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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02932449

Enrollment

711

Registered

2016-10-13

Start date

2016-10-01

Completion date

2025-01-23

Last updated

2026-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biliary Cirrhosis, Primary

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Adult patients (age 18 or older) being treated or managed for PBC

Exclusion criteria

* Inability to provide written informed consent * Simultaneous enrollment in another prospective registry or clinical trial or study where PBC treatment outcomes are reported, except where approved or conducted as an adjunct project of TARGET-PBC

Design outcomes

Primary

Measure	Time frame
Examine populations underrepresented in phase III clinical trials	up to 5 years
Examine biochemical response and its association with long term outcomes	up to 5 years
Estimate adverse event frequency and severity and describe management practices	up to 5 years
Evaluate PBC treatment regimens being used in clinical practice	up to 5 years

Countries

United States

Outcome results