The purposes of this study are to evaluate the treatment effect of seladelpar on composite biochemical improvement in cholestasis markers based on ALP and total bilirubin and to evaluate the safety of seladelpar over 12 months of treatment compared to placebo. The study also checked the effect of treatment on the symptoms of PBC, including pruritus.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
193
Seladelpar 10 mg one capsule daily for double-blind period, for a duration of up to 12 months
One capsule daily for double-blind period, for a duration of up to 12 months
If down-titration needed, one capsule daily for double-blind period, for a duration of up to 12 months
Percentage of Participants With Response Criteria for the Composite Endpoint of ALP <1.67 × Upper Limit of Normal (ULN), ≥15% Reduction in ALP, and Total Bilirubin ≤ 1.0× ULN at Month 12
Percentages were rounded-off.
Time frame: Month 12
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs
Percentages were rounded-off.
Time frame: First dose date up to last dose plus 30 days (up to 13.4 months)
Percentage of Participants With Shift of ≥ 2 CTCAE Grades From Baseline in Treatment-emergent Laboratory Abnormalities Related to Hematology and Select Liver Biochemistry
Treatment-emergent graded laboratory abnormalities were defined as values that increase at least 2 toxicity grade from baseline at any time post baseline. The laboratory abnormalities were graded using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), where Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: potentially life-threatening laboratory abnormality. The data is reported for shift of ≥ 2 grades from baseline in values for hematology and select liver biochemistry. Hematology includes parameters like RBCs, (erythrocytes), hemoglobin, hematocrit, platelets, WBC, WBC differentials (absolute and percentage) including basophils, neutrophils, lymphocytes, eosinophils, and monocytes, etc. Biochemistry included select liver function tests like blood bilirubin, gamma-glutamyl transferase (GGT), aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase. Percentages were rounded-off.
Time frame: First dose date up to last dose (up to 13.4 months)
Percentage of Participants With ALP ≤1.0× ULN at Month 12
Percentages were rounded-off.
Time frame: Month 12
Change From Baseline in Weekly Averaged Pruritus Numerical Rating Scale (NRS) in Participants With NRS ≥ 4 at Month 6
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
The Institute for Liver Health DBA Arizona Liver Health
Chandler, Arizona, United States
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 - Sutter Pacific Medical Foundation
San Francisco, California, United States
Covenant Metabolic Specialists, LLC
Fort Myers, Florida, United States
Florida Research Institute
Lakewood Rch, Florida, United States
Schiff Center for Liver Diseases/University of Miami
Miami, Florida, United States
Covenant Research and Clinics, LLC
Sarasota, Florida, United States
...and 124 more locations
Pruritus NRS is used to rate the intensity of the itching experienced by the participants in the past 24 hours from no itching to worst possible itching by selecting a number from 0 to 10 on Itch Scale. Zero means no itching and 10 means worst imaginable itching.
Time frame: Baseline, Month 6