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Clinical Trials in Italy / NCT05426733
Active, not recruiting Phase 3

An Open-label Extension Study to Evaluate Long-term Efficacy and Safety of Odevixibat in Children With Biliary Atresia

NCT05426733 · tracked via the Priya Life Science Italy tracker
Sponsor
Albireo, an Ipsen Company
Phase
Phase 3
Started
2022-07-05
Last updated
2026-10-01

Condition(s) studied

Biliary Atresia

Investigational drug(s) / intervention(s)

Odevixibat →

Odevixibat: Odevixibat is a small molecule inhibitor of the ileal bile acid transporter (IBAT).

Study summary

An Open-label Extension Study to Evaluate Long-term Efficacy and Safety of Odevixibat (A4250) in Children with Biliary Atresia

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Completion of the 104-week Treatment Period of Study A4250-011 * Signed informed consent by caregiver Exclusion Criteria: * Patients who were not compliant with study drug treatment or procedures in Study A4250-011 as per the investigator's discretion * Any conditions or abnormalities which, in the opinion of the investigator, may compromise the safety of the patient, or interfere with the patient participating in or completing the study * Known hypersensitivity to any components of odevixibat * Patients who are scheduled for a liver transplant or are likely to require a liver transplant in the immediate future based on the investigator's judgment

Primary outcome measure(s)

  • Proportion of patients who are alive and have not undergone liver transplant — From baseline to Week 104

Trial sites (30)

FacilityCityRegionStatus
Children's Hospital Colorado Aurora Colorado
Children's Healhcare of Atlanta- Emory University school of medicine Atlanta Georgia
Indiana University school of Medicine Indianapolis Indiana
Boston Children's Hospital Boston Massachusetts
Children's Mercy Hospital and Clinics Kansas City Missouri
Hassenfeld Children's Hospital at NYU Langone New York New York
Columbia University Medical Center New York Presbyterian Morgan Stanley-Komansky Childrens Hospital New York New York
The Childrens Hospital at Montefiore Albert Einstein School of Medicine The Bronx New York
Cincinnati Children's Hospital Medical Center Cincinnati Ohio
Seattle Children's Hospital Seattle Washington
Royal Children's Hospital Parkville Australia
CHU Sainte-Justine Montreal Canada
The Hospital for Sick Children Toronto Canada
Guangzhou Women And Childrens Medical Center Guangdong China
Children's Hospital of Fudan University Shanghai China
Bicêtre Hospital Le Kremlin-Bicêtre France
Charité - Universitätsmedizin Berlin Berlin Germany
University Children´s Hospital Tuebingen Tübingen Germany
ASST Papa Giovanni XXIII Bergamo Italy
Azienda Ospedaliera di Padova Padova Italy
Hospital Raja Perempuan Zainab II Kota Bharu Malaysia
University Malaya Medical Centre Kuala Lumpur Malaysia
University Medical Center Groningen Groningen Netherlands
Starship Child Health, Te Whatu Ora - Health New Zealand Auckland New Zealand
Instytut Pomnik-Centrum Zdrowia Dziecka Warsaw Poland
Seoul National University Childrens Hospital Seoul South Korea
Hospital Universitari Vall d'Hebron Barcelona Spain
Hacettepe İhsan Doğramacı Children's Hospital Ankara Turkey (Türkiye)
Akdeniz University Medical Faculty Antalya Turkey (Türkiye)
Istanbul University Istanbul Medical Faculty Hospital Istanbul Turkey (Türkiye)

More Albireo, an Ipsen Company trials in Italy

Long-term Safety and Efficacy of Odevixibat in Patients With Alagille Syndrome Active, not recruiting
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 NCT05426733 on ClinicalTrials.gov ↗ ← All trials in Italy