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JOIN A CLINICAL TRIAL FOCUSED ON PRIMARY BILIARY CHOLANGITIS WITH COMPENSATED CIRRHOSIS
Consider joining a clinical trial that's investigating a drug for people with primary biliary cholangitis (PBC) and compensated cirrhosis. Even if you're currently on UDCA therapy, you can still take part in the trial without interrupting your regimen. Your participation could contribute to much-needed advancements in understanding and treating this disease in people with cirrhosis.
ABOUT THE AFFIRM PBC CLINICAL TRIAL
The AFFIRM clinical trial is a randomized, double-blind, placebo-controlled trial for people with PBC and compensated cirrhosis. It is looking at how well seladelpar helps patients compared to a placebo. It is also looking at whether people in the trial have side effects, and which ones.
The findings of the AFFIRM clinical trial will contribute to the research being done with seladelpar. By joining this clinical trial, you could help contribute to this important research for people with PBC and compensated cirrhosis.
WHY PARTICIPATE?
If you qualify and decide to join, you will receive the following at no cost:
- Expert medical care from the study team during the trial for your PBC with compensated cirrhosis
- A 66% chance of receiving seladelpar
- The opportunity to be a critical part of researching the future of seladelpar
All participants will be allowed to stay on their current background medication
Qualifying participants could receive compensation for time, travel, and other trial-related expenses.
DO I QUALIFY?
To be eligible for the trial, you must meet the following criteria:
Frequently asked questions
About AFFIRM
What is the time commitment?
The trial will last about 3 years. Initially, the check-ins will be more frequent. There is a 5-week screening period. Once you qualify and enroll in the trial, check-ins will be every 2-4 weeks for the first 3 months. After that, each check-in will be about 3 months apart. During the consent process before enrolling, the research team will explain the check-ins and answer any remaining questions you may have about the time commitment that would be required.
Where will I go to participate in AFFIRM?
AFFIRM will be conducted at approximately 200 sites around the world. When you take the pre-screener, we will use your zip code to locate a trial site in your area.
What if I don’t qualify to participate?
If you don’t qualify due to not meeting the trial criteria, you should check with your healthcare provider to seek other options.
How is my personal information protected?
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.
Who is the clinical trial sponsor?
Gilead Sciences is conducting the AFFIRM clinical trial. Gilead Sciences is a global biopharmaceutical company that is headquartered in Foster City, California.
Can I withdraw from AFFIRM?
Yes, participants are volunteers and may withdraw from a clinical trial at any time.
What does it mean if I provide “informed consent”?
Your informed consent is required before being enrolled in AFFIRM. 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 and consent to participate in the trial. Informed consent is designed to protect your safety and privacy.
Am I allowed to visit my usual healthcare provider when enrolled in AFFIRM?
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.
Who is on the clinical trial team?
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.
About Clinical Trials
What is a clinical trial?
Clinical trials answer questions about how well a study drug works and/or how safe it is by monitoring its effect on people (often through bloodwork and other tests, as well as checking for symptoms and side effects). The people in clinical trials are called clinical trial participants and are volunteers who may be healthy or have a specific illness or condition.
Why do we need clinical trials?
Clinical trials are used to determine if the study drug is safe and works as expected in people. The products being studied in a clinical trial can be a drug, vaccine, medical device, medical procedure, and/or behavioral intervention. Before any drug can be used by the general public, they must undergo a series of clinical trials, called phases, and be approved by regulatory agencies (such as the FDA in the United States and the European Medicines Agency [EMA] in Europe).
Are clinical trials covered by insurance in the United States?
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.
Do participants learn the results of their clinical trial?
After your participation ends, the trial 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.
WHAT IS PBC WITH COMPENSATED CIRRHOSIS?
Primary biliary cholangitis (PBC) is a chronic liver disease that can lead to cirrhosis, or widespread scarring of the liver. In cases of compensated cirrhosis, the liver, despite the damage, can still function.
PBC often occurs gradually and primarily affects women and people who are middle aged.1,2
References: 1. Kumar R, Kumar S, Prakash SS. Compensated liver cirrhosis: natural course and disease-modifying strategies. World J Methodol. 2023;13(4):179-193. 2. National Institute of Diabetes and Digestive and Kidney Diseases. Primary Biliary Cholangitis. Definition & facts of primary biliary cholangitis (primary biliary cirrhosis). National Institutes of Health; 2015. Updated March 2021. Accessed October 16, 2024. https://www.niddk.nih.gov/health-information/liver-disease/primary-biliary-cholangitis/definition-facts