Status:
COMPLETED
Study of OCA in Combination With BZF Evaluating Efficacy, Safety and Tolerability in Participants With PBC
Lead Sponsor:
Intercept Pharmaceuticals
Conditions:
Primary Biliary Cholangitis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Study to determine the effect of the investigational drug bezafibrate (BZF) alone and in combination with the investigational drug obeticholic acid (OCA) in participants with Primary Biliary Cholangit...
Eligibility Criteria
Inclusion
- A definite or probable diagnosis of PBC
- Qualifying ALP and/or bilirubin liver biochemistry values
- Taking ursodeoxycholic acid (UDCA) for at least 12 months or no UDCA for 3 months before Day 1
Exclusion
- History or presence of other concomitant liver diseases
- Presence of clinical complications of PBC
- History or presence of decompensating events
- Current or history of gallbladder disease
- If female, known pregnancy, or has a positive urine pregnancy test (confirmed by a positive serum pregnancy test), or lactating
- Treatment with commercially available OCA or participation in a previous study involving OCA, or other farnesoid X receptor (FXR) agonists, or peroxisome proliferator activated receptor (PPAR)-agonists within 3 months before Screening
- Unable to tolerate BZF or other fibrates, treatment with commercially available fibrates, or participation in a previous study involving fibrate within 3 months before Screening.
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Key Trial Info
Start Date :
March 21 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2025
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT05239468
Start Date
March 21 2022
End Date
September 1 2025
Last Update
September 25 2025
Active Locations (26)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
2
Southern California Gastrointestinal (GI) and Liver Centers (SCLC) - Coronado
Coronado, California, United States, 92118
3
Facey Medical Group
Mission Hills, California, United States, 91345
4
Schiff Center for Liver Diseases / University of Miami
Miami, Florida, United States, 33136