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NCT02693171 · ClinicalTrials.gov registry record
Post-Marketing Assessment of Immunogenicity and Safety of Unituxin® in High-Risk Neuroblastoma Patients
A clinical trial, sponsored by United Therapeutics.
- Terminated
- Registry status
- 13
- Enrollment target
NCT02693171: Clinical Trial study, sponsored by United Therapeutics.
NCT02693171 is a clinical trial that was terminated before completion, run by United Therapeutics. The registered enrollment target is 13 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02693171 was terminated before completion, sponsored by United Therapeutics.
- TERMINATED
- Registry status
- 13 participants
- Enrollment target
Study Summary
The purpose of this study was to assess the incidence of human anti-chimeric antibody (HACA) in high-risk neuroblastoma patients treated with Unituxin combination therapy.
Primary Outcome
Seven blood samples were collected at the following time points for the evaluation of HACA levels: * Course 1- Prior to the first Unituxin infusion * Course 2- Prior to the first Unituxin infusion * Course 3- Prior to the first Unituxin infusion * Course 4- Prior to the first Unituxin infusion * Course 5- Prior to the first Unituxin infusion * Course 6- Prior to the first dose of 13-cis-retinoic acid (RA) * Study termination (approximately 2 weeks following the final 13-cis-retinoic acid dose)
Interventions
- DRUG Dinutuximab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2016-03-15 |
| Est. Completion | 2016-12-19 |
Why NCT02693171 stopped before completion
NCT02693171 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 13 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Dinutuximab is the first listed.
NCT02693171 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02693171 about?
NCT02693171 is a clinical study titled "Post-Marketing Assessment of Immunogenicity and Safety of Unituxin® in High-Risk Neuroblastoma Patients". The purpose of this study was to assess the incidence of human anti-chimeric antibody (HACA) in high-risk neuroblastoma patients treated with Unituxin combination therapy.
What is the current status of trial NCT02693171?
This trial is currently terminated. The enrollment target is 13 participants. The study started on 2016-03-15. Estimated completion is 2016-12-19.
What interventions are being tested in trial NCT02693171?
The interventions under investigation include: Dinutuximab (DRUG).
Who is sponsoring clinical trial NCT02693171?
This trial is sponsored by United Therapeutics, which has 63 total clinical trials registered on ClinicalTrials.gov.
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