This is a multi-center multi-national rollover study to allow continued access to crizanlizumab for patients with sickle cell disease (SCD) who are on crizanlizumab treatment in a Novartis-sponsored study (parent study) and are benefiting from the treatment as judged by the investigator.
There will be no screening period for this study as patients will transfer directly from parent studies. After providing informed consent, all eligible participants should start Crizanlizumab treatment at the earliest convenience following the treatment schedule of 28 days of the last dose in the parent study. Crizanlizumab will be administered at the same dose/schedule as in the parent study. Study participants will have a safety follow up visit conducted 105 days after last administration of study treatment. The safety follow up at 105 days is not applicable for those participants who continue to receive Crizanlizumab after end of treatment visit either commercially or through PSDS. The study is expected to remain open for 10 years from the first Patient's first visit (FPFV) in this clinical study or until study treatment becomes commercially available and is reimbursed in the respective indication or until such time that all enrolled patients no longer need treatment with Crizanlizumab, or a PSDS treatment plan is allowed and approved as per local laws and regulations, whichever comes first
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
130
Concentrate for solution for infusion for Intravenous use
Not Applicable as this protocol is to provide an option for continued access to crizanlizumab for patients with Sickle Cell Disease who have completed a prior Novartis-sponsored Crizanlizumab study
Protocol to provide an option for continued access to crizanlizumab for patients with Sickle Cell Disease who have completed a prior Novartis-sponsored Crizanlizumab study, benefited from the treatment and do not have access to reimbursed, commercially available crizanlizumab.
Time frame: Not Applicable - Study Completion
Number of participants with treatment emergent adverse events
The number of participants with Frequency, severity and causality of treatment emergent adverse events will be collected.
Time frame: from day of first dose of study medication to 105 days after last dose of study medication
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University Of Alabama
Birmingham, Alabama, United States
RECRUITINGChildrens National Hospital
Washington D.C., District of Columbia, United States
ACTIVE_NOT_RECRUITINGAugusta University Georgia
Augusta, Georgia, United States
RECRUITINGEast Carolina University
Greenville, North Carolina, United States
COMPLETEDEast Carolina University
Greenville, North Carolina, United States
COMPLETEDChildrens Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
ACTIVE_NOT_RECRUITINGCook Childrens Medical Center
Fort Worth, Texas, United States
COMPLETEDNovartis Investigative Site
Brussels, Belgium
COMPLETEDNovartis Investigative Site
Laken, Belgium
ACTIVE_NOT_RECRUITINGNovartis Investigative Site
Liège, Belgium
ACTIVE_NOT_RECRUITING...and 21 more locations