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

Overview

  • Study type

    Observational
  • Study IDs

  • Describes 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.
  • 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. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

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 us for help.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Elizabeth Carey, M.D.

Contact us for the latest status

Contact information:

Alicia Rankin

7926995

Rankin.Alicia@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20313736

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