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

StatusActive, Not Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 4 years 3 months later Mar 31, 2032 → Jun 30, 2036
See other at-risk trials from RECORDATI GROUP

Record History

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  1. Primary completion pushed from Mar 31, 2032 to Jun 30, 2036 Show 5 more changesShow less
    • Enrollment closed, study ongoing
    • Study completion pushed from Jun 15, 2032 to Jun 30, 2036
    • Study description expanded, about 6 words
    • Study sites revised (13)
    • Eligibility criteria expanded, about 5 words
  2. Re-verified, no change to tracked fieldsv8
  3. Study sites: 14 to 13v7
  4. Re-verified, no change to tracked fieldsv6
  5. Site details revised at 5 of 14 sitesv5
Show 3 earlier versionsHide 3 earlier versions
  1. Site details revised at 4 of 14 sitesv4
  2. Site details revised at 9 of 14 sitesv3
  3. Trial status: Active, Not Recruiting to Recruiting
    • Study sites: 13 to 14
    • Primary completion date: Oct 30, 2031 to Mar 31, 2032
    • Study completion date: Jan 15, 2032 to Jun 15, 2032
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04253015
Lead Sponsor RECORDATI GROUP
Collaborators: United BioSource, LLC
Conditions
(from sponsor)		 Neuroblastoma
Related terms Brain Neoplasms, Neoplasms, Neuroblastoma
Enrollment 125 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov