A 5-year Longitudinal Observational Study of Patients With Primary Biliary Cholangitis

February 16, 2026 updated by: Target PharmaSolutions, Inc.
This is a 5-year, longitudinal, observational study of patients with PBC designed to specifically address important clinical questions that remain incompletely answered from registration trials. In addition to the study database, a bio specimen repository will also be included so that translational studies of genomics and biomarkers of response may be performed.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

711

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Institute for Liver Health
      • Phoenix, Arizona, United States, 85054
        • Mayo Clinic
      • Phoenix, Arizona, United States, 85006
        • Banner University Medical Center
    • Arkansas
      • Little Rock, Arkansas, United States, 72204
        • University of Arkansas
    • California
      • Palo Alto, California, United States, 94304
        • Stanford University Medical Center
      • Pasadena, California, United States, 91105
        • California Liver Research Institute
      • Sacramento, California, United States, 95817
        • University of California Davis
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado- Anschutz Medical Campus
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Yale Internal Medicine, Digestive Diseases
    • Florida
      • Clearwater, Florida, United States, 33762
        • Gastro Florida
      • Gainesville, Florida, United States, 32610
        • University of Florida Hepatology Research
      • Miami, Florida, United States, 33136
        • SCFLD/University of Miami
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Piedmont Atlanta Hospital
    • Illinois
      • Arlington Heights, Illinois, United States, 60005
        • Illinois Gastroenterology Group
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
      • Chicago, Illinois, United States, 60637
        • University of Chicago
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa
    • Maryland
      • Baltimore, Maryland, United States, 21202
        • Mercy Medical Center, GI Research
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • Southern Therapy and Advanced Research LLC (STAR)
    • Missouri
      • St Louis, Missouri, United States, 63104
        • Saint Louis University
    • Nebraska
      • Omaha, Nebraska, United States, 68106
        • University of Nebraska
    • New York
      • Manhasset, New York, United States, 11030
        • Sandra Atlas Bass Center for Liver Diseases
      • New York, New York, United States, 10032
        • Columbia University Medical Center
      • New York, New York, United States, 10016
        • NYU Langone Health
      • New York, New York, United States, 10021
        • Weill Cornell Medical College
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina at Chapel Hill
      • Charlotte, North Carolina, United States, 28204
        • Center for Liver Disease and Transplant at CMC
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Ohio State University Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania
    • Texas
      • Dallas, Texas, United States, 75390
        • UT Southwestern Medical Center
      • Fort Worth, Texas, United States
        • Baylor,Scott and White All Saints
      • Houston, Texas, United States, 77030
        • Liver Associates of Texas, P.A.
      • Live Oak, Texas, United States, 78233
        • Pinnacle Clinical Research
    • Virginia
      • Richmond, Virginia, United States, 23226
        • Bon Secours Liver Institute of Virginia
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University (VCU)
    • Washington
      • Seattle, Washington, United States, 98104
        • University of Washington
    • Wisconsin
      • Madison, Wisconsin, United States, 53705
        • University of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

adults with PBC who are being seen specifically to address this disease process

Description

Inclusion Criteria:

  • Adult patients (age 18 or older) being treated or managed for PBC

Exclusion Criteria:

  • Inability to provide written informed consent
  • Simultaneous enrollment in another prospective registry or clinical trial or study where PBC treatment outcomes are reported, except where approved or conducted as an adjunct project of TARGET-PBC

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluate PBC treatment regimens being used in clinical practice
Time Frame: up to 5 years
up to 5 years
Examine populations underrepresented in phase III clinical trials
Time Frame: up to 5 years
up to 5 years
Examine biochemical response and its association with long term outcomes
Time Frame: up to 5 years
up to 5 years
Estimate adverse event frequency and severity and describe management practices
Time Frame: up to 5 years
up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Target PharmaSolutions, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (Actual)

January 23, 2025

Study Completion (Actual)

January 23, 2025

Study Registration Dates

First Submitted

September 7, 2016

First Submitted That Met QC Criteria

October 11, 2016

First Posted (Estimated)

October 13, 2016

Study Record Updates

Last Update Posted (Actual)

February 18, 2026

Last Update Submitted That Met QC Criteria

February 16, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TARGET-PBC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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