A 5-year Longitudinal Observational Study of Patients With Primary Biliary Cholangitis
- Conditions
- Biliary Cirrhosis, Primary
- Registration Number
- NCT02932449
- Lead Sponsor
- Target PharmaSolutions, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1500
- Adult patients (age 18 or older) being treated or managed for PBC
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Estimate adverse event frequency and severity and describe management practices up to 5 years Examine biochemical response and its association with long term outcomes up to 5 years 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (39)
Southern Therapy and Advanced Research LLC (STAR)
🇺🇸Jackson, Mississippi, United States
Sandra Atlas Bass Center for Liver Diseases
🇺🇸Manhasset, New York, United States
SCFLD/University of Miami
🇺🇸Miami, Florida, United States
Banner University Medical Center
🇺🇸Phoenix, Arizona, United States
Mayo Clinic
🇺🇸Phoenix, Arizona, United States
University of Nebraska
🇺🇸Omaha, Nebraska, United States
University of California Davis
🇺🇸Sacramento, California, United States
Illinois Gastroenterology Group
🇺🇸Arlington Heights, Illinois, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
University of Chicago
🇺🇸Chicago, Illinois, United States
NYU Langone Health
🇺🇸New York, New York, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
University of Florida Hepatology Research
🇺🇸Gainesville, Florida, United States
Institute for Liver Health
🇺🇸Chandler, Arizona, United States
University of Iowa
🇺🇸Iowa City, Iowa, United States
Weill Cornell Medical College
🇺🇸New York, New York, United States
Gastro Florida
🇺🇸Clearwater, Florida, United States
Piedmont Atlanta Hospital
🇺🇸Atlanta, Georgia, United States
Mercy Medical Center, GI Research
🇺🇸Baltimore, Maryland, United States
University of Arkansas
🇺🇸Little Rock, Arkansas, United States
University of Colorado- Anschutz Medical Campus
🇺🇸Aurora, Colorado, United States
Yale Internal Medicine, Digestive Diseases
🇺🇸New Haven, Connecticut, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Center for Liver Disease and Transplant at CMC
🇺🇸Charlotte, North Carolina, United States
University of Wisconsin
🇺🇸Madison, Wisconsin, United States
Stanford University Medical Center
🇺🇸Palo Alto, California, United States
California Liver Research Institute
🇺🇸Pasadena, California, United States
Ohio State University Medical Center
🇺🇸Columbus, Ohio, United States
University of North Carolina at Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Saint Louis University
🇺🇸Saint Louis, Missouri, United States
Bon Secours Liver Institute of Virginia
🇺🇸Richmond, Virginia, United States
University of Washington
🇺🇸Seattle, Washington, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Liver Associates of Texas, P.A.
🇺🇸Houston, Texas, United States
UT Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Virginia Commonwealth University (VCU)
🇺🇸Richmond, Virginia, United States
Baylor,Scott and White All Saints
🇺🇸Fort Worth, Texas, United States
Pinnacle Clinical Research
🇺🇸Live Oak, Texas, United States