An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in Subjects with Primary Biliary Cholangitis (PBC)
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)
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
340
Participants will be assigned to a treatment group if tolerability issues noted in the previous study.
Participants will be assigned to a treatment group unless there are tolerability issues.
Treatment emergent adverse events (TEAEs) (National Cancer Institute {NCI} Common Terminology Criteria for Adverse Events {CTCAE} Version 5.0), biochemistry and hematology results
Time frame: Through study completion, up to 60 Months
Death
Occurrence of overall death
Time frame: 60 Months
Liver transplantation
Occurrence of overall liver transplantation
Time frame: 60 Months
Change in MELD
MELD score ≥ 15 for at least 2 consecutive visits
Time frame: 60 Months
Ascites
Occurrence of overall ascites requiring treatment
Time frame: 60 Months
Hospitalization for variceal bleeding
Hospitalization for new onset, or recurrence, of variceal bleeding
Time frame: 60 Months
Hospitalization for hepatic encephalopathy
Hospitalization for new onset, or recurrence, hepatic encephalopathy (as defined by a West Haven score ≥ 2)
Time frame: 60 Months
Hospitalization for spontaneous bacterial peritonitis
Hospitalization for new onset, or recurrence, spontaneous bacterial peritonitis (confirmed by culture from diagnostic paracentesis)
Time frame: 60 Months
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Arkansas Diagnostic Center
Little Rock, Arkansas, United States
Stanford University School of Medicine
Palo Alto, California, United States
California Liver Research Institute
Pasadena, California, United States
University of California Davis Medical Center
Sacramento, California, United States
California Pacific Medical Center
San Francisco, California, United States
University of Colorado - Denver - PPDS
Aurora, Colorado, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Covenant Research Fort Myers
Fort Myers, Florida, United States
Florida Digestive Health Specialist
Lakewood Rch, Florida, United States
University of Miami Miller School of Medicine
Miami, Florida, United States
...and 99 more locations
Response on composite endpoint
Alkaline phosphate (ALP)
Time frame: 60 Months
Response on composite endpoint
Total bilirubin
Time frame: 60 Months
Normalization of ALP
Proportion of subjects with normalization of ALP
Time frame: 60 Months
Laboratory Value: Serum Alkaline Phosphatase (ALP)
Serum Alkaline Phosphatase (ALP)
Time frame: Through study completion, up to 60 Months
Laboratory Value: Aspartate Aminotransferase (AST)
Aspartate Aminotransferase (AST)
Time frame: Through study completion, up to 60 Months
Laboratory Value: Alanine Aminotransferase (ALT)
Alanine Aminotransferase (ALT)
Time frame: Through study completion, up to 60 Months
Laboratory Value: Gamma-glutamyl Transferase (GGT)
Gamma-glutamyl Transferase (GGT)
Time frame: Through study completion, up to 60 Months
Laboratory Value: Bilirubin - Total Bilirubin
Bilirubin - Total Bilirubin
Time frame: Through study completion, up to 60 Months
Laboratory Value: Bilirubin - Conjugated Bilirubin
Bilirubin - Conjugated Bilirubin
Time frame: Through study completion, up to 60 Months
Laboratory Value: Bilirubin - Unconjugated Bilirubin
Bilirubin - Unconjugated Bilirubin
Time frame: Through study completion, up to 60 Months