Sickle Cell Disease (SOLACE-kids)
A Phase II, 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.
Overview
| This study is recruiting: Phase II | Actual Start Date: [October 1, 2018] | Estimated Completion Date: [April 28, 2022] | Novartis Reference Number: CSEG101B2201 |
| Condition: Sickle Cell Disease | Interventions: crizanlizumab | Estimated Enrollment: [100 participants] | ClinicalTrials.gov Identifier: NCT03474965 |
| This study is recruiting: Phase II | Actual Start Date: [October 1, 2018] |
| Estimated Completion Date: [April 28, 2022] | Novartis Reference Number: CSEG101B2201 |
| Condition: Sickle Cell Disease | Interventions: crizanlizumab |
| Estimated Enrollment: [100 participants] | ClinicalTrials.gov Identifier: NCT03474965 |
Study Goal
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.
Eligibility
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.
Definitions:
HU/HC - Hydroxyurea/Hydroxycarbamide, PD - pharmacodynamics, VOC - Vaso-Occlusive Crisis, PK - Pharmacokinetics
Last Updated: May 1, 2019
