See if odevixibat stays safe for kids and adults with Alagille syndrome over the long term

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study will collect long-term safety data on odevixibat in patients with Alagille syndrome who are already receiving ongoing treatment. Participants aged 6 months or older will contribute information from their daily care to understand safety over time. The study does not involve a new intervention, randomization, or placebo, and follows patients in real-world clinical settings across multiple sites. It aims to identify any persistent or late-emerging safety signals and inform clinicians about longer-term tolerability. Eligible individuals must be diagnosed with ALGS and actively receiving or starting odevixibat, with exclusions for those in other interventional trials or with contraindications per local labeling.

Why it matters

Who can join: the full rules

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.

Where it's running

• Hospices Civils de Lyon - Hopital Femme Mere Enfant
  Bron, France Recruiting
• Azienda Ospedaliero Universitaria Meyer
  Florence, Italy Recruiting
• Azienda Ospedaliera Di Rilievo Nazionale Santobono Pausilipon
  Naples, Italy Recruiting
• CHU Dijon Bourgogne
  Dijon, France Not yet recruiting
• APHP - Hopital Bicetre - Paris Sud
  Le Kremlin-Bicêtre, France Not yet recruiting
• APHM - CHU Timone
  Marseille, France Not yet recruiting

Study contacts

• Study coordinator: Ipsen Clinical Study Enquiries
• Email: clinical.trials@ipsen.com
• Phone: See e mail

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Long-term safety and outcomes of Livmarli for Alagille syndrome in the EU

  This study will follow people with Alagille syndrome who take Livmarli to see if it is safe, well tolerated over the long term, and continues to reduce cholestatic itching.

  Recruiting at 13 sites Phase 4 Mirum Pharmaceuticals, Inc. · Brussels and 14 other locations · NCT07290257

• Observing the long-term effects of odevixibat in patients with Alagille syndrome

  This study looks at how well the medication odevixibat works and its safety for people with Alagille syndrome over a long period of time by collecting their real-life experiences.

  Recruiting at 9 sites Ipsen · Los Angeles, California and 9 other locations · NCT06850038

• Evaluating the long-term safety and outcomes of Livmarli in patients with liver diseases

  This study is testing how safe and effective the medication Livmarli is for people with Alagille syndrome or Progressive familial intrahepatic cholestasis over a five-year period.

  Recruiting at 8 sites Mirum Pharmaceuticals, Inc. · Los Angeles, California and 7 other locations · NCT06193928

• Registry for patients with rare diseases

  This study is creating a central registry for people with rare diseases to help connect them with researchers and improve treatments.

  Recruiting Sanford Health · Sioux Falls, South Dakota · NCT01793168

• Canadian pediatric registry for Alagille syndrome and genetic intrahepatic cholestasis

  This registry collects long-term health and genetic information from children in Canada who have Alagille syndrome or genetic intrahepatic cholestasis to better track outcomes and support research.

  Recruiting at 2 sites Children's Hospital of Eastern Ontario · Calgary, Alberta and 12 other locations · NCT07411716

• Maralixibat (Livmarli) use in Alagille syndrome and PFIC — Japanese database analysis

  This project will look at Japanese patients with Alagille syndrome or PFIC who received maralixibat (Livmarli) to see if taking the drug is linked to liver problems.

  Recruiting Takeda · Tokyo, Tokyo · NCT07293897

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.