ProjectASSERT – An Open Label Study to Evaluate the Long-term Safety and Efficacy of Odevixibat (A4250) in Patients with…
Basic data
Acronym:
ASSERT
Title:
An Open Label Study to Evaluate the Long-term Safety and Efficacy of Odevixibat (A4250) in Patients with Alagille Syndrome (ASSERT-EXT)
Duration:
12/05/2022 to 01/07/2024
Abstract / short description:
Primary objective: To demonstrate the efficacy of repeated daily
doses of 120 μg/kg/day odevixibat in relieving pruritus in patients
with ALGS. Secondary Objectives: To assess the impact of
odevixibat on serum bile acid levels in patients with ALGS. To
evaluate the safety and tolerability of odevixibat in patients with
ALGS.
doses of 120 μg/kg/day odevixibat in relieving pruritus in patients
with ALGS. Secondary Objectives: To assess the impact of
odevixibat on serum bile acid levels in patients with ALGS. To
evaluate the safety and tolerability of odevixibat in patients with
ALGS.
Involved staff
Managers
Faculty of Medicine
University of Tübingen
University of Tübingen
Other staff
Faculty of Medicine
University of Tübingen
University of Tübingen
Local organizational units
Paediatrics Department I and Polyclinic
University Children’s Hospital - Department of Paediatrics
Hospitals and clinical institutes, Faculty of Medicine
Hospitals and clinical institutes, Faculty of Medicine
Funders
Göteborg, Sweden