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About Primary Biliary Cholangitis

Primary Biliary Cholangitis (PBC) is an autoimmune disease in which the bile ducts are inflamed and slowly destroyed. Bile is a fluid made in the liver, and it helps with digestion and absorbing certain vitamins. Bile also helps the body absorb fats and get rid of cholesterol, toxins and worn-out red blood cells. Ongoing inflammation in the liver can lead to bile duct inflammation and damage known as cholangitis. At times, this can lead to permanent scarring of liver tissue, called cirrhosis which can eventually lead to liver failure. If you want to help PBC research, participation in a study may be right for you. Learn more about the currently enrolling study below and complete the pre-screener today.

About the Study

The AFFIRM clinical trial is looking for people with PBC and compensated cirrhosis to participate. Patients who qualify after screening will be randomly placed into treatment groups where the patient and the principal investigator do not know who gets assigned the study medication. The study will be looking at how well the study drug helps patients compared to a placebo. It is also looking at whether people in the trial have side effects and which ones. If enrolled in the study, participants will receive an oral investigational medication or its matching placebo once daily for a period of 3 years and will be asked to attend up to approximately 18 doctor’s visits. Participants will receive trial-related procedures and study medication at no cost.

Eligibility Requirements

Participants must be:

Ages

18 years and older

Diagnosed

Diagnosed with Primary Biliary
Cholangitis and Liver Cirrhosis

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If you have been diagnosed with PBC, you may qualify for a clinical trial.

Advancing Research

By participating in a study, you can impact others facing similar conditions today and in the future.

Reimbursement for time & travel

Financial compensation varies by study, you can earn compensation for study related time and travel.

No-cost study-related medical care

Participants could receive access to the investigational treatment and study medical care.

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What to Expect

  • Step 1

    Prescreening

  • Step 2

    Study Enrollment

  • Step 3

    Trial Participation

The first step towards enrollment is to see if you pre-qualify for this study. If your medical condition and symptoms match the study criteria, you will be contacted by a study coordinator for further evaluation. If you do not qualify for this specific trial, you can submit your contact information and we will contact you if you match to new trials in the future.

After pre-qualification, the next step is to have an in-person appointment at a local study site to enroll in the research study. Study sites are medical facilities (like hospitals, clinics and universities) where study-related activities will occur. At your first visit, you will receive additional information about the trial. You may be required to complete further screening at the study site to confirm your eligibility.

Before fully enrolling in the study, participants will read and sign an informed consent document that gives a full explanation of all activities that will happen during the study. This consent document is not a contract, and participants can withdraw their consent from the study at any time.

If enrolled, you have a 66% chance (or 2 in 3 chances) of receiving study drug and a 33% chance of receiving placebo. Study procedures include physical examinations, vital signs, laboratory tests and liver biopsies. Participants will receive trial-related procedures and study medication at no cost. Travel costs may be reimbursed.

To Get Started, Take the Private Online Pre-screener Questionnaire

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Frequently Asked Questions

Who is sponsoring this trial?

Gilead Sciences is conducting the AFFIRM clinical trial. Gilead Sciences is a global biopharmaceutical company that is headquartered in Foster City, California.

Will I receive the investigational medication/study drug if I participate in this trial?

You will have a 66% chance (or 2 in 3 chance) of getting assigned to the study drug and a 33% chance of being assigned to the placebo group.

Will I receive a placebo if I participate in this trial?

You will have a 33% chance of being assigned to the placebo group.

Will I have health checks?

You may have up to 18 office doctor’s visits with various assessments such as, physical examinations, vital signs, laboratory tests, and liver biopsies if applicable.

Why should I join this study?

If you are living with a medical condition, joining a clinical trial can help researchers understand how this investigational 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. Volunteers in trials contribute to this medical progress as well by helping understand the effect of the investigational treatment and any safety concerns.

If I participate, can I continue my current medications?

Participants will be allowed to stay on their current PBC background medication. If you are currently taking immunosuppressant therapies (Sirolimus, Cyclosporine or Methotrexate), systemic steroids such as (Prednisone (> 5mg/day), fibrates (cholesterol lowering medication), or Obeticholic Acid (OCA), you will be excluded from the study. Any other medication use can be discussed with the study doctor.

What phase of the trial is being conducted?

This trial is a Phase 3 clinical trial.

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