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

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ClinicalTrials.gov Identifier: NCT02932449
Recruitment Status : Active, not recruiting
First Posted : October 13, 2016
Last Update Posted : March 11, 2021
Sponsor:
Information provided by (Responsible Party):
Target PharmaSolutions, Inc.

Study Description
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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.

Condition or disease
Biliary Cirrhosis, Primary

Study Design
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Study Type : Observational
Estimated Enrollment : 1500 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: A 5-year Longitudinal Observational Study of Patients With Primary Biliary Cholangitis
Study Start Date : October 2016
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021

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Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Evaluate PBC treatment regimens being used in clinical practice [ Time Frame: up to 5 years ]
  2. Examine populations underrepresented in phase III clinical trials [ Time Frame: up to 5 years ]
  3. Examine biochemical response and its association with long term outcomes [ Time Frame: up to 5 years ]
  4. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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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


Locations
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Sponsors and Collaborators
Target PharmaSolutions, Inc.
More Information
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Responsible Party: Target PharmaSolutions, Inc.
ClinicalTrials.gov Identifier: NCT02932449    
Other Study ID Numbers: TARGET-PBC
First Posted: October 13, 2016    Key Record Dates
Last Update Posted: March 11, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Cholangitis
Liver Cirrhosis, Biliary
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
 Cholestasis, Intrahepatic
Cholestasis
Liver Diseases
Liver Cirrhosis