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

Target PharmaSolutions

Status: Completed

Conditions: Biliary Cirrhosis, Primary

Study type: Observational

Funder types: Industry

Identifiers

NCT02932449

TARGET-PBC

Details and patient eligibility

About

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.

Enrollment: 1,500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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