A 5-year Longitudinal Observational Study of Patients With Primary Biliary Cholangitis
1 other identifier
observational
711
1 country
39
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2016
Longer than P75 for all trials
39 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 7, 2016
CompletedStudy Start
First participant enrolled
October 1, 2016
CompletedFirst Posted
Study publicly available on registry
October 13, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 23, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 23, 2025
CompletedFebruary 18, 2026
February 1, 2026
8.3 years
September 7, 2016
February 16, 2026
Conditions
Outcome Measures
Primary Outcomes (4)
Evaluate PBC treatment regimens being used in clinical practice
up to 5 years
Examine populations underrepresented in phase III clinical trials
up to 5 years
Examine biochemical response and its association with long term outcomes
up to 5 years
Estimate adverse event frequency and severity and describe management practices
up to 5 years
Eligibility Criteria
adults with PBC who are being seen specifically to address this disease process
You may qualify if:
- Adult patients (age 18 or older) being treated or managed for PBC
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (39)
Institute for Liver Health
Chandler, Arizona, 85224, United States
Banner University Medical Center
Phoenix, Arizona, 85006, United States
Mayo Clinic
Phoenix, Arizona, 85054, United States
University of Arkansas
Little Rock, Arkansas, 72204, United States
Stanford University Medical Center
Palo Alto, California, 94304, United States
California Liver Research Institute
Pasadena, California, 91105, United States
University of California Davis
Sacramento, California, 95817, United States
University of Colorado- Anschutz Medical Campus
Aurora, Colorado, 80045, United States
Yale Internal Medicine, Digestive Diseases
New Haven, Connecticut, 06520, United States
Gastro Florida
Clearwater, Florida, 33762, United States
University of Florida Hepatology Research
Gainesville, Florida, 32610, United States
SCFLD/University of Miami
Miami, Florida, 33136, United States
Piedmont Atlanta Hospital
Atlanta, Georgia, 30309, United States
Illinois Gastroenterology Group
Arlington Heights, Illinois, 60005, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
University of Chicago
Chicago, Illinois, 60637, United States
University of Iowa
Iowa City, Iowa, 52242, United States
Mercy Medical Center, GI Research
Baltimore, Maryland, 21202, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Southern Therapy and Advanced Research LLC (STAR)
Jackson, Mississippi, 39216, United States
Saint Louis University
St Louis, Missouri, 63104, United States
University of Nebraska
Omaha, Nebraska, 68106, United States
Sandra Atlas Bass Center for Liver Diseases
Manhasset, New York, 11030, United States
NYU Langone Health
New York, New York, 10016, United States
Weill Cornell Medical College
New York, New York, 10021, United States
Columbia University Medical Center
New York, New York, 10032, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Center for Liver Disease and Transplant at CMC
Charlotte, North Carolina, 28204, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Ohio State University Medical Center
Columbus, Ohio, 43210, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
UT Southwestern Medical Center
Dallas, Texas, 75390, United States
Baylor,Scott and White All Saints
Fort Worth, Texas, United States
Liver Associates of Texas, P.A.
Houston, Texas, 77030, United States
Pinnacle Clinical Research
Live Oak, Texas, 78233, United States
Bon Secours Liver Institute of Virginia
Richmond, Virginia, 23226, United States
Virginia Commonwealth University (VCU)
Richmond, Virginia, 23298, United States
University of Washington
Seattle, Washington, 98104, United States
University of Wisconsin
Madison, Wisconsin, 53705, United States
Biospecimen
Participants enrolled in TARGET-PBC will be invited to participate in the optional Biorepository Specimen Bank (BSB). Blood samples for biomarker and DNA/RNA assays will be collected on a voluntary basis and participation in this project will not affect participation in the main study. Blood samples for exploratory genetic and biomarker studies can be used for research purposes to identify potential biomarkers predictive of PBC diagnosis, assess correlates of response to PBC treatment (in terms of mode of action, efficacy, dose, safety and tolerability), understand factors influencing disease progression, determine how best to monitor and treat PBC, aid in the development of a new medical products, or explore complications of PBC and treatment.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 7, 2016
First Posted
October 13, 2016
Study Start
October 1, 2016
Primary Completion
January 23, 2025
Study Completion
January 23, 2025
Last Updated
February 18, 2026
Record last verified: 2026-02