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

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.

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Key information

Conditions

Biliary Cirrhosis, Primary Bile Duct Diseases Biliary Tract Diseases Cholestasis Cholestasis, Intrahepatic Digestive System Diseases Fibrosis Liver Cirrhosis Liver Cirrhosis, Biliary Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Institute for Liver Health, Chandler, Arizona, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Evaluate PBC treatment regimens being used in clinical practice

Time frame: up to 5 years
Examine populations underrepresented in phase III clinical trials

Time frame: up to 5 years
Examine biochemical response and its association with long term outcomes

Time frame: up to 5 years
Estimate adverse event frequency and severity and describe management practices

Time frame: up to 5 years

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Target PharmaSolutions, Inc.

Industry

Registry information

Important dates

Study start: 2016
Primary completion: 2025
Study completion: 2025
First posted: Oct 13, 2016
Registry last updated: Feb 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed