An Investigation of the Safety and Efficacy of Odevixibat in Patients
Research type
Research Study
Full title
A Phase 3 Double-blind, Randomized, Placebo-controlled Study of the Safety and Efficacy of Odevixibat (A4250) in Patients with Alagille Syndrome (ASSERT)
IRAS ID
290339
Contact name
Alastair Baker
Contact email
Sponsor organisation
Albireo AB
Eudract number
2020-004011-28
ISRCTN Number
ISRCTN00000000
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
0 years, 10 months, 23 days
Research summary
A company called Albireo AB has begun a study of an investigational drug called odevixibat as a possible treatment for itching associated with Alagille Syndrome (ALGS). An investigational drug is one that has not been approved for use by health authorities. ALGS is a rare disease that can cause problems in the liver and other body parts. In the liver, the bile ducts do not develop properly leading to difficulty getting bile out of the liver. This can lead to increased bile acids in the liver and liver damage. This study will take place in approximately 35 sites globally with up to 60 children or adults with ALGS to be enrolled. About 5 children or adults will be enrolled from the United Kingdom sites. This study will last for approximately 36 weeks, and will involve at least 9 visits to the study site over this period
REC name
London - City & East Research Ethics Committee
REC reference
21/LO/0132
Date of REC Opinion
9 Apr 2021
REC opinion
Further Information Favourable Opinion