Clinical Research Studies

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 years - 75 years
• Gender: Male or Female

• Other Inclusion Criteria:
  

  1. Subjects have given written informed consent (signed and dated) and any authorizations required by local law
  2. Subjects who have participated in a PBC study with seladelpar
  3. Female subjects 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. Subjects with treatment-related adverse event leading to study drug discontinuation in a previous PBC study with seladelpar
  2. Subjects with a medical condition, other than PBC, that in the investigator’s opinion would preclude full participation in the study or confound its results
  3. Subjects who have laboratory test results as per the protocol
  4. Subjects who are pregnant or breast-feeding
  5. Subjects who have known history of alpha-1-antitrypsin deficiency or chronic viral hepatitis
  6. Subjects who use of colchicine, methotrexate, azathioprine or systemic steroids within two months prior to screening
  7. Subjects who current use of fibrates or simvastatin or obeticholic acid
  8. Subjects who use of an experimental or unapproved treatment for PBC
  9. Subjects who use of experimental or unapproved immunosuppressant
  10. Subjects who have 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