Trial Search Results

Seladelpar in Subjects With Primary Biliary Cholangitis (PBC)

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

Stanford is currently accepting patients for this trial.

Lead Sponsor:

CymaBay Therapeutics, Inc.

Stanford Investigator(s):

Intervention(s):

  • Drug: Seladelpar 5 mg Capsule
  • Drug: Seladelpar 10 mg Capsule

Phase:

Phase 3

Eligibility


Inclusion Criteria:

   1. Must have given written informed consent (signed and dated)

   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 only applicable for subjects with a seladelpar interruption greater
than 4 weeks prior to Day 1 of this study and for subjects who participated in CB8025-21838
irrespective of seladelpar interruption.

   1. Treatment-related adverse event (AE) leading to seladelpar 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 × the upper limit of normal (ULN)

   4. Total bilirubin above 2 × ULN

   5. MELD score ≥ 12. For subjects on anticoagulation medication, evaluation of the
   baseline INR, in concert with any current dose adjustments in anti-coagulant
   medications, will be taken into account when calculating this score. This will be done
   in consultation with the medical monitor.

   6. Evidence of advanced PBC as defined by the Rotterdam criteria: albumin below 1× the
   lower limit of normal (LLN) AND total bilirubin above 1 × ULN)

   7. eGFR ≤45 mL/min/1.73 m2 (calculated by MDRD formula)

   8. Auto-immune hepatitis

   9. Primary sclerosing cholangitis

10. Known history of alpha-1-antitrypsin deficiency

11. Known history of chronic viral hepatitis

12. For females, pregnancy or breast-feeding

13. Use of colchicine, methotrexate, azathioprine, or long-term use of systemic steroids
   (e.g. prednisone, prednisolone, budesonide) (>2 weeks) within 2 months prior to
   Screening

14. Current use of fibrates or use of fibrates within 3 months prior to Screening

15. Current use of obeticholic acid or use of obeticholic acid within 3 months prior to
   Screening

16. Use of an experimental or unapproved treatment for PBC within 3 months prior to
   Screening

17. 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

18. Treatment with any other investigational therapy or medical device within 30 days or
   within 5 half-lives, whatever is longer, prior to Screening

19. 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

20. Immunosuppressant therapies (e.g., cyclosporine, tacrolimus, anti-TNF or other
   immunosuppressive biologics)

21. Other medications that effect liver or GI functions such as absorption of medications
   or the roux-en-y gastric bypass procedure may be prohibited and should be discussed
   with the medical monitor on a case-by-case basis

22. Positive for:

      1. Hepatitis B, defined as the presence of hepatitis B surface antigen

      2. Hepatitis C, defined as the presence of hepatitis C virus ribonucleic acid (RNA)

      3. Human immunodeficiency virus (HIV) antibody

23. Active COVID-19 infection during screening

Ages Eligible for Study

18 Years - 75 Years

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Jennifer Smart
650-721-8517
Recruiting