ASSURE: An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in Subjects with Primary Biliary Cholangitis (PBC)

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Primary Biliary Cholangitis
  • Age: Between 18 - 120 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Participants who can provide written informed consent
    2. Participated in a PBC study with seladelpar (CB8025-21629, CB8025-31735, or CB8025-21838) or future PBC studies with seladelpar that allow rollover into CB8025-31731-RE, or were previously enrolled in study CB8025-31731 prior to the early termination of the study, and meet eligibility criteria for the current study
    3. Females of reproductive potential must use at least one barrier contraceptive and a second effective birth control method during the study and for at least 90 days after the last dose
    4. Male subjects who are sexually active with female partners of reproductive potential must use barrier contraception and their female partners must use a second effective birth control method during the study and for at least 90 days after the last dose

You may not be eligible for this study if the following are true:

    1. Those who had a treatment-related Adverse Event leading to study drug discontinuation in a previous PBC study with seladelpar
    2. A medical condition, other than PBC, that in the Investigator’s opinion would preclude full participation in the study or confound its results
    3. Auto-immune hepatitis
    4. Primary sclerosing cholangitis
    5. Known history of alpha-1-antitrypsin deficiency
    6. Known history of chronic viral hepatitis
    7. For females, pregnancy or breast-feeding
    8. Use of colchicine, methotrexate, azathioprine or long-term use of systemic steroids within 2 months prior to screening
    9. Current use of fibrates or use of fibrates within 3 months prior to Screening
    10. Current use of obeticholic acid or use of obeticholic acid within 3 months prior to Screening
    11. Use of an experimental or unapproved treatment for PBC within 3 months prior to Screening
    12. History of malignancy diagnosed or treated, actively or within 2 years, or active evaluation for malignancy; localized treatment of squamous or non-invasive basal cell skin cancers and cervical carcinoma in-situ is allowed if appropriately treated prior to Screening
    13. Treatment with any other investigational therapy or medical device within 30 days or within 5 half-lives, whatever is longer, prior to Screening
    14. Any other condition(s) that would compromise the safety of the subject or compromise the quality of the clinical study as judged by the Investigator



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