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NCT03474965 · ClinicalTrials.gov registry record · Phase 2
Study of Dose Confirmation and Safety of Crizanlizumab in Pediatric Sickle Cell Disease Patients
A Phase 2 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 117
- Enrollment target
NCT03474965 is a Phase 2 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 117 participants.
The verdict
NCT03474965, a Phase 2 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 117 participants
- Enrollment target
Study Summary
The purpose of this study was to confirm and to establish appropriate dosing and to evaluate the safety in pediatric participants ages 2 to \<18 years with a history of Vaso-Occlusive Crisis (VOC) with or without Hydroxyurea/Hydroxycarbamide (HU/HC), receiving crizanlizumab for 2 years. The efficacy and safety of crizanlizumab was previously demonstrated in adults with sickle cell disease. The approach was to extrapolate from the pharmacokinetics (PK)/pharmacodynamics (PD) already established in the adult population. The study was designed as a Phase II, multicenter, open-label study.
Interventions
- DRUG Crizanlizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 117 participants |
| Start Date | 2018-10-01 |
| Est. Completion | 2024-11-06 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03474965
The ClinicalTrials.gov registry entry for NCT03474965 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 117 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Crizanlizumab is the first listed.
NCT03474965 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03474965 about?
NCT03474965 is a clinical study titled "Study of Dose Confirmation and Safety of Crizanlizumab in Pediatric Sickle Cell Disease Patients". The purpose of this study was to confirm and to establish appropriate dosing and to evaluate the safety in pediatric participants ages 2 to \<18 years with a history of Vaso-Occlusive Crisis (VOC) with or without Hydroxyurea/Hydroxycarbamide (HU/HC), receiving crizanlizumab for 2 years. The efficacy...
What is the current status of trial NCT03474965?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 117 participants. The study started on 2018-10-01. Estimated completion is 2024-11-06.
What interventions are being tested in trial NCT03474965?
The interventions under investigation include: Crizanlizumab (DRUG).
Who is sponsoring clinical trial NCT03474965?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
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