Seladelpar in Subjects With Primary Biliary Cholangitis (PBC)

  • STATUS
    Recruiting
  • End date
    Dec 16, 2025
  • participants needed
    500
  • sponsor
    CymaBay Therapeutics, Inc.
Updated on 16 June 2021
cirrhosis
cholangitis

Summary

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

Description

Primary

To evaluate the long-term safety and tolerability of seladelpar

Secondary
  • To evaluate the long-term efficacy of seladelpar
  • To evaluate the effect of seladelpar on patient-reported outcomes (pruritus)

Details
Condition Primary biliary cirrhosis, Cirrhosis, Primary Biliary Cholangitis, Hepatic Fibrosis
Treatment Seladelpar 2 mg Capsule, Seladelpar 5 mg Capsule, Seladelpar 10 mg Capsule
Clinical Study IdentifierNCT03301506
SponsorCymaBay Therapeutics, Inc.
Last Modified on16 June 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Must have given written informed consent (signed and dated)
Participated in a PBC study with seladelpar
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
Treatment-related adverse event (AE) leading to seladelpar discontinuation in a previous PBC study with seladelpar (MBX-8025)
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)
AST or ALT above 3 the upper limit of normal (ULN)
Total bilirubin above 2 ULN
MELD score 15
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)
eGFR below 60 mL/min/1.73 m2 (calculated by MDRD formula)
Auto-immune hepatitis
Primary sclerosing cholangitis
Known history of alpha-1-antitrypsin deficiency
Known history of chronic viral hepatitis
For females, pregnancy or breast-feeding
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
Current use of fibrates or use of fibrates within 3 months prior to Screening
Current use of obeticholic acid or use of obeticholic acid within 3 months prior to Screening
Use of an experimental or unapproved treatment for PBC within 3 months prior to Screening
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
Treatment with any other investigational therapy or medical device within 30 days or within 5 half-lives, whatever is longer, prior to Screening
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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