A 52-week, placebo-controlled, randomized, Phase 3 study to evaluate the safety and efficacy of seladelpar in subjects with primary biliary cholangitis (PBC) and an inadequate response to or an intolerance to ursodeoxycholic acid (UDCA)
Study of seladelpar in subjects with primary biliary cholangitis (PBC)
Sponsor: CymaBay Therapeutics, Inc.
Enrolling: Male and Female Patients
IRB Number: AAAS1003
U.S. Govt. ID: NCT03602560
Contact: Christina Falo, PhD: 212-305-3839 / cf2427@cumc.columbia.edu
Additional Study Information: If you have primary biliary cholangitis (PBC), previously referred to as primary biliary cirrhosis, you may qualify for a clinical research study. In this study, doctors are trying to learn more about the effectiveness and safety of an investigational drug called seladelpar for patients with PBC. The ENHANCE clinical research study is enrolling patients who have tried using ursodeoxycholic acid (UDCA or ursodiol) and didn't have adequate results or are unable to tolerate this treatment. There is a 1 in 3 chance you will receive placebo in this study. Placebo is an inactive substance that looks like the investigational drug. During the study, you will not know if you are receiving placebo or seladelpar. If you qualify during the screening period and you want to participate, you'll receive the study drug or placebo to take orally (by mouth) 1 time each day for 52 weeks. After the first 6 months, your dose may change if you are not responding well. During the study (a total of about 60 weeks), you will have approximately 9 visits to the study doctors office, and 3 phone/email remote visits. You may also have a follow-up visit after you leave the study. After participation in this study, you may be eligible to participate in a long-term study of seladelpar.
This study is closed
Elizabeth Verna, MD
Do You Qualify?
Are you 18-75 years old? Yes No
Have you been diagnosed with primary biliary cholangitis (PBC)? Yes No
You may be eligible for this study

Place Holder

For more information, please contact:
Christina Falo, PhD