This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback
Trial record 1 of 1 for:    Target-PBC
Previous Study | Return to List | Next Study

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

This study is currently recruiting participants.
See Contacts and Locations
Verified June 2017 by Target PharmaSolutions, Inc.
Sponsor:
Information provided by (Responsible Party):
Target PharmaSolutions, Inc.
ClinicalTrials.gov Identifier:
NCT02932449
First received: September 7, 2016
Last updated: June 13, 2017
Last verified: June 2017
  Purpose
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.

Condition
Biliary Cirrhosis, Primary

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Other
Official Title: A 5-year Longitudinal Observational Study of Patients With Primary Biliary Cholangitis

Resource links provided by NLM:


Further study details as provided by Target PharmaSolutions, Inc.:

Primary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples With DNA

Participants enrolled in TARGET-PBC will be invited to participate in the optional Biorepository Specimen Bank (BSB). Blood samples for biomarker and DNA/RNA assays will be collected on a voluntary basis and participation in this project will not affect participation in the main study.

Blood samples for exploratory genetic and biomarker studies can be used for research purposes to identify potential biomarkers predictive of PBC diagnosis, assess correlates of response to PBC treatment (in terms of mode of action, efficacy, dose, safety and tolerability), understand factors influencing disease progression, determine how best to monitor and treat PBC, aid in the development of a new medical products, or explore complications of PBC and treatment.


Estimated Enrollment: 1500
Study Start Date: October 2016
Estimated Study Completion Date: September 2021
Estimated Primary Completion Date: September 2021 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
adults with PBC who are being seen specifically to address this disease process
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02932449

Contacts
Contact: Karen Deane 984-234-0268 kdeane@targetpharmasolutions.com

Locations
United States, Arizona
Mayo Clinic Recruiting
Phoenix, Arizona, United States, 85054
Contact: Alicia Rankin    480-342-1258    rankin.alicia@mayo.edu   
United States, Florida
Gastro Florida Recruiting
Clearwater, Florida, United States, 33762
Contact: Shannon Brewington, CRC    727-336-7682    sbrewington@gastrofl.com   
University of Florida Hepatology Research Recruiting
Gainesville, Florida, United States, 32610
Contact: Angie Bauer    352-273-9512    bauera@medicine.ufl.edu   
SCFLD/University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Claudia Cottone    305-243-1104    cxc1335@med.miami.edu   
United States, Illinois
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Elie Ghoulam    312-563-7522    Elie_Ghoulam@rush.edu   
United States, Maryland
Mercy Medical Center, GI Research Recruiting
Baltimore, Maryland, United States, 21202
Contact: Polly Robarts    410-843-2075    probarts@mdmercy.com   
United States, Missouri
Saint Louis University Recruiting
Saint Louis, Missouri, United States, 63104
Contact: Alisha McClendon    314-977-9409    mcclendona@slu.edu   
United States, Nebraska
University of Nebraska Recruiting
Omaha, Nebraska, United States, 68106
Contact: Amanda Fletcher    402-552-6120    amanda.fletcher@unmc.edu   
United States, New York
Sandra Atlas Bass Center for Liver Diseases Recruiting
Manhasset, New York, United States, 11030
Contact: Radica Palmer, NP    516-562-2082    rpalmer@northwell.edu   
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Cristina Falo    212-305-3839    cf2427@cumc.columbia.edu   
United States, North Carolina
University of North Carolina at Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Renee T. Blanchard, CCRC    919-843-5936    renee_Blanchard@med.unc.edu   
Center for Liver Disease and Transplant at CMC Recruiting
Charlotte, North Carolina, United States, 28204
Contact: Gale Groseclose    704-355-4875    gale.groseclose@carolinashealthcare.org   
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Maureen McCauley    215-746-2575    maureen.mccauley2@uphs.upenn.edu   
United States, Texas
Pinnacle Clinical Research Terminated
Live Oak, Texas, United States, 78233
United States, Virginia
Bon Secours Liver Institute of Virginia Recruiting
Richmond, Virginia, United States, 23226
Contact: Joyce Soublet, LPN    757-947-3190    joyce_soublet@bshsi.org   
United States, Washington
University of Washington Recruiting
Seattle, Washington, United States, 98104
Contact: Peter Nguyen    206-744-3402    phnmedic@uw.edu   
Sponsors and Collaborators
Target PharmaSolutions, Inc.
  More Information

Responsible Party: Target PharmaSolutions, Inc.
ClinicalTrials.gov Identifier: NCT02932449     History of Changes
Other Study ID Numbers: TARGET-PBC
Study First Received: September 7, 2016
Last Updated: June 13, 2017
Individual Participant Data  
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Cholangitis
Liver Cirrhosis, Biliary
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Cholestasis, Intrahepatic
Cholestasis
Liver Diseases
Liver Cirrhosis

ClinicalTrials.gov processed this record on June 23, 2017