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

Overview

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

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

Clinical Trials