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Open-Label Extension of EryDex Study IEDAT-04-2022
Sponsor: Quince Therapeutics S.p.A.
Summary
This is an international, multi-center, prospective, open-label, non-comparative study aiming to provide access to treatment with EryDex to ataxia telangiectasia (A-T) patients who completed the IEDAT-04-2022 trial which studied the neurological effects of EryDex on subjects with ataxia telangiectasia (NEAT trial).
Official title: An Open-Label Extension Study of EryDex in Patients With Ataxia Telangiectasia Following Participation in Study IEDAT-04-2022 (NEAT)
Key Details
Gender
All
Age Range
6 Years - Any
Study Type
INTERVENTIONAL
Enrollment
101
Start Date
2024-12-11
Completion Date
2026-01-30
Last Updated
2026-05-05
Healthy Volunteers
No
Conditions
Interventions
Dexamethasone sodium phosphate
Dexamethasone Sodium Phosphate encapsulated in autologous erythrocytes and administered via intravenous (IV) infusion
Locations (21)
University of California Los Angeles (UCLA), Ataxia Center and HD Center of excellence
Los Angeles, California, United States
The Johns Hopkins Hospital, Division of pediatric allergy and immunology
Baltimore, Maryland, United States
Saint Peter's University Hospital, Inc.
New Brunswick, New Jersey, United States
Cincinnati Children's Hospital, Division of neurology
Cincinnati, Ohio, United States
UT Health Houston, Department of pediatrics, division of child & adolescent neurology
Houston, Texas, United States
Copenhagen University Hospital, Rigshospitalet, Department of Pediatric Neurology
Copenhagen, Denmark, Denmark
University Hospital Frankfurt, Pediatric and Adolescent Clinic
Frankfurt, Germany, Germany
IKF Pneumologie GmbH & Co. KG; Institut für klinische Forschung Pneumologie Clinical Research Center Respiratory Diseases
Frankfurt am Main, Hesse, Germany
Spedali Civili di Brescia, Pediatric immunology department
Brescia, Italy, Italy
Policlinico Umberto I, La sapienza University, Department of neurosciences and menthal health
Roma, Italy, Italy
Oslo University Hospital, Rikshospitalet, Division of Pediatric and Adolescent Medicine, Norwegian National Unit for Newborn Screening
Oslo, Norway, Norway
MedPolonia sp zoo
Poznan, Poland
Instytut "Pomnik-Centrum Zdrowia Dziecka", Immunology clinic
Warsaw, Poland
Hospital Universitari Vall d'Hebron, Department of pediatric neurology
Barcelona, Spain, Spain
Hospital Universitario La Paz, Department of pediatric neurology
Madrid, Spain, Spain
Universitary Hospital Virgen del Rocío
Seville, Spain
University Children's Hospital Zürich - Eleonore Foundation
Zurich, Switzerland
Great Ormond Street Hospital for Children, Zayed Centre for Research
London, United Kingdom, United Kingdom
Nottingham Children's Hospital, Queen's Medical Center, Children's neurology
Nottingham, United Kingdom, United Kingdom
University Hospitals Birmingham NHS Foundation Trust
Birmingham, United Kingdom
St George's University Hospitals NHS Foundation Trust, Centre for Neonatal and Paediatric Infection
London, United Kingdom