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

Biliary Cirrhosis, Primary Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02932449
• Other study ID #: TARGET-PBC
• Status: Active, not recruiting
• Start date: October 2016
• Est. completion date: September 2026

Study information

• Verified date: March 2024
• Source: Target PharmaSolutions, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1500
• Est. completion date: September 2026
• Est. primary completion date: September 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Biliary Cirrhosis, Primary
• Cholangitis
• Liver Cirrhosis, Biliary

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Illinois Gastroenterology Group	Arlington Heights	Illinois
United States	Piedmont Atlanta Hospital	Atlanta	Georgia
United States	University of Colorado- Anschutz Medical Campus	Aurora	Colorado
United States	Mercy Medical Center, GI Research	Baltimore	Maryland
United States	Institute for Liver Health	Chandler	Arizona
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	Center for Liver Disease and Transplant at CMC	Charlotte	North Carolina
United States	Rush University Medical Center	Chicago	Illinois
United States	University of Chicago	Chicago	Illinois
United States	Gastro Florida	Clearwater	Florida
United States	Ohio State University Medical Center	Columbus	Ohio
United States	UT Southwestern Medical Center	Dallas	Texas
United States	Duke University Medical Center	Durham	North Carolina
United States	Baylor,Scott and White All Saints	Fort Worth	Texas
United States	University of Florida Hepatology Research	Gainesville	Florida
United States	Liver Associates of Texas, P.A.	Houston	Texas
United States	University of Iowa	Iowa City	Iowa
United States	Southern Therapy and Advanced Research LLC (STAR)	Jackson	Mississippi
United States	University of Arkansas	Little Rock	Arkansas
United States	Pinnacle Clinical Research	Live Oak	Texas
United States	University of Wisconsin	Madison	Wisconsin
United States	Sandra Atlas Bass Center for Liver Diseases	Manhasset	New York
United States	SCFLD/University of Miami	Miami	Florida
United States	Yale Internal Medicine, Digestive Diseases	New Haven	Connecticut
United States	Columbia University Medical Center	New York	New York
United States	NYU Langone Health	New York	New York
United States	Weill Cornell Medical College	New York	New York
United States	University of Nebraska	Omaha	Nebraska
United States	Stanford University Medical Center	Palo Alto	California
United States	California Liver Research Institute	Pasadena	California
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Banner University Medical Center	Phoenix	Arizona
United States	Mayo Clinic	Phoenix	Arizona
United States	Bon Secours Liver Institute of Virginia	Richmond	Virginia
United States	Virginia Commonwealth University (VCU)	Richmond	Virginia
United States	University of California Davis	Sacramento	California
United States	Saint Louis University	Saint Louis	Missouri
United States	University of Washington	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Target PharmaSolutions, Inc.

Country where clinical trial is conducted

United States, 

Outcome

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