Last updated on December 2019

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 cirrhosis
  • Age: Between 18 - 75 Years
  • Gender: Male or Female

Inclusion Criteria:

  1. Must have given written informed consent (signed and dated) and any authorizations required by local law
  2. Participated in a PBC study with seladelpar
  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. 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

Exclusion Criteria:

Exclusion criteria are applicable only for subjects with study drug interruption greater than four weeks prior to Day 1 of this study.

  1. Treatment-related adverse event leading to study drug discontinuation in a previous PBC study with seladelpar (MBX-8025)
  2. A medical condition, other than PBC, that in the investigator's opinion would preclude full participation in the study or confound its results (e.g., cancer)
  3. AST or ALT above 3 ULN
  4. Total bilirubin above 2.0 mg/dL
  5. Creatine kinase above 2.5 ULN
  6. Serum creatinine above 1.5 ULN
  7. Auto-immune hepatitis
  8. Primary sclerosing cholangitis
  9. Known history of alpha-1-antitrypsin deficiency
  10. Known history of chronic viral hepatitis
  11. For females, pregnancy or breast-feeding
  12. Use of colchicine, methotrexate, azathioprine, or systemic steroids within two months prior to screening
  13. Current use of fibrates or simvastatin
  14. Current use of obeticholic acid
  15. Use of an experimental or unapproved treatment for PBC
  16. Use of experimental or unapproved immunosuppressant
  17. 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

Recruitment Status: Closed

Brief Description Eligibility Contact Research Team

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