A 5-year Longitudinal Observational Study of Patients With Primary Biliary Cholangitis
|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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02932449|
Recruitment Status : Active, not recruiting
First Posted : October 13, 2016
Last Update Posted : March 11, 2021
|Condition or disease|
|Biliary Cirrhosis, Primary|
|Study Type :||Observational|
|Estimated Enrollment :||1500 participants|
|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|
- 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.
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