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

  • Study HIC#:2000021495
  • Last Updated:07/12/2021

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.

  • Age18 years and older
  • GenderBoth
  • Start Date09/18/2017
  • End Date09/30/2021

Trial Purpose and Description

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.

Eligibility Criteria

Study Population

Adults with PBC who are being seen specifically to address this disease process

Criteria 

Inclusion Criteria: 

  1. Adult patients (age 18 or older) being prescribed any treatment for PBC (initial or subsequent) outside of a clinical trial.
  2. A diagnosis of PBC requires the presence of at least 2 of the following 3 criteria: 
    1. Unexplained elevation of serum alkaline phosphatase 
    2. Positive anti-mitochondrial antibody at a titer ≥ 1:40 
    3. Liver biopsy showing both: 
      1. compatible destructive nonsuppurative cholangitis and 
      2. destruction of interlobular bile ducts

Exclusion Criteria: 

  1. Inability to provide written informed consent 
  2. 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. 
  3. 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. 

Principal Investigator

Sub-Investigators

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