Long-term Phase IV Study Allowing Continued Crizanlizumab Treatment for Sickle Cell Disease Patients After Completing a Previous Novartis Study

What this Trial Is About

This research focuses on patients with sickle cell disease SCD who have previously taken part in a Novartis-sponsored study using crizanlizumab. The study provides continued access to crizanlizumab for those who are benefiting from the treatment as judged by their doctor. It is a multi-center and multi-national phase IV rollover study aimed at offering ongoing treatment options for these patients. Participants will continue receiving crizanlizumab at the same dose and schedule they had in their prior study. There is no screening period since patients transfer directly from the parent studies. After giving consent, treatment should begin as soon as possible, following the last dose schedule from the parent study. The study will remain open for up to 10 years or until the treatment becomes commercially available and reimbursed, or when the patients no longer need crizanlizumab. During the study, participants will have regular visits to monitor safety and treatment effects. A safety follow-up visit is planned 105 days after the last dose for those who stop treatment. However, this follow-up is not required if patients continue treatment commercially or through approved plans. Researchers will track any treatment-related side effects from the first dose until 105 days after the last dose. Overall participation duration varies based on treatment continuation and availability.

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