An Open-Label Extension Study of EryDex in Patients With Ataxia Telangiectasia Following Participation in Study IEDAT-04-2022 (NEAT)
Status: Terminated
Location: See all (21) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
This is an international, multi-center, prospective, open-label, non-comparative study to provide EryDex treatment to ataxia telangiectasia (A-T) patients who complete the IEDAT-04-2022 trial on the neurological effects of EryDex on subjects with ataxia telangiectasia (NEAT trial).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 6
Healthy Volunteers: f
View:
• body weight ≥15 kg
• participation in IEDAT-04-2022 study and its completion, including final efficacy and safety assessments
Locations
United States
California
University of California Los Angeles (UCLA), Ataxia Center and HD Center of excellence
Los Angeles
Maryland
The Johns Hopkins Hospital, Division of pediatric allergy and immunology
Baltimore
New Jersey
Saint Peter's University Hospital, Inc.
New Brunswick
Ohio
Cincinnati Children's Hospital, Division of neurology
Cincinnati
Texas
UT Health Houston, Department of pediatrics, division of child & adolescent neurology
Houston
Other Locations
Denmark
Copenhagen University Hospital, Rigshospitalet, Department of Pediatric Neurology
Copenhagen
Germany
University Hospital Frankfurt, Pediatric and Adolescent Clinic
Frankfurt
IKF Pneumologie GmbH & Co. KG; Institut für klinische Forschung Pneumologie Clinical Research Center Respiratory Diseases
Frankfurt Am Main
Italy
Spedali Civili di Brescia, Pediatric immunology department
Brescia
Policlinico Umberto I, La sapienza University, Department of neurosciences and menthal health
Roma
Norway
Oslo University Hospital, Rikshospitalet, Division of Pediatric and Adolescent Medicine, Norwegian National Unit for Newborn Screening
Oslo
Poland
MedPolonia sp zoo
Poznan
Instytut Pomnik-Centrum Zdrowia Dziecka, Immunology clinic
Warsaw
Spain
Hospital Universitari Vall d'Hebron, Department of pediatric neurology
Barcelona
Hospital Universitario La Paz, Department of pediatric neurology
Madrid
Universitary Hospital Virgen del Rocío
Seville
Switzerland
University Children's Hospital Zürich - Eleonore Foundation
Zurich
United Kingdom
University Hospitals Birmingham NHS Foundation Trust
Birmingham
Great Ormond Street Hospital for Children, Zayed Centre for Research
London
St George's University Hospitals NHS Foundation Trust, Centre for Neonatal and Paediatric Infection
London
Nottingham Children's Hospital, Queen's Medical Center, Children's neurology
Nottingham
Time Frame
Start Date: 2024-12-11
Completion Date: 2026-01-30
Participants
Target number of participants: 101
Treatments
Experimental: Dexamethasone sodium phosphate
intravenous (IV) infusion of dexamethasone sodium phosphate (DSP) encapsulated in autologous erythrocytes using the EryDex System (EDS)
Related Therapeutic Areas
Sponsors
Collaborators: Biotrial
Leads: Quince Therapeutics S.p.A.