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.
|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|
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
Find a Trial Site Location
To find a list of all our recruiting site locations, enter your address below.
Still Have a Question?
Are you a Patient or Caregiver looking for more information?
Are you a Health Care Professional looking for more information?
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