An observational study in Primary Biliary Cholangitis, sponsored by Ipsen. Active, not recruiting at 72 sites in 11 countries. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by Ipsen · Observational
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
Among 10 studies in Liver Cirrhosis, Biliary by Ipsen — 3 open to participants now, 6 under way, 3 of them phase 3. Liver Cirrhosis, Biliary · Ipsen.
Among the 10 studies in Liver Cirrhosis, Biliary by Ipsen, this one is one of 2 that started in 2024, is one of 4 observational ones, and was the 6th registered.
214 studies on the registry are indexed under Liver Cirrhosis, Biliary; 48 are open to participants now.
Browse Liver Cirrhosis, Biliary studies →3 of the 10 studies in Liver Cirrhosis, Biliary by Ipsen are open now, in 12 countries. Recruiting first, the newest first:
Ipsen · Sites in United States
Women only
Ipsen · Sites in United States, Argentina, Australia and 25 more countries
Ages 18+
Ipsen
Ages 18+
By country, each count listing its studies:
Of the 34 Liver Cirrhosis, Biliary studies recruiting now, 16 (47%) set no upper age limit and 11 (32%) stop at 75 or younger; 3 take children under 18; 4 take healthy volunteers.
This study: all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
10 studies; the count open now beside each. This study's row is marked.
First in 2013; this study’s year is marked. 2 started in 2024.
This study's planned enrollment of 424 is above the median of 380 across 54 observational studies indexed under Liver Cirrhosis, Biliary.
Median enrollment 93 across the 6 interventional studies, 40 across the 4 observational. Of the 4 that completed or were terminated, 0 (0%) have results posted.
This tab as a report to print or save as PDF → With an account.
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.
1 of the studies in Liver Cirrhosis, Biliary by Ipsen that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06730061Phase 3IpsenA Study of Elafibranor in Adult Japanese Participants With Primary Biliary Cholangitis (PBC) | 2026-12-17 |
Add it to your calendar (.ics) → With an account.
Among the 10 studies in Liver Cirrhosis, Biliary by Ipsen, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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).
Participants with PBC for whom the treating physician has decided to start treatment with elafibranor 80 mg/day, as recommended in the approved indication.
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.
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.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
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.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Time frame: At month 6
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
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.
Started Oct 2024 (actual). Primary completion is estimated for Jul 2032, 93 months after the start.
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 active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.