MedTrace Logo

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

NCT04594694 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2025-11-17

No results posted yet for this study

Summary

Study to evaluate the efficacy, safety, and tolerability of investigational drug obeticholic acid (OCA) in combination with the investigational drug bezafibrate (BZF) in participants with Primary Biliary Cholangitis (PBC).

Conditions

Interventions

DRUG

Obeticholic acid

5 mg tablet of OCA once daily titrating up to a maximum of 10 mg OCA once daily

DRUG

Bezafibrate 200 MG

200 mg IR tablet of Bezafibrate once daily for the remainder of the study

DRUG

OCA Placebo

One tablet daily for the remainder of the study

DRUG

Bezafibrate 200 mg Placebo

One tablet daily for the remainder of the study

DRUG

Bezafibrate 400 MG

400 mg SR tablet of Bezafibrate once daily for the remainder of the study

DRUG

Bezafibrate 400 mg Placebo

One tablet daily for the remainder of the study

DRUG

OCA

OCA one tablet will be administered.

DRUG

Bezafibrate

Bezafibrate one tablet will be administered.

Sponsors & Collaborators

  • Intercept Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Lynda Szczech · Intercept Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-02
Primary Completion
2025-10-14
Completion
2025-10-14

Countries

  • Australia
  • Belgium
  • Croatia
  • Czechia
  • Estonia
  • France
  • Germany
  • Greece
  • Hungary
  • Israel
  • Lithuania
  • Netherlands
  • Norway
  • Poland
  • South Korea
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04594694 on ClinicalTrials.gov