A Study Observing Everyday Effectiveness and Safety of the Drug Elafibranor in Participants With Primary Biliary Cholangitis Who Are Receiving Ongoing Treatment

Percentage of participants with normalization of ALP levels

Time frame: Up to 60 months following enrollment, based on routine physician follow-up visit

Percentage of participants with response to treatment

Defined as ALP\<1.67 x ULN and TB≤ULN and ALP decrease ≥15% from baseline.

Time frame: Up to 60 months following enrollment, based on routine physician follow-up visits

Change from baseline in liver function parameters: Serum levels of alanine aminotransferase (ALT)

Time frame: Up to 60 months following enrollment, based on routine physician follow-up visit

Change from baseline in liver function parameters: Serum levels of Aspartate aminotransferase (AST)

Time frame: Up to 60 months following enrollment, based on routine physician follow-up visit

Change from baseline in liver function parameters: Serum levels of Gamma-glutamyl transferase (GGT)

Time frame: Up to 60 months following enrollment, based on routine physician follow-up visit

Change from baseline in liver function parameters: Serum levels of TB

Time frame: Up to 60 months following enrollment, based on routine physician follow-up visit

Change from baseline in liver function parameters: Conjugated (direct) bilirubin

Time frame: Up to 60 months following enrollment, based on routine physician follow-up visit

Change from baseline in liver function parameters: Serum levels of creatinine

Time frame: Up to 60 months following enrollment, based on routine physician follow-up visit

Change from baseline in liver function parameters: Serum levels of albumin

Time frame: Up to 60 months following enrollment, based on routine physician follow-up visit

Change from baseline in pruritus based on PBC Itch score

The PBC Itch score is a simple, self-administered Patient Reported Outcome (PRO) questionnaire that measures itch intensity. It uses 7-day recall periods and asks participants to rate the intensity of their worst itch over the past 7-day period on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable).

Time frame: Up to 60 months following enrollment, based on routine physician follow-up visit

Change from baseline in fatigue based on functional assessment of chronic illness therapy-fatigue (FACIT-Fatigue) scale

The FACIT-Fatigue is a 13-item measure that assesses self-reported fatigue and its impact upon daily activities and function. It is a subset of the longer (47-item) Functional Assessment of Cancer Therapy - Anemia (FACT-An), which includes the 27-item FACT-G and a 20-item subscale addressing additional concerns associated with the anemia of cancer and its treatment. This 20-item subscale, referred to as the anemia subscale, is comprised of 13-items that assess fatigue and its impact (the FACIT-Fatigue) and, 7 additional symptoms associated with anemia (e.g. shortness of breath, headache). participants rate their symptoms over the preceding seven days on a verbal response scale, the options range from 'not at all' / 'a little bit' / 'somewhat quite a bit' / very much'.

Time frame: Up to 60 months following enrollment, based on routine physician follow-up visit

Change from baseline in sleep based on Pittsburgh sleep quality index (PSQI)

The PSQI was designed to evaluate overall sleep quality in the psychiatric disorders associated with sleep disturbances. Each of the questionnaire's 19-self-reported items belongs to one of seven subcategories: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. Five additional questions rated by the respondent's roommate or bed partner are included for clinical purposes and are not scored.

Time frame: Up to 60 months following enrollment, based on routine physician follow-up visit

Change from baseline in Quality Of Life (QoL) based on PBC-40 questionnaire

The PBC-40 is a validated, PBC-specific, health-related Quality Of Life (QoL) questionnaire with 40 questions that assesses symptoms across six domains: fatigue, emotional and social, cognitive function, general symptoms and itch. Participants respond on a verbal response scale, depending on the section options range from 'never' / 'not at all' / 'strongly disagree' to 'always' / 'very much'/ 'strongly agree'. Five items (3/3 in the itch domain and 2/10 in the social domain) also include a 'does not apply' option. A score for each domain is provided (but a total score is not calculated), with each verbal response scale correlating to a score of 1-5 per item (0-5 on items with a 'does not apply' option) with 5 being the most affected.

Time frame: Up to 60 months following enrollment, based on routine physician follow-up visit

Change from baseline in QoL based on 5-Dimensional Itch scale (5-D Itch, also known as 5-D pruritus scale)

The 5-D Itch scale assesses symptoms in terms of five domains: degree, duration, direction, disability and distribution. It is a 1 to 5 scale, with 5 being the most affected.

Time frame: Up to 60 months following enrollment, based on routine physician follow-up visit

Change from baseline in liver stiffness

Measured by transient elastography (FibroScan®) and enhanced liver fibrosis (ELF) test

Time frame: Up to 60 months following enrollment, based on routine physician follow-up visit

Event free survival

Event free survival from first intake of commercialized elafibranor treatment as prescribed by physician to the first occurrence of any of the following clinical outcome events: (1) death, (2) liver transplant, and (3) liver decompensation.

Time frame: From baseline to up to 60 months

Percentage of participants experiencing Adverse Events (AEs), Adverse Events of Special Interests (AESIs) and special situations (SS).

An Adverse event (AE) is any untoward medical occurrence, temporally associated with the use of study intervention, whether or not related to the study intervention. AESIs are AEs that may not be serious but are of special importance to a particular drug or class of drugs.

Time frame: From baseline to up to 60 months

Participant's satisfaction on treatment

Measured by treatment satisfaction questionnaire for medication (TSQM). The TSQM (version 1.4) has 14 questions divided into 4 subscales: effectiveness (items 1 to 3), side effects (items 4 to 8), convenience (items 9 to 11), and global satisfaction (items 12 to 14).

Time frame: Up to 60 months following enrollment, based on routine physician follow-up visit

Participant's adherence to treatment

Adherence to the treatment will be measured based on the participant report of missed doses every month.

Time frame: Up to 60 months following enrollment, based on routine physician follow-up visit

Percentage of participants with clinically significant changes in laboratory parameters

Percentage of participants with clinically significant change in laboratory parameters (blood chemistry, hematology and coagulation) will be reported. The clinical significance will be graded by the investigator.

Time frame: Up to 60 months following enrollment, based on routine physician follow-up visit

Percentage of participants with clinically significant changes in physical examination

Clinically significant changes in physical examination will be reported. The clinical significance will be graded by the investigator.

Time frame: Up to 60 months following enrollment, based on routine physician follow-up visit

Percentage of participants developing clinically significant changes in vital signs

Clinically significant changes in vital signs will be reported. The clinical significance will be graded by the investigator.

Time frame: Up to 60 months following enrollment, based on routine physician follow-up visit