TARGET-PBC: A 5-year Longitudinal Observational Study of Patients with Primary Biliary Cholangitis

  • STATUS
    Recruiting
  • participants needed
    180
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Updated on 19 February 2024

Summary

You are being asked to be in this research study because you have PBC (primary biliary cholangitis) which is an uncommon chronic cholestatic liver disease characterized by progressive inflammation and destruction of the interlobular bile ducts, ultimately leading to the development of biliary cirrhosis. 

Description

The goals of this study are to collect information on patients with PBC to determine the natural course of the liver disease and to determine if certain lifestyle changes or changes in diet or other treatments that may be recommended by your doctors can affect “PBC.”. Currently, there are 2 specific drugs, Ocaliva™ and ursodeoxycholic acid (UDCA), approved by the FDA (the Food and Drug Administration to treat PBC. 

This research study aims to observe any treatment for PBC in a large number of people in a “real life” setting. Researchers are interested in observing how these treatments, lifestyle changes, and counseling work in patients who are treated by their doctors in routine practice. 

FAQ

This is an observational study. This means that none of the procedures that are regularly done in order to treat and monitor your PBC are changed by this observational study. Participating in this study does not change anything that your physician will do or has already done. Decisions about the types of therapies, length (duration), and dosing are determined by you and your physician and not affected by your participation in this study.

Details
Condition PBC,liver disease,primary billary Cholangitis
Age 18years - 80years
Clinical Study Identifier02932449
Last Modified on19 February 2024

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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