A 5-year Longitudinal Observational Study of Patients with Primary Biliary Cholangitis
| Sponsor: |
TARGET PharmaSolutions, Inc. |
| Enrolling: |
Male and Female Patients |
| IRB Number: |
AAAR1437 |
| U.S. Govt. ID: |
NCT02932449 |
| Contact: |
Cristina Falo, PhD: 1 212 305 6758 / cf2427@cumc.columbia.edu |
Primary biliary cholangitis (PBC) is a chronic, or long-term, disease of the liver characterized by damaged bile ducts due to inflammation. The main purpose of this research study is to collect study information on patients with PBC. Researchers are interested in observing how lifestyle changes, counseling, or other treatments work in patients who are treated by their doctors in routine practice. There will be a main study and two additional sub-studies. In the main study, participants past and future medical records related to their PBC (including any available liver pathology slides, imaging and labs) will be collected and sent to the Sponsor to be stored in a private and secure computer database. In addition to the main study, the study team will ask participants if they would like to take part in the Optional TARGET PBC Biorepository Sub-Study where they will be asked to provide additional blood for future research. The study team will also ask the participant if they would like to participate in an optional PRO Survey sub-study. Participants will be asked to complete three optional PRO surveys every 6-12 months via a web-based system. Participation in this study may last up to 5 years. This study will be conducted at up to 30 academic and community clinical centers. Up to 1,500 participants with PBC will be enrolled. Approximately 50 subjects may participate in this study at Columbia University Medical Center.
This study is closed
Investigator
Elizabeth Verna, MD
| Do you have primary biliary cholangitis (PBC), a chronic, long-term disease of the liver? |
Yes |
No |