CompletedNot Applicable

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

United States711 participantsStarted 2016-10

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Evaluate PBC treatment regimens being used in clinical practice

Timeframe: up to 5 years

Examine populations underrepresented in phase III clinical trials

Timeframe: up to 5 years

Examine biochemical response and its association with long term outcomes

Timeframe: up to 5 years

Estimate adverse event frequency and severity and describe management practices

Timeframe: up to 5 years

Trial details

NCT IDNCT02932449

SponsorTarget PharmaSolutions, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-01-23

View on ClinicalTrials.gov More Biliary Cirrhosis, Primary trials