Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Sacramento, California and other locations
Dates
study started
completion around

Description

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 Cholangitis (PBC).

Official Title

A Phase 2a, Double-Blind, Randomized, Active Controlled, Parallel Group Study Evaluating the Efficacy, Safety, and Tolerability of Bezafibrate Administered in Combination With Obeticholic Acid in Subjects With Primary Biliary Cholangitis

Keywords

Primary Biliary Cholangitis, Primary Biliary Cirrhosis, Hepatic Impairment, Cirrhosis, Liver, Cholangitis, Biliary Liver Cirrhosis, Chenodeoxycholic Acid, Bezafibrate, Bezafibrate 100 mg, Bezafibrate 200 mg, Obeticholic Acid 5 mg

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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.

Locations

  • UC Davis Medical Center
    Sacramento California 95817 United States
  • Facey Medical Group
    Mission Hills California 91345 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Intercept Pharmaceuticals
Links
Sign up for this study
ID
NCT05239468
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 60 study participants
Last Updated