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Trial record 1 of 5 for:    target pbc
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A 5-year Longitudinal Observational Study of Patients With Primary Biliary Cholangitis

This study is currently recruiting participants.
Verified October 2017 by Target PharmaSolutions, Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02932449
First Posted: October 13, 2016
Last Update Posted: October 18, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Target PharmaSolutions, Inc.
  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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02932449


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

  Show 26 Study Locations
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
First Submitted: September 7, 2016
First Posted: October 13, 2016
Last Update Posted: October 18, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
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