Prospective Non-Interventional Study Evaluating the Long-term Safety of Odevixibat in Patients With Alagille Syndrome (ALGS)

Study summary

No information provided.

Study identification

• EU PAS number:
  EUPAS1000000961
• Study ID:
  1000000961
• Official title and acronym:
  Prospective Non-Interventional Study Evaluating the Long-term Safety of Odevixibat in Patients With Alagille Syndrome (ALGS)
• DARWIN EU® study:
  No
• Study countries:
  European Union
• Study description:
  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.
• Study status:
  Planned

Study timelines

Date when funding contract was signed

Planned:21/03/2025

Actual:21/03/2025

Study start date

Planned:30/09/2026

Date of final study report

Planned:31/10/2031

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Ipsen Pharma

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 2 (specific obligation of marketing authorisation)
• Regulatory procedure number:
  EMEA/H/C/006462

Other study registration identification numbers and links

CLIN-60240-034