A Study to Observe the Long-term Safety of Odevixibat in Patients With Alagille Syndrome (ALGS) Who Are Receiving Ongoing Treatment

Recruiting now

Conditions studied: Alagille Syndrome

In brief

This study will collect information from patients with ALGS who are using odevixibat in their daily lives. Odevixibat is a medication that helps patients with ALGS, a rare disease that affects the liver and causes itching. The main aim of this study is to observe the long-term, everyday safety of the drug odevixibat in patients with ALGS who are receiving ongoing treatment.

Key facts

Study ID

NCT07585097

Run by

Ipsen

People needed

30

Starts

2026-07-10

Expected to finish

2031-09-30

Last updated by the study team

2026-08-03

Who can join

Age: 1 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosed with ALGS.
• On (or starting) active odevixibat treatment.
• Aged 6 months or older at the time of consent.

You may not qualify if…

• 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 is running

• Azienda Ospedaliero Universitaria Meyer — Florence, Italy (enrolling)
• Ospedale Universitario Di Udine — Udine, Italy
• Hospices Civils de Lyon - Hopital Femme Mere Enfant — Bron, France
• CHU Dijon Bourgogne — Dijon, France
• APHP - Hopital Bicetre - Paris Sud — Le Kremlin-Bicêtre, France
• APHM - CHU Timone — Marseille, France
• CHU de Montpellier - Hopital Saint Eloi — Montpellier, France
• APHP - Hopital Necker-Enfants Malades — Paris, France
• CHU de Toulouse - Hopital Paule de Viguier — Toulouse, France
• APHP - Centre Hepato-Biliaire Hospital Paul Brousse — Villejuif, France
• Azienda Ospedaliera Di Rilievo Nazionale Santobono Pausilipon — Naples, Italy
• University Hospital Of Padova — Padova, Italy
• A.O.U. Citta della Salute e della Scienza di Torino - Ospedale Infantile Regina Margherita — Torino, Italy
• IRCCS Ospedale Pediatrico Bambino Gesu — Roma, Italy

Full record on ClinicalTrials.gov

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