A 5-year Longitudinal Observational Study of Patients With Primary Biliary Cholangitis
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Scottsdale/Phoenix, Arizona: 16-009839
NCT ID: NCT02932449
Sponsor Protocol Number: TARGET-PBC
About this study
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.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Adult patients (age 18 or older) being prescribed any treatment for PBC (initial or subsequent) outside of a clinical trial. A diagnosis of PBC requires the presence of at least 2 of the following 3 criteria: a. Unexplained elevation of serum alkaline phosphatase b. Positive anti-mitochondrial antibody at a titer ≥ 1:40 c. Liver biopsy showing both: i. compatible destructive nonsuppurative cholangitis and ii. destruction of interlobular bile ducts
Exclusion Criteria:
- Inability to provide written informed consent
- Current or planned participation in another registry or study where PBC treatment outcomes are reported, except where approved or conducted as an adjunct project of TARGET-PBC.
- Participation in a clinical trial at the time of enrollment in TARGET-PBC. Patient may enroll in TARGET-PBC once their participation in the clinical trial has ended.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Scottsdale/Phoenix, Ariz.
Mayo Clinic principal investigator Elizabeth Carey, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available