Clinical trial NCT02932449: A 5-year Longitudinal Observational Study of Patients With Primary Biliary Cholangitis
Official title: A 5-year Longitudinal Observational Study of Patients With Primary Biliary Cholangitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Biliary Cirrhosis, Primary
Lead sponsor: Target PharmaSolutions, Inc.
Sponsor class: INDUSTRY
First posted: 2016-10-13
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adults with PBC who are being seen specifically to address this disease process

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.


Eligibility criteria: 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

Primary outcomes:
measure: Evaluate PBC treatment regimens being used in clinical practice
timeFrame: up to 5 years
measure: Examine populations underrepresented in phase III clinical trials
timeFrame: up to 5 years
measure: Examine biochemical response and its association with long term outcomes
timeFrame: up to 5 years
measure: Estimate adverse event frequency and severity and describe management practices
timeFrame: up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Institute for Liver Health
state: Arizona
city: Phoenix
country: United States
facility: Banner University Medical Center
state: Arizona
city: Phoenix
country: United States
facility: Mayo Clinic
state: Arizona
city: Little Rock
country: United States
facility: University of Arkansas
state: Arkansas
city: Palo Alto
country: United States
facility: Stanford University Medical Center
state: California
city: Pasadena
country: United States
facility: California Liver Research Institute
state: California
city: Sacramento
country: United States
facility: University of California Davis
state: California
city: Aurora
country: United States
facility: University of Colorado- Anschutz Medical Campus
state: Colorado
city: New Haven
country: United States
facility: Yale Internal Medicine, Digestive Diseases
state: Connecticut
city: Clearwater
country: United States
facility: Gastro Florida
state: Florida
city: Gainesville
country: United States
facility: University of Florida Hepatology Research
state: Florida
city: Miami
country: United States
facility: SCFLD/University of Miami
state: Florida
city: Atlanta
country: United States
facility: Piedmont Atlanta Hospital
state: Georgia
city: Arlington Heights
country: United States
facility: Illinois Gastroenterology Group
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Baltimore
country: United States
facility: Mercy Medical Center, GI Research
state: Maryland
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Jackson
country: United States
facility: Southern Therapy and Advanced Research LLC (STAR)
state: Mississippi
city: Saint Louis
country: United States
facility: Saint Louis University
state: Missouri
city: Omaha
country: United States
facility: University of Nebraska
state: Nebraska
city: Manhasset
country: United States
facility: Sandra Atlas Bass Center for Liver Diseases
state: New York
city: New York
country: United States
facility: NYU Langone Health
state: New York
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Charlotte
country: United States
facility: Center for Liver Disease and Transplant at CMC
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Columbus
country: United States
facility: Ohio State University Medical Center
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
city: Fort Worth
country: United States
facility: Baylor,Scott and White All Saints
state: Texas
city: Houston
country: United States
facility: Liver Associates of Texas, P.A.
state: Texas
city: Live Oak
country: United States
facility: Pinnacle Clinical Research
state: Texas
city: Richmond
country: United States
facility: Bon Secours Liver Institute of Virginia
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University (VCU)
state: Virginia
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
References: