Summary

for people ages 18-75 (full criteria)
at Sacramento, California and other locations
study started
estimated completion

Description

Summary

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

Official Title

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

Details

Primary:

To evaluate the long-term safety and tolerability of seladelpar

Secondary:

To evaluate the long-term efficacy of seladelpar

Keywords

Primary Biliary Cirrhosis PBC Primary Biliary Cholangitis (PBC) Cholangitis Liver Cirrhosis, Biliary Seladelpar 2 mg Capsule Seladelpar 5 mg Capsule Seladelpar 10 mg Capsule Seladelpar 5 mg Capsules

Eligibility

You can join if…

Open to people ages 18-75

  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

You CAN'T join if...

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

Locations

  • University of California, Davis Medical Center accepting new patients
    Sacramento California 95817 United States
  • Stanford Healthcare accepting new patients
    Palo Alto California 94305 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
CymaBay Therapeutics, Inc.
Links
Sign up for this study
ID
NCT03301506
Phase
Phase 2/3
Study Type
Interventional
Last Updated