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New drug may help kids with rare liver disease avoid transplant

NCT ID NCT05426733

Disease control Sponsor: Albireo, an Ipsen Company Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Sep 01, 2026 · Updated 4 times

Summary

This study tests a drug called odevixibat in 180 children with biliary atresia, a rare liver disease. The goal is to see if the drug helps children stay alive without needing a liver transplant over the long term. Children who completed a previous study can join this open-label extension, meaning everyone gets the drug.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
odevixibat (a drug that blocks bile acid absorption in the gut)
What this could lead to
If it works, this could help children with biliary atresia avoid needing a liver transplant for longer.
What could go wrong
This is an extension study, so it builds on earlier results. The drug may not prevent transplant in all children, and side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 180 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2022

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Completion of the 104-week Treatment Period of Study A4250-011 * Signed informed consent by caregiver Exclusion Criteria: * Patients who were not compliant with study drug treatment or procedures in Study A4250-011 as per the investigator's discretion * Any conditions or abnormalities which, in the opinion of the investigator, may compromise the safety of the patient, or interfere with the patient participating in or completing the study * Known hypersensitivity to any components of odevixibat * Patients who are scheduled for a liver transplant or are likely to require a liver transplant in the immediate future based on the investigator's judgment

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Conditions

The condition(s) this trial relates to.

biliary atresia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Biliary atresia

Contacts and locations

Locations

  • ASST Papa Giovanni XXIII

    Bergamo, Italy

  • Akdeniz University Medical Faculty

    Antalya, Turkey (Türkiye)

  • Azienda Ospedaliera di Padova

    Padova, Italy

  • Bicêtre Hospital

    Le Kremlin-Bicêtre, France

  • Boston Children's Hospital

    Boston, Massachusetts, 02115, United States

  • CHU Sainte-Justine

    Montreal, Canada

  • Charité - Universitätsmedizin Berlin

    Berlin, Germany

  • Children's Healhcare of Atlanta- Emory University school of medicine

    Atlanta, Georgia, 30322, United States

  • Children's Hospital Colorado

    Aurora, Colorado, 80045, United States

  • Children's Hospital of Fudan University

    Shanghai, China

  • Children's Mercy Hospital and Clinics

    Kansas City, Missouri, 64108, United States

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229, United States

  • Columbia University Medical Center New York Presbyterian Morgan Stanley-Komansky Childrens Hospital

    New York, New York, 10032, United States

  • Guangzhou Women And Childrens Medical Center

    Guangdong, China

  • Hacettepe İhsan Doğramacı Children's Hospital

    Ankara, Turkey (Türkiye)

  • Hassenfeld Children's Hospital at NYU Langone

    New York, New York, 10016, United States

  • Hospital Raja Perempuan Zainab II

    Kota Bharu, Malaysia

  • Hospital Universitari Vall d'Hebron

    Barcelona, Spain

  • Indiana University school of Medicine

    Indianapolis, Indiana, 46202, United States

  • Instytut Pomnik-Centrum Zdrowia Dziecka

    Warsaw, Poland

  • Istanbul University Istanbul Medical Faculty Hospital

    Istanbul, Turkey (Türkiye)

  • Royal Children's Hospital

    Parkville, 3052, Australia

  • Seattle Children's Hospital

    Seattle, Washington, 98105, United States

  • Seoul National University Childrens Hospital

    Seoul, South Korea

  • Starship Child Health, Te Whatu Ora - Health New Zealand

    Auckland, 1023, New Zealand

  • The Childrens Hospital at Montefiore Albert Einstein School of Medicine

    The Bronx, New York, 10467, United States

  • The Hospital for Sick Children

    Toronto, Canada

  • University Children´s Hospital Tuebingen

    Tübingen, Germany

  • University Malaya Medical Centre

    Kuala Lumpur, 59100, Malaysia

  • University Medical Center Groningen

    Groningen, Netherlands

More trials for these conditions

Other studies related to the condition(s) this trial covers.