Study with New Medicine, called Odevixibat, in Patients with Alagille
Research type
Research Study
Full title
An Open Label Study to Evaluate the Long-term Safety and Efficacy of Odevixibat (A4250) in Patients with Alagille Syndrome (ASSERT-EXT)
IRAS ID
302546
Contact name
Alastair Baker
Contact email
Eudract number
2021-000996-36
Clinicaltrials.gov Identifier
IND Number, 145988
Duration of Study in the UK
3 years, 0 months, 22 days
Research summary
Albireo AB is developing the investigational drug (also known as the “study drug”) odevixibat as a possible treatment for itching associated with Alagille Syndrome (ALGS).
The study drug is believed to lower bile acid levels in the blood and liver by reducing uptake of bile acids from the intestine to the liver. Lowering bile acid levels may lead to decreased itching. Odevixibat has been tested in healthy volunteers and in a study in children (aged 6 months old or older) with liver diseases and elevated bile acids, including ALGS patients.
The main purpose of this study is to learn how safe and effective the study drug is long-term. This study will take place in approximately 35 centres globally with up to approximately 60 children or adults with ALGS. The study is divided into a 72 week treatment period and a 4-week follow-up period.REC name
London - Central Research Ethics Committee
REC reference
21/LO/0592
Date of REC Opinion
30 Nov 2021
REC opinion
Further Information Favourable Opinion