Sickle Cell Disease (SOLACE-kids)

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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.

All drugs are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

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

If you're interested in this clinical study, your doctor can help evaluate whether you are eligible to participate. Ask your doctor if your medical history or other treatments you're receiving may conflict with the study protocol. If you meet the eligibility criteria and agree to participate in the study: You will be required to sign an informed consent form (ICF). The ICF contains information about the study, which your doctor can help explain to you before you sign. Your doctor will need to complete the necessary tests to see if you are eligible. As with all clinical trials, you have the right to leave the study at any time, for any reason.

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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

4/19 M-GON-1210822