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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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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adults with PBC who are being seen specifically to address this disease process
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute for Liver Health | Chandler | Arizona | 85224 | United States | ||
| Banner University Medical Center |
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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.
| 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 |
| ID | Term |
|---|---|
| D008105 | Liver Cirrhosis, Biliary |
| ID | Term |
|---|---|
| D002780 | Cholestasis, Intrahepatic |
| D002779 | Cholestasis |
| D001649 | Bile Duct Diseases |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D008103 | Liver Cirrhosis |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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