An Open Label Long-Term Study to Evaluate the Safety and Tolerability of the Fixed-Dose Combination (FDC) of Obeticholic Acid (OCA) and Bezafibrate (BZF) tablet in Subjects with Primary Biliary Cholangitis (PBC).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
62
Participants will be administered with FDC tablets once daily.
Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Leading to Discontinuation
A TEAE was defined as any event not present before the initiation of the investigational product in this study or any event already present, which worsened in either severity or frequency following exposure to the investigational product in this study. A serious TEAE was defined as any untoward medical occurrence that at any dose resulted in death, life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital abnormality or birth defect, an important medical event that may jeopardize the participant or may require medical intervention.
Time frame: Early Termination (Up to Month 12)
Number of Participants Reporting Severe TEAEs
A severe (Grade 3) TEAE is defined as an AE that causes inability to carry out usual activities; the subject may experience intolerable discomfort or pain.
Time frame: Early Termination (Up to Month 12)
Number of Participants Reporting All-Cause Mortality
All-cause mortality included all reported deaths of participants during the study due to any cause.
Time frame: Early Termination (Up to Month 12)
Number of Participants With Clinically Significant Changes in Baseline in Clinical Hematology Parameters
Clinically notable shift from baseline in blood hematology parameters data was presented for low and high numbers of participants at early termination visit (up to Month 12). The number of participants with clinically notable shift from baseline was presented.
Time frame: Early Termination (Up to Month 12)
Number of Participants With Clinically Significant Changes in Baseline in Blood Serum Chemistry Parameters
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Southern California Research Center
Coronado, California, United States
Tampa General Medical Group
Tampa, Florida, United States
Piedmont Atlanta Hospital
Atlanta, Georgia, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
NYU Langone Health
New York, New York, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Gastro One
Germantown, Tennessee, United States
East Tennessee Research Institute
Johnson City, Tennessee, United States
...and 41 more locations
Clinically notable shift from baseline in blood serum chemistry data were presented for low and high numbers of participants at early termination visit (up to Month 12). Change from baseline was calculated as post baseline value minus baseline value. Baseline was defined as the last assessment performed before the first dose of investigational product in Study 977-311.
Time frame: Early Termination (Up to Month 12)