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

NCT ID: NCT02932449

Last Updated: 2025-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-10-31

Study Completion Date

2025-01-23

Brief Summary

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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.

Detailed Description

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Conditions

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Biliary Cirrhosis, Primary

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Target PharmaSolutions, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Institute for Liver Health

Chandler, Arizona, United States

Site Status

Banner University Medical Center

Phoenix, Arizona, United States

Site Status

Mayo Clinic

Phoenix, Arizona, United States

Site Status

University of Arkansas

Little Rock, Arkansas, United States

Site Status

Stanford University Medical Center

Palo Alto, California, United States

Site Status

California Liver Research Institute

Pasadena, California, United States

Site Status

University of California Davis

Sacramento, California, United States

Site Status

University of Colorado- Anschutz Medical Campus

Aurora, Colorado, United States

Site Status

Yale Internal Medicine, Digestive Diseases

New Haven, Connecticut, United States

Site Status

Gastro Florida

Clearwater, Florida, United States

Site Status

University of Florida Hepatology Research

Gainesville, Florida, United States

Site Status

SCFLD/University of Miami

Miami, Florida, United States

Site Status

Piedmont Atlanta Hospital

Atlanta, Georgia, United States

Site Status

Illinois Gastroenterology Group

Arlington Heights, Illinois, United States

Site Status

Rush University Medical Center

Chicago, Illinois, United States

Site Status

University of Chicago

Chicago, Illinois, United States

Site Status

University of Iowa

Iowa City, Iowa, United States

Site Status

Mercy Medical Center, GI Research

Baltimore, Maryland, United States

Site Status

University of Michigan

Ann Arbor, Michigan, United States

Site Status

Southern Therapy and Advanced Research LLC (STAR)

Jackson, Mississippi, United States

Site Status

Saint Louis University

St Louis, Missouri, United States

Site Status

University of Nebraska

Omaha, Nebraska, United States

Site Status

Sandra Atlas Bass Center for Liver Diseases

Manhasset, New York, United States

Site Status

NYU Langone Health

New York, New York, United States

Site Status

Weill Cornell Medical College

New York, New York, United States

Site Status

Columbia University Medical Center

New York, New York, United States

Site Status

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Site Status

Center for Liver Disease and Transplant at CMC

Charlotte, North Carolina, United States

Site Status

Duke University Medical Center

Durham, North Carolina, United States

Site Status

Ohio State University Medical Center

Columbus, Ohio, United States

Site Status

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

UT Southwestern Medical Center

Dallas, Texas, United States

Site Status

Baylor,Scott and White All Saints

Fort Worth, Texas, United States

Site Status

Liver Associates of Texas, P.A.

Houston, Texas, United States

Site Status

Pinnacle Clinical Research

Live Oak, Texas, United States

Site Status

Bon Secours Liver Institute of Virginia

Richmond, Virginia, United States

Site Status

Virginia Commonwealth University (VCU)

Richmond, Virginia, United States

Site Status

University of Washington

Seattle, Washington, United States

Site Status

University of Wisconsin

Madison, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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TARGET-PBC

Identifier Type: -

Identifier Source: org_study_id

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