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A Post-Authorisation Safety Study Patient Registry of Patients With Neuroblastoma Being Treated With Dinutuximab Beta
Sponsor: RECORDATI GROUP
Summary
This is a non-interventional, multi-national, observational, prospective patient registry to further evaluate the effectiveness and safety of dinutuximab beta - a monoclonal immunoglobulin G 1 (IgG1) antibody, to obtain information on survival, pain severity and incidence of neuro-toxicity, visual impairment, capillary leak syndrome, cardiovascular events, hypersensitivity reactions and long-term safety.
Official title: A Post-Authorisation Safety Study Patient Registry of Patients With High-risk Neuroblastoma Being Treated With the Monoclonal Antibody Dinutuximab Beta
Key Details
Gender
All
Age Range
1 Year - 18 Years
Study Type
OBSERVATIONAL
Enrollment
125
Start Date
2019-09-30
Completion Date
2032-06-15
Last Updated
2024-02-07
Healthy Volunteers
No
Conditions
Interventions
Data-collection
Data will be collected on dose, total cumulative amount of dinutuximab beta per course, dose interruptions, dose discontinuations, prophylactic treatment, use of all concomitant analgesia, assessments of pain, and occurrence of neurotoxicity, visual impairment, capillary leak syndrome, cardiovascular events and hypersensitivity reactions and other AEs.
Locations (13)
St. Anna Kinderkrebsforschung
Vienna, Vienna, Austria
Centre Oscar Lambret
Lille, France
Hôpital de la Timone, Hôpital des Enfants
Marseille, France
Institut Curie
Paris, France
Institut Gustave Roussy
Villejuif, France
Charité Berlin
Berlin, Germany
Universitätsmedizin Greifswald
Greifswald, Germany
IRCCS Istituto Giannina Gaslini
Genova, Italy
Uniwersytecki Szpital Dziecięcy
Krakow, Poland
Hospital Universitario y Politecnico La Fe Avenida Fernando Abril Martorell
Valencia, Spain
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, Newcastle, United Kingdom
Birmingham Children's Hospital
Birmingham, United Kingdom
University Hospital Southampton
Southampton, United Kingdom