Liver Institute Northwest | Seattle, WA
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An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in Subjects with Primary Biliary Cholangitis (PBC)
Full description
Primary:
To evaluate the long-term safety and tolerability of seladelpar
Secondary:
Enrollment
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Inclusion criteria
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 ≥ 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.
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 ≤45 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
Immunosuppressant therapies (e.g., cyclosporine, tacrolimus, anti-TNF or other immunosuppressive biologics)
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
Positive for:
Active COVID-19 infection during screening
Primary purpose
Allocation
Interventional model
Masking
500 participants in 2 patient groups
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Central trial contact
Barry Crittenden, MD
Data sourced from clinicaltrials.gov
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