Clinical Trial

A Post-Authorisation Safety Study Patient Registry of Patients With Neuroblastoma Being Treated With Dinutuximab Beta

Recruiting
View on ClinicalTrials.gov →
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.
Protocol Amendment History 7 amendments
This ClinicalTrials.gov record has been amended 7 times since 2020-01-31; most recent amendment 2024-02-06.
Status change: Active, Not Recruiting → Recruiting 2020-09-29
Trial Details
NCT Number NCT04253015
Lead Sponsor RECORDATI GROUP
Collaborators: United BioSource, LLC
Conditions Neuroblastoma
Enrollment 125 participants
Start Date 2019-09-30
Primary Completion 2032-03-31 (estimated)
Study Completion 2032-06-15 (estimated)
Updated on ClinicalTrials.gov 2024-02-07