EUCTR2020-005198-29-NLActive, not recruitingPhase 1
ASSURE: An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in Subjects with Primary Biliary Cholangitis (PBC) - ASSURE
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- CymaBay Therapeutics, Inc.
- Enrollment
- 500
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. Must have given informed consent (signed and dated)
- •2. Participated in a previous PBC study with seladelpar (including CB8025-21629, CB8025-31735, or CB8025-21838) or future PBC studies with seladelpar that allow rollover into CB8025-31731-RE, or were previously enrolled in study CB8025-31731 prior to the early termination of the study, and meet eligibility criteria for the current study.
- •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
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 428
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 72
Exclusion Criteria
- •Exclusion criteria are only applicable for subjects with a study drug 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 AE leading to study drug discontinuation in a previous PBC study with seladelpar
- •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 × ULN
- •5. Model for End-Stage Liver Disease (MELD) score = 15
- •6. Evidence of advanced PBC as defined by the Rotterdam criteria (albumin below 1 × lower limit of normal AND total bilirubin above 1 × ULN)
- •7. Estimated glomerular filtration rate (eGFR) below 60 mL/min/1.73 m2 (calculated by Modification of Diet in Renal Disease 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
Investigators
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