Sickle Cell Disease (SOLACE-kids)
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.
|This Study Is Recruiting: Phase II
||Actual Start Date: [October 1, 2018]||Estimated Completion Date: [September 28, 2023]||Novartis Reference Number: CSEG101B2201|
|Condition: Sickle Cell Disease||Interventions: crizanlizumab||Estimated Enrollment: [100 participants]||ClinicalTrials.gov Identifier: NCT03474965|
|This Study Is: Phase II||Actual Start Date: [October 1, 2018]|
|Estimated Completion Date: [September 28, 2023]||Novartis Reference Number: CSEG101B2201|
|Condition: Sickle Cell Disease||Interventions: crizanlizumab|
|Estimated Enrollment: [100 participants]||ClinicalTrials.gov Identifier: NCT03474965|
The purpose of the Phase 2 CSEG101B2201 study is to confirm and to establish appropriate dosing and to evaluate the safety in pediatric patients ages 6 months to <18 years with a history of VOC with or without HU/HC, receiving crizanlizumab for 2 years. The efficacy and safety of crizanlizumab was already demonstrated in adults with sickle cell disease. The approach is to extrapolate from the PK/pharmacodynamics (PD) already established in the adult population. The study is designed as a Phase II, multicenter, open-label study.
Participants may be eligible to participate if they:
- Are 6 months to <18 years of age*
- Have a confirmed diagnosis of sickle cell disease
- Experienced at least 1 vaso-occlusive crisis within the last 12 months prior to screening
- Meet other eligibility criteria
* Enrollment will be expanded for patients aged 6 to <24 months (and at least 6 kg) once the appropriate dose is confirmed in 2 to <6 year old patients
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To view eligibility requirements for this trial, arms and interventions, trial sites and study design, please click to visit this trial on www.clinicaltrials.gov.
HU/HC - Hydroxyurea/Hydroxycarbamide, PD - pharmacodynamics, VOC - Vaso-Occlusive Crisis, PK - Pharmacokinetics
Last Updated: May 1, 2019