Elafribanor in Patients With Primary Biliary Cholangitis Receiving Treatment in a Real- World Setting

What is the Purpose of this Study?

The purpose of this study is to gain insight into the safety and effectiveness of a drug called elafibranor for the treatment of primary biliary cholangitis (PBC) in a real-world (routine care) setting. PBC is a chronic condition in which the bile ducts of the liver become damaged. Study procedures include questionnaires and collection of medical charts data. Researchers will also collect data from the patient’s caregiver to better understand how treatment with elafibranor impacts the caregiver financially, physically, and psychologically. For this study, a caregiver is defined as a non-paid, adult care person or family member in contact with the patient in daily life. Elafibranor has recently been approved by the U.S. Food and Drug Administration (FDA) for marketing based on the results of previous studies, which showed the drug’s effectiveness and safety for the treatment of PBC.


Eligibility

  • * Participant has provided written informed consent and agrees to comply with the study protocol.
  • * Participant with PBC diagnosis.
  • * Participant naïve to elafibranor, for whom the treating physician has decided to start treatment with elafibranor.
  • * If a participant has a caregiver who agrees to complete the caregiver questionnaires, an informed consent should be collected from the caregiver before any data is collected.
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Where can I participate?

Beverly

More about this Clinical Trial

What is the full name of this clinical trial?

PROSPECTIVE NON-INTERVENTIONAL, PHASE IV MULTICENTRE STUDY TO ASSESS THE EFFECTIVENESS, SAFETY AND TOLERABILITY OF ELAFIBRANOR 80 MG/DAY IN PATIENTS WITH PRIMARY BILIARY CHOLANGITIS RECEIVING TREATMENT IN A REAL-WORLD SETTING

Study Details
Disease Type/Condition

Other

Principal Investigator

Ayoub, Walid

Co-Investigators

Hirsh Trivedi

Age Group

Adult

Phase

IV

IRB Number

STUDY00003854

ClinicalTrials.gov ID

NCT06447168

Key Eligibility
ClinicalTrials.gov

How do I learn more about this study?
Email
clinicaltrials@cshs.org
Study Detail
Disease Type/Condition

Other

Principal Investigator

Ayoub, Walid

Age Group

Adult

Phase

IV

IRB Number

NIS-CLIN-60190-461

ClinicalTrials.gov ID

NCT06447168

Key Eligibility
ClinicalTrials.gov

Contact
Email
clinicaltrials@cshs.org