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.
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