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New study tracks Real-World safety of odevixibat in rare liver disease

NCT ID NCT07585097

Disease control Sponsor: Ipsen Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 6 times

Summary

This study will follow 30 people with Alagille syndrome who are taking odevixibat in their daily lives. The goal is to see how safe the drug is over the long term by tracking any side effects. It is not testing if the drug works, but rather monitoring its real-world safety.

What this could mean

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

Active substance
odevixibat
What this could lead to
If successful, this study will confirm that odevixibat is safe for long-term use in Alagille syndrome, supporting its continued use to control symptoms.
What could go wrong
This is an observational study, not a treatment trial. It only monitors safety, not effectiveness. Side effects like diarrhea may still occur.

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.

Participants

About 30 people

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

Started

Jul 2026

Expected to finish

Sep 2031

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.

Who is studied

Participants with Alagille syndrome (ALGS) who have been prescribed odevixibat by their treating physician will be enrolled into the study. Participants who started odevixibat treatment before study implementation may also be enrolled.

Ages

6 months and older

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: * Diagnosed with ALGS. * On (or starting) active odevixibat treatment. * Aged 6 months or older at the time of consent. Exclusion Criteria: * Currently participating in a clinical trial with odevixibat. * Currently participating in any interventional clinical trial for ALGS. * Have any contraindication to odevixibat as per the locally approved label.

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Conditions

The condition(s) this trial relates to.

Alagille syndrome

As listed by the trial registrant

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

Alagille syndrome

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    14 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • A.O.U. Citta della Salute e della Scienza di Torino - Ospedale Infantile Regina Margherita

    NOT_YET_RECRUITING

    Torino, Italy

  • APHM - CHU Timone

    NOT_YET_RECRUITING

    Marseille, France

  • APHP - Centre Hepato-Biliaire Hospital Paul Brousse

    NOT_YET_RECRUITING

    Villejuif, France

  • APHP - Hopital Bicetre - Paris Sud

    NOT_YET_RECRUITING

    Le Kremlin-Bicêtre, France

  • APHP - Hopital Necker-Enfants Malades

    NOT_YET_RECRUITING

    Paris, France

  • Azienda Ospedaliera Di Rilievo Nazionale Santobono Pausilipon

    NOT_YET_RECRUITING

    Naples, Italy

  • Azienda Ospedaliero Universitaria Meyer

    RECRUITING

    Florence, Italy

  • CHU Dijon Bourgogne

    NOT_YET_RECRUITING

    Dijon, France

  • CHU de Montpellier - Hopital Saint Eloi

    NOT_YET_RECRUITING

    Montpellier, France

  • CHU de Toulouse - Hopital Paule de Viguier

    NOT_YET_RECRUITING

    Toulouse, France

  • Hospices Civils de Lyon - Hopital Femme Mere Enfant

    NOT_YET_RECRUITING

    Bron, France

  • IRCCS Ospedale Pediatrico Bambino Gesu

    NOT_YET_RECRUITING

    Roma, Italy

  • Ospedale Universitario Di Udine

    NOT_YET_RECRUITING

    Udine, Italy

  • University Hospital Of Padova

    NOT_YET_RECRUITING

    Padova, Italy

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