Study of OCA in Combination With BZF Evaluating Efficacy, Safety and Tolerability in Patients With PBC

  • End date
    Dec 14, 2023
  • participants needed
  • sponsor
    Intercept Pharmaceuticals
Updated on 7 October 2022


Study to determine the effect of the investigational drug bezafibrate (BZF) alone and in combination with the investigational drug obeticholic acid (also known as OCA) in patients with Primary Biliary Cholangitis (also known as PBC).

Condition Primary Biliary Cholangitis
Treatment Obeticholic acid placebo, Bezafibrate 200 MG, Bezafibrate 100 MG, Obeticholic Acid 5 MG, Bezafibrate Placebo
Clinical Study IdentifierNCT05239468
SponsorIntercept Pharmaceuticals
Last Modified on7 October 2022


Yes No Not Sure

Inclusion Criteria

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 Criteria

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 FXR agonists, or peroxisome proliferator activated receptor (PPAR)-agonists within 3 months before Screening
Treatment with commercially available fibrates, or participation in a previous study involving fibrate within 3 months before Screening
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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