volunteers and may withdraw from a clinical trial at any time.
A placebo is an inactive version of an intervention that is not intended to provide any medical benefit. It is designed to look the same as the active intervention, so the participant and research team do not know it is a placebo. The placebo is used by comparison to confirm any effects of the intervention being studied, if no approved intervention is available.
"Standard of care" is an intervention already approved for a specific health condition that is available publicly. Interventions in a clinical trial are still being tested to ensure safety and effectiveness.
Some clinical trials are designed to be "double blind" so both participants and researchers are unaware of which treatment group participants are assigned to. This prevents bias from affecting clinical trial data.
Your informed consent is required before being enrolled in a trial. This means you have been provided all relevant information about the study design, how you will participate, your right to withdraw at any time, study alternatives, your personal data protection and the associated risks and benefits. Informed consent is designed to protect patient safety and privacy.
Under FDA regulations, an Institutional Review Board (IRB) is a group that has been formally designated to review and monitor research at a hospital or institution involving human participants. In accordance with FDA regulations, an IRB has the authority to approve, require modifications in, or disapprove research.
Participants are always welcome to visit their usual healthcare providers during a trial. Sometimes, it is important for healthcare providers to collaborate with the research team to ensure success.
After your participation ends, the study may continue for months or years. Once final results from all participants are compiled and analyzed, they are often published publicly. Clinical study report (CSR) synopses and plain language summaries (PLSs) may be made available for certain studies. Check with your clinical trial site or send an email to [email protected] to learn more.
There are a wide variety of professionals involved with any clinical trial, all of whom are vital to ensuring safety and success. The principal investigator, or PI, leads the trial and directs the team of doctors, nurses and other healthcare workers. The clinical trial coordinator manages day-to-day activities and is the main contact for participants. Many clinical trials also have an independent Data and Safety Monitoring Board (DSMB) who periodically reviews data to ensure participant safety, and sometimes effectiveness.
If you don’t qualify because you don’t meet the trial criteria, consider discussing other options with your healthcare provider or the patient’s physician would need to submit a managed access request based on the eligibility. Click here to learn more.