Trials / Terminated
TerminatedNCT02693171
Post-Marketing Assessment of Immunogenicity and Safety of Unituxin® in High-Risk Neuroblastoma Patients
A Post-Marketing Study to Further Assess the Immunogenicity and Safety of Unituxin® in High-Risk Neuroblastoma Patients
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 13 (actual)
- Sponsor
- United Therapeutics · Industry
- Sex
- All
- Age
- 1 Year – 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
This was a multi-center, non-randomized, open-label study in patients with high-risk neuroblastoma to assess the immunogenicity, safety and tolerability of Unituxin combination therapy. Patients enrolled in the study were prescribed Unituxin for the treatment of high-risk neuroblastoma.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Dinutuximab | Unituxin was administered along with cytokines according to the prescribing information |
Timeline
- Start date
- 2016-03-15
- Primary completion
- 2016-12-19
- Completion
- 2016-12-19
- First posted
- 2016-02-26
- Last updated
- 2019-08-05
- Results posted
- 2019-08-05
Locations
18 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02693171. Inclusion in this directory is not an endorsement.