Rollover Study for Patients With Sickle Cell Disease Who Have Completed a Prior Novartis-Sponsored Crizanlizumab Study
Rollover Study for Patients With Sickle Cell Disease Who Have Completed a Prior Novartis-Sponsored Crizanlizumab Study
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.

 After 105 days of the last dose of the parent study the participants will have a safety
 follow up visit (overlapping with the treatment phase of the study).

 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, whichever comes first.
Inclusion Criteria:

 1. Written informed consent/assent, according to local guidelines, signed by the adult
 patients. In the population under 18 years, it will be signed by the patient and/or by
 the parents or legal guardian prior to enrolling in the rollover study and receiving
 study medication

 2. SCD patient currently enrolled in a Novartis-sponsored study receiving crizanlizumab
 and has fulfilled all the requirements in the parent study. Patient is currently
 benefiting from the treatment with crizanlizumab as determined by the investigator and
 has completed the treatment schedule as planned in the parent study

 3. Patient has demonstrated compliance to the planned visit schedule in the parent study,
 and in the opinion of the investigator has shown willingness and ability to comply
 with future visit schedules

 Exclusion Criteria:

 1. Patient had permanently discontinued from crizanlizumab study treatment in the parent
 study before the parent study completion

 2. Ongoing/unresolved treatment-related Grade 3 or higher AEs, and/or any ongoing AE
 requiring dose interruption. Patients meeting all other eligibility criteria may be
 enrolled once toxicities have resolved unless those toxicities were grade 4

 3. Concurrent participation in any other investigational clinical trial other than the
 parent study or plan to participate in any other investigational clinical trial

 4. Pregnant or nursing women

 5. Women of childbearing potential who are unwilling to be on highly effective
 contraceptives during dosing and until 15 weeks after stopping treatment with
 crizanlizumab

 6. SCD patients who do not meet parent study protocol criteria to continue with
 crizanlizumab