An observational study in Primary Biliary Cholangitis (PBC), sponsored by Ipsen. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-30.
Sponsored by Ipsen · Observational
The purpose of this study is to understand how tiredness changes in adults with Primary Biliary Cholangitis (PBC) after starting elafibranor in routine clinical practice.
PBC is a rare liver disease that damages the small bile ducts in the liver.
Participants will complete questionnaires before starting elafibranor and at Months 3, 6 and 12. The questionnaires will ask about tiredness, itching, work and daily activities. Each participant will be followed for approximately 12 months.
214 studies on the registry are indexed under Liver Cirrhosis, Biliary; 48 are open to participants now.
This study's planned enrollment of 50 is below the median of 380 across 54 observational studies indexed under Liver Cirrhosis, Biliary.
Browse Liver Cirrhosis, Biliary studies →Ipsen is the lead sponsor of 289 studies on the registry; 17 are open to participants now.
Of its 26 completed or terminated interventional studies of FDA-regulated products, 22 (85%) have results posted.
Counted across the registry records on this site, refreshed daily.
The participants of this study will be adult participants in the United States with a documented diagnosis of PBC who are newly initiating elafibranor in routine clinical practice
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Initial Screening Criteria (self-report)
Full Enrollment Criteria (confirmed via medical record review)
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Elafibranor
Elafibranor prescribed in routine clinical practice. Treatment is not assigned or provided by the study.
Change From Baseline in PBC-40 Fatigue Domain Score
The PBC-40 Fatigue Domain assesses fatigue and its impact on daily functioning in participants with primary biliary cholangitis. Higher scores indicate greater fatigue burden.
Time frame: Baseline and Months 3, 6 and 12
Change From Baseline in PROMIS Fatigue Short Form 7a Score
The PROMIS Fatigue Short Form 7a is a 7-item participant-reported questionnaire assessing the frequency, severity and impact of fatigue during the past 7 days. Higher T-scores indicate greater fatigue.
Time frame: Baseline and Months 3, 6 and 12
Baseline Age of Participants
Time frame: Baseline
Number of Participants by Sex
Time frame: Baseline
Number of Participants by Race
Time frame: Baseline
Number of Participants by Ethnicity
Time frame: Baseline
Number of Participants by Geographic Location
Time frame: Baseline
Time Since Primary Biliary Cholangitis Diagnosis
Time frame: Baseline
Number of Participants by Primary Biliary Cholangitis Disease Severity
Time frame: Baseline
Baseline Alkaline Phosphatase Level
Time frame: Baseline
Baseline Alanine Aminotransferase Level
Time frame: Baseline
Baseline Aspartate Aminotransferase Level
Time frame: Baseline
Baseline Total Bilirubin Level
Time frame: Baseline
Number of Participants by Primary Biliary Cholangitis-related Medication History
Time frame: Baseline
Change From Baseline in WPAI-SHP Absenteeism Score
The Work Productivity and Activity Impairment-Specific Health Problem (WPAI-SHP) absenteeism domain assesses work time missed because of primary biliary cholangitis during the past 7 days. Higher scores indicate greater work impairment.
Time frame: Baseline and Months 3, 6 and 12
Change From Baseline in WPAI-SHP Presenteeism Score
The WPAI-SHP presenteeism domain assesses impairment while working because of primary biliary cholangitis during the past 7 days. Higher scores indicate greater work impairment.
Time frame: Baseline and Months 3, 6 and 12
Change From Baseline in WPAI-SHP Overall Work Impairment Score
The WPAI-SHP overall work impairment domain assesses the combined impact of absenteeism and impairment while working because of primary biliary cholangitis during the past 7 days. Higher scores indicate greater work impairment.
Time frame: Baseline and Months 3, 6 and 12
Change From Baseline in WPAI-SHP Activity Impairment Score
The WPAI-SHP activity impairment domain assesses impairment in regular daily activities, other than paid work, because of primary biliary cholangitis during the past 7 days. Higher scores indicate greater activity impairment.
Time frame: Baseline and Months 3, 6 and 12
Change From Baseline in PBC-40 Emotional Domain Score
The Primary Biliary Cholangitis 40-item questionnaire (PBC-40) Emotional Domain assesses the emotional impact of primary biliary cholangitis. Higher scores indicate greater impairment.
Time frame: Baseline and Months 3, 6 and 12
Change From Baseline in PBC-40 Social Domain Score
The PBC-40 Social Domain assesses the impact of primary biliary cholangitis on social functioning and daily life. Higher scores indicate greater impairment.
Time frame: Baseline and Months 3, 6 and 12
Change From Baseline in PBC-40 Cognitive Domain Score
The PBC-40 Cognitive Domain assesses the impact of primary biliary cholangitis on memory, concentration and cognitive functioning. Higher scores indicate greater impairment.
Time frame: Baseline and Months 3, 6 and 12
Change From Baseline in PBC-40 General Symptoms Domain Score
The PBC-40 General Symptoms Domain assesses general symptoms associated with primary biliary cholangitis. Higher scores indicate greater symptom burden.
Time frame: Baseline and Months 3, 6 and 12
Change From Baseline in PBC-40 Itch Domain Score
The PBC-40 Itch Domain assesses the impact of itching associated with primary biliary cholangitis. Higher scores indicate greater itch burden.
Time frame: Baseline and Months 3, 6 and 12
Change From Baseline in Worst Itch Numeric Rating Scale (WI-NRS) Score
The Worst Itch Numeric Rating Scale assesses the intensity of the worst itching experienced during the past 7 days on a scale from 0 to 10, where 0 indicates no itching and 10 indicates the worst itching imaginable. Higher scores indicate greater itch severity.
Time frame: Baseline and Months 3, 6 and 12
No study locations are listed for this record.
Plan to share: Yes — Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of study participants.
Time frame: Where applicable, data from eligible studies are available 6 months after the studied medicine and indication have been approved in the US and/or EU.
Access criteria: Further details on Ipsen's sharing criteria and process for sharing are available here (https://www.ipsen.com/science/clinical-trials/clinical-data-transparency/).
Data sharing details ↗ · www.ipsen.com
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Aug 2028, 21 months later.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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