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

Completed

• Conditions: Biliary Cirrhosis, Primary

• Registration Number: NCT02932449
• Lead Sponsor: Target PharmaSolutions, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-09-07
• Study Start: 2016-10
• Study First Submitted QC: 2016-10-11
• Study First Posted: 2016-10-13
• Status Verified: 2025-01
• Primary Completion: 2025-01-23
• Study Completion: 2025-01-23
• Last Update Submitted: 2025-01-28
• Last Update Posted: 2025-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (39)

Institute for Liver Health; 🇺🇸 Chandler, Arizona, United States

Banner University Medical Center; 🇺🇸 Phoenix, Arizona, United States

Mayo Clinic; 🇺🇸 Phoenix, Arizona, United States

University of Arkansas; 🇺🇸 Little Rock, Arkansas, United States

Stanford University Medical Center; 🇺🇸 Palo Alto, California, United States

California Liver Research Institute; 🇺🇸 Pasadena, California, United States

University of California Davis; 🇺🇸 Sacramento, California, United States

University of Colorado- Anschutz Medical Campus; 🇺🇸 Aurora, Colorado, United States

Yale Internal Medicine, Digestive Diseases; 🇺🇸 New Haven, Connecticut, United States

Gastro Florida; 🇺🇸 Clearwater, Florida, United States

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