Study of Dose Confirmation and Safety of Crizanlizumab in Pediatric Sickle Cell Disease Patients
Public ClinicalTrials.gov record NCT03474965. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 2,Multicenter,Open-Label Study to Assess Appropriate Dosing and to Evaluate Safety of Crizanlizumab,With or Without Hydroxyurea/Hydroxycarbamide,in Sequential,Descending Age Groups of Pediatric Sickle Cell Disease Patients With Vaso-Occlusive Crisis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03474965
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 117 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 2 Years to 17 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 1, 2018 (Actual)
- Primary completion
- Nov 6, 2024 (Actual)
- Completion
- Nov 6, 2024 (Actual)
- Last update posted
- Oct 16, 2025
2018 – 2024
United States locations
- U.S. sites
- 12
- U.S. states
- 10
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University Of Alabama | Birmingham | Alabama | 35233 | — |
| Childrens National Hospital | Washington D.C. | District of Columbia | 20010 | — |
| University of Florida | Gainesville | Florida | 32610 | — |
| Joe DiMaggio Childrens Hospital | Hollywood | Florida | 33021 | — |
| Childrens Healthcare of Atlanta | Atlanta | Georgia | 30342 | — |
| Childrens Hosp Boston Dept of Hematology | Boston | Massachusetts | 02115 | — |
| Childrens Hospital at Montefiore | The Bronx | New York | 10467 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| East Carolina University | Greenville | North Carolina | 27834 | — |
| Childrens Hospital Of Philadelphia | Philadelphia | Pennsylvania | 19104-4399 | — |
| Medical Uni of South Carolina | Charleston | South Carolina | 29425 | — |
| Cook Childrens Medical Center | Fort Worth | Texas | 76104 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 23 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03474965, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 16, 2025 · Synced Oct 24, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03474965 live on ClinicalTrials.gov.