Primary Biliary Cholangitis (PBC)NCT07906639
A Study of Fatigue, Itching and Daily Activities in People With Primary Biliary Cholangitis Starting Elafibranor
An observational study of Primary Biliary Cholangitis (PBC), run by Ipsen.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Biliary Cholangitis (PBC)
- What is being tested?
- Elafibranor
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 2 Nov 2026to 21 Aug 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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
Who may be able to join
- Initial Screening Criteria (self-report)
- Self-reported diagnosis of PBC.
- Age ≥18 years at the time of screening.
- Self-reported treatment plan to initiate elafibranor, with no prior dose received before screening.
- Completion of the PBC-40 Fatigue Domain at the time of screening.
- Stratified enrollment targets will be applied, see Section 5.2 (Enrollment Targets) for the target distribution and operational management.
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- Provided signed informed consent and medical record release authorization prior to data collection.
- Full Enrollment Criteria (confirmed via medical record review)
- Medical-record confirmed diagnosis of PBC.
- Documented prescription or treatment plan to initiate elafibranor and has not received a prior dose of elafibranor before enrollment.
Who cannot join
- Unable to read and/or self-complete electronic ePRO instruments or do not have a designee available to complete ePROs on their behalf.
- Do not have access to a device on which ePRO instruments can be completed.
- Self-reported participation in an interventional trial in PBC at the time of screening.
- Failure to complete required baseline ePRO assessments (PBC-40 and PROMIS Fatigue SF-7a).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Prospective Observational Study Assessing the Impact of Elafibranor on Fatigue, Work Productivity/Activity Impairment, and Pruritus in Patients With PBC
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.
- Conditions
- Primary Biliary Cholangitis (PBC)
- Being tested
- Elafibranor
- Keywords
- Rare disease, Primary Biliary Cholangitis
- Medical subject headings
- Liver Cirrhosis, Biliary, Rare Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElafibranorDrug
Elafibranor prescribed in routine clinical practice. Treatment is not assigned or provided by the study.
| Study group | Role | What they receive |
|---|---|---|
| Adults with PBC Starting Elafibranor | Not described Receives: Drug: Elafibranor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline and Months 3, 6 and 12
Secondary outcomes (22)
Baseline Age of Participants
Measured: Baseline
Number of Participants by Sex
Measured: Baseline
Number of Participants by Race
Measured: Baseline
Number of Participants by Ethnicity
Measured: Baseline
Number of Participants by Geographic Location
Measured: Baseline
Time Since Primary Biliary Cholangitis Diagnosis
Measured: Baseline
Number of Participants by Primary Biliary Cholangitis Disease Severity
Measured: Baseline
Baseline Alkaline Phosphatase Level
Measured: Baseline
Baseline Alanine Aminotransferase Level
Measured: Baseline
Baseline Aspartate Aminotransferase Level
Measured: Baseline
Baseline Total Bilirubin Level
Measured: Baseline
Number of Participants by Primary Biliary Cholangitis-related Medication History
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and Months 3, 6 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2026
- Study start2 Nov 2026 (estimated)
- Primary completion21 Aug 2028 (estimated)
- Study completion21 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Biliary Cholangitis (PBC)Studies of the same condition, open and under way.
- More trials run by IpsenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ipsen Medical Director, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07906639
- Sponsor's protocol ID
- CLIN-60190-477
- Status last verified
- Oct 2026
- First submitted
- 7 Oct 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study Assessing the Impact of Elafibranor on Fatigue, Work Productivity/Activity Impairment, and Pruritus in Patients With PBC
- ClinicalTrials.gov ID
- NCT07906639
- Acronym / sponsor ID
- CLIN-60190-477
- Conditions
- Primary Biliary Cholangitis (PBC)
- Keywords
- Rare disease, Primary Biliary Cholangitis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- 2 Nov 2026 (estimated)
- Primary completion
- 21 Aug 2028 (estimated)
- Study completion
- 21 Aug 2028 (estimated)
- First posted
- 30 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults with PBC Starting Elafibranor | – | Drug: Elafibranor |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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
Key inclusion criteria (10 listed)
- Initial Screening Criteria (self-report)
- Self-reported diagnosis of PBC.
- Age ≥18 years at the time of screening.
- Self-reported treatment plan to initiate elafibranor, with no prior dose received before screening.
- Completion of the PBC-40 Fatigue Domain at the time of screening.
Key exclusion criteria (4 listed)
- Unable to read and/or self-complete electronic ePRO instruments or do not have a designee available to complete ePROs on their behalf.
- Do not have access to a device on which ePRO instruments can be completed.
- Self-reported participation in an interventional trial in PBC at the time of screening.
- Failure to complete required baseline ePRO assessments (PBC-40 and PROMIS Fatigue SF-7a).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ElafibranorElafibranor prescribed in routine clinical practice. Treatment is not assigned or provided by the study. | Drug | Adults with PBC Starting Elafibranor |
Primary outcome
Change From Baseline in PBC-40 Fatigue Domain Score
Time frame: Baseline and Months 3, 6 and 12
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.
Change From Baseline in PROMIS Fatigue Short Form 7a Score
Time frame: Baseline and Months 3, 6 and 12
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.
22 secondary outcomes
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
Time frame: Baseline and Months 3, 6 and 12
Change From Baseline in WPAI-SHP Presenteeism Score
Time frame: Baseline and Months 3, 6 and 12
Change From Baseline in WPAI-SHP Overall Work Impairment Score
Time frame: Baseline and Months 3, 6 and 12
Change From Baseline in WPAI-SHP Activity Impairment Score
Time frame: Baseline and Months 3, 6 and 12
Change From Baseline in PBC-40 Emotional Domain Score
Time frame: Baseline and Months 3, 6 and 12
Change From Baseline in PBC-40 Social Domain Score
Time frame: Baseline and Months 3, 6 and 12
Change From Baseline in PBC-40 Cognitive Domain Score
Time frame: Baseline and Months 3, 6 and 12
Change From Baseline in PBC-40 General Symptoms Domain Score
Time frame: Baseline and Months 3, 6 and 12
Change From Baseline in PBC-40 Itch Domain Score
Time frame: Baseline and Months 3, 6 and 12
Change From Baseline in Worst Itch Numeric Rating Scale (WI-NRS) Score
Time frame: Baseline and Months 3, 6 and 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ipsen Medical Director study director
Ipsen
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Biliary Cholangitis (PBC), run by Ipsen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ipsen Clinical Study Enquiries (See e-mail, clinical.trials@ipsen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in PBC-40 Fatigue Domain Score (time frame: Baseline and Months 3, 6 and 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.