Clinical Trials in France / NCT07585097
Recruiting
Observational
A Study to Observe the Long-term Safety of Odevixibat in Patients With Alagille Syndrome (ALGS) Who Are Receiving Ongoing Treatment
NCT07585097 · tracked via the Priya Life Science France tracker
Condition(s) studied
Alagille Syndrome
Study summary
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.
Eligibility
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.
Primary outcome measure(s)
- Percentage of participants experiencing adverse events (AEs) — From first ICF signature and up to end of data collection (approximately 5 years of data collection)
An adverse event (AE) is any untoward medical occurrence in a participant administered odevixibat, whether or not considered related to treatment. - Percentage of participants experiencing serious adverse events (SAEs) — From first ICF signature and up to end of data collection (approximately 5 years of data collection)
An adverse event (AE) is any untoward medical occurrence in a participant administered odevixibat, whether or not considered related to treatment.
Trial sites (14)
| Facility | City | Region | Status |
|---|---|---|---|
| Hospices Civils de Lyon - Hopital Femme Mere Enfant | Bron | France | Not Yet 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 |
| CHU de Montpellier - Hopital Saint Eloi | Montpellier | France | Not Yet Recruiting |
| APHP - Hopital Necker-Enfants Malades | Paris | France | Not Yet Recruiting |
| CHU de Toulouse - Hopital Paule de Viguier | Toulouse | France | Not Yet Recruiting |
| APHP - Centre Hepato-Biliaire Hospital Paul Brousse | Villejuif | France | Not Yet Recruiting |
| Azienda Ospedaliero Universitaria Meyer | Florence | Italy | Recruiting |
| Azienda Ospedaliera Di Rilievo Nazionale Santobono Pausilipon | Naples | Italy | Recruiting |
| University Hospital Of Padova | Padova | Italy | Not Yet Recruiting |
| IRCCS Ospedale Pediatrico Bambino Gesu | Roma | Italy | Not Yet Recruiting |
| A.O.U. Citta della Salute e della Scienza di Torino - Ospedale Infantile Regina Margherita | Torino | Italy | Not Yet Recruiting |
| Ospedale Universitario Di Udine | Udine | Italy | Not Yet Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07585097 on ClinicalTrials.gov ↗ ← All trials in France