This study will collect information from participants with Primary Biliary Cholangitis (PBC) as they use the drug elafibranor in real world setting.
PBC is a progressive rare liver disease in which tubes in the liver called bile ducts are damaged.
The liver damage in PBC may lead to scarring (cirrhosis). PBC may also be associated with multiple symptoms including pruritus (itching) and fatigue. Many patients with PBC may require liver transplant or may die if the disease progresses and a liver transplant is not done.
In this study the main aim is to observe the effectiveness, safety and tolerability of elafibranor in participants with PBC who are receiving treatment in real world setting. The total study duration for each participants will be 60 months (approximately 5 years).
Participant has provided written informed consent and agrees to comply with the study protocol.
Participant with PBC diagnosis.
Participant for whom the treating physician has decided to start or participants who are currently receiving treatment with commercialized 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.
Participant is currently participating or, plans to participate in an investigational drug study or medical device study containing active substance.
Participant with known hypersensitivity to the product or to any of its excipients.
Participant with mental instability or incompetence, such that the validity of informed consent or ability to be compliant with the study is uncertain.
Participants with PBC for whom the treating physician has decided to start treatment with elafibranor 80 mg/day, as recommended in the approved indication.
Cohort
Prospective
Not listed
Percentage of participants with response to treatment
Defined as alkaline phosphatase (ALP) \<1.67 x upper limit of normal (ULN) and total bilirubin (TB) ≤ULN and ALP decrease ≥15% from baseline.
Percentage of participants with normalization of ALP levels
Percentage of participants with response to treatment
Defined as ALP\<1.67 x ULN and TB≤ULN and ALP decrease ≥15% from baseline.
Change from baseline in liver function parameters: Serum levels of alanine aminotransferase (ALT)
Change from baseline in liver function parameters: Serum levels of Aspartate aminotransferase (AST)