Actively Recruiting
Observing Long-Term Safety of Odevixibat in Patients with Alagille Syndrome ALGS Receiving Treatment
Led by Ipsen · Updated on 2026-08-03
30
Participants Needed
14
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are observing patients with Alagille Syndrome ALGS, a rare liver condition that causes itching, who are using the medication odevixibat in their daily lives. The main goal is to monitor the long-term safety of odevixibat in patients receiving ongoing treatment for ALGS. This is a non-interventional observational study focused on collecting real-world safety information. Participants in this study continue their regular odevixibat treatment as prescribed by their healthcare providers. The study does not involve changing or administering treatments but follows patients over approximately five years to gather safety data. Researchers will track various health aspects, including adverse events, liver function tests, vitamin levels, and hospitalizations related to diarrhea, hepatotoxicity, and vitamin deficiencies. Throughout the study, participants will have their health monitored at regular intervals to assess safety outcomes. Data collected include reports of adverse events, changes in liver enzymes, vitamin deficiencies, and any hospitalizations or treatment discontinuations related to side effects. The study aims to provide a comprehensive picture of how odevixibat affects patients over the long term while they receive usual care for ALGS.
CONDITIONS
Brief Title
A Study to Observe the Long-term Safety of Odevixibat in Patients With Alagille Syndrome (ALGS) Who Are Receiving Ongoing Treatment
Research Team
I
Ipsen Clinical Study Enquiries
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