Primary Biliary Cholangitis Trial, Recruiting (NCT06447168)

Primary Biliary Cholangitis Trial, Recruiting NCT06447168 Sponsor: Ipsen Condition: Primary Biliary Cholangitis

Printed from Voxsanity (voxsanity.com.au) — NCT06447168 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.

Back to Primary Biliary Cholangitis

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

You have agreed in writing to take part and are willing to follow the study's rules and procedures.
You have been diagnosed with PBC (Primary Biliary Cholangitis), a condition affecting the liver.
Your doctor has decided you should start taking a medication called elafibranor, or you are already taking it.
If you have a caregiver who is willing to fill out some questionnaires as part of the study, they must also give their written agreement before any information is collected from them.

Who may not be able to join:

You are currently taking part in, or are planning to join, another clinical trial that involves an experimental drug or medical device.
You have a known allergy or sensitivity to elafibranor or any of its ingredients.
You have a mental health condition or difficulty that may make it hard to fully understand and agree to take part, or to follow the study requirements (confirm with trial site).

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.

Last synced 28 July 2026

This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Ipsen Medical Director, Ipsen

Phone: See e mail

Australian sites

St Vincent's Hospital, Fitzroy,

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Voxsanity

Clinical trials and treatments, explained plainly · voxsanity.com.au

Date:

To: My Doctor

Re: Clinical trial enquiry

I am writing to enquire about the following clinical trial which may be relevant to my care:

Trial: NCT06447168

Sponsor: Ipsen

Phase: Not Applicable

Status: Recruiting

Condition: Primary Biliary Cholangitis

Trial contact: See e mail

More information: https://clinicaltrials.gov/study/NCT06447168

Eligibility summary (AI generated)

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

You have agreed in writing to take part and are willing to follow the study's rules and procedures.
You have been diagnosed with PBC (Primary Biliary Cholangitis), a condition affecting the liver.
Your doctor has decided you should start taking a medication called elafibranor, or you are already taking it.
If you have a caregiver who is willing to fill out some questionnaires as part of the study, they must also give their written agreement before any information is collected from them.

Who may not be able to join:

You are currently taking part in, or are planning to join, another clinical trial that involves an experimental drug or medical device.
You have a known allergy or sensitivity to elafibranor or any of its ingredients.
You have a mental health condition or difficulty that may make it hard to fully understand and agree to take part, or to follow the study requirements (confirm with trial site).

Important: Always verify eligibility with the trial site directly before applying.

Access in Australia: A treatment being studied in a clinical trial is generally not yet listed on the PBS. Where a medicine is not approved or not available through a trial, the TGA Special Access Scheme may allow a doctor to access unapproved therapeutic goods for individual patients. See voxsanity.com.au/sas-navigator/ for a plain English explainer.

This information was sourced from ClinicalTrials.gov via Voxsanity (data last synced 28 July 2026). It is not medical advice. Please verify the trial's current status directly with the trial site before acting.

Trial details

Status

Recruiting

Phase

Not Applicable

Sponsor

Ipsen

Registry

ClinicalTrials.gov

Start date

14 October 2024

Est. completion

15 July 2032

Where this trial is recruiting

🇦🇺 Australia 🇦🇹 Austria 🇨🇦 Canada 🇩🇪 Germany 🇬🇷 Greece 🇮🇹 Italy 🇪🇸 Spain 🇦🇪 United Arab Emirates 🇬🇧 United Kingdom 🇺🇸 United States

1 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Percentage of participants with response to treatment

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov