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PBC drug combo safety check ends early

NCT ID NCT06488911

Disease control Sponsor: Intercept Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at the long-term safety of a fixed-dose combination of two drugs (obeticholic acid and bezafibrate) for people with primary biliary cholangitis (PBC), a chronic liver disease. It enrolled 62 adults who had already been taking the combination in earlier studies. The study was terminated early, and its main goal was to track side effects, serious side effects, and changes in lab results. Because PBC requires ongoing treatment, this is classified as disease control, not a cure.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

62 people

The number who actually took part.

Started

Jul 2024

Finished

Oct 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * All subjects with PBC who participated and are actively taking investigational product in Study 747-213 or Study 747-214 are eligible to enroll in this study (977-311). Exclusion Criteria: * History or presence of other concomitant liver diseases * Clinical complications of PBC * History or presence of hepatic 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. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

primary biliary cholangitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Primary biliary cholangitis

Contacts and locations

Locations

  • Academisch Medisch Centrum

    Amsterdam, 1005 AZ, Netherlands

  • Akershus University Hospital

    Lørenskog, 1478, Norway

  • American Research Corporation

    San Antonio, Texas, 78215, United States

  • Artroscan s.r.o. Gastroenterologicka

    Ostrava, 722100, Czechia

  • Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi

    Bologna, Italy

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215, United States

  • CHRU de Lille

    Lille, 59000, France

  • CHU Paris Est - Hopital Saint Antoine

    Paris, 75012, France

  • Consorcio Hospital General Universitario

    Valencia, 46014, Spain

  • DEOEC II. sz. Belgygyszati Klinika

    Debrecen, 4032, Hungary

  • DIM Clinica Privada

    Buenos Aires, Argentina

  • East Tennessee Research Institute

    Johnson City, Tennessee, 37604, United States

  • Ege University, Faculty of Medicine, Gastroenterology

    Bornova, Turkey (Türkiye)

  • Flinders Medical Centre

    Bedford Park, 5042, Australia

  • Gastro One

    Germantown, Tennessee, 38138, United States

  • Hacettepe University, Faculty of Medicine, Adult Hospital Gastroenterology

    Ankara, Turkey (Türkiye)

  • Hadassah Ein-Karem Medical Center - Liver unit

    Jerusalem, 9112001, Israel

  • Harran University Hospital, Gastroenterology

    Sanliurfa, Turkey (Türkiye)

  • Hepato-Gastroenterologie HK, s.r.o.

    Hradec Králové, 50012, Czechia

  • Hopital Henri Mondor

    Créteil, 94000, France

  • Hopital de la Pitie Salpetriere

    Paris, 75013, France

  • Hospital ClinicUniversity of Barcelona

    Barcelona, 8036, Spain

  • Hospital Italiano de Buenos Aires

    Buenos Aires, Argentina

  • Hospital Italiano de La Plata

    Buenos Aires, Argentina

  • Hospital Provincial del Centenario

    Santa Fe, Argentina

  • Hospital Universitario Austral

    Buenos Aires, Argentina

  • Houston Methodist Hospital

    Houston, Texas, 77030, United States

  • Hull University Teaching Hospitals NHS Trust

    Hull, HU32JZ, United Kingdom

  • Institute of Cellular Medicine Newcastle University

    Newcastle upon Tyne, NE7 7DN, United Kingdom

  • Istanbul University, Capa Faculty of Medicine, Gastroenterology

    Istanbul, Turkey (Türkiye)

  • John Radcliffe Hospital

    Oxford, OX3 9DU, United Kingdom

  • Kyungpook National University Hospital

    Daegu, 41944, South Korea

  • Medizinische Hochschule Hannover

    Hanover, 30625, Germany

  • NYU Langone Health

    New York, New York, 10016, United States

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121, United States

  • Pacific Gastroenterology Associates GI Research Institute

    Vancouver, British Columbia, Canada

  • Piedmont Atlanta Hospital

    Atlanta, Georgia, 30309, United States

  • Research Site SRO

    Pilsen, 30100, Czechia

  • Royal Adelaide Hospital

    Adelaide, 5000, Australia

  • Seoul National University Bundang Hospital

    Seongnam-si, 463-707, South Korea

  • Southern California Research Center

    Coronado, California, 92118, United States

  • Tampa General Medical Group

    Tampa, Florida, 33606, United States

  • Tartu University Hospital

    Tartu, 50090, Estonia

  • The Liver Institute at Methodist Dallas Medical Center

    Dallas, Texas, 75203, United States

  • UZ Leuven

    Leuven, 3000, Belgium

  • University Hopital Santaros klinikos

    Vilnius, 8661, Lithuania

  • University Hospital of Larissa

    Larissa, 41110, Greece

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106, United States

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233, United States

  • University of Alberta Division of Gastroenterology Zeidler Ledcor Centre

    Edmonton, Alberta, Canada

  • Universityl Hospital Dubrava

    Zagreb, 10 000, Croatia

More trials for these conditions

Other studies related to the condition(s) this trial covers.