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

NCT04253015 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 125

Last updated 2024-02-07

No results posted yet for this study

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.

Conditions

Interventions

OTHER

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.

Sponsors & Collaborators

  • United BioSource, LLC

    collaborator INDUSTRY

  • RECORDATI GROUP

    lead INDUSTRY

Principal Investigators

  • Jose-Luis Garcia · EUSA Pharma (UK) Limited

Eligibility

Min Age
1 Year
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-30
Primary Completion
2032-03-31
Completion
2032-06-15

Countries

  • Austria
  • France
  • Germany
  • Italy
  • Poland
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04253015 on ClinicalTrials.gov