Rollover Study for Patients With Sickle Cell Disease Who Have Completed a Prior Novartis-Sponsored Crizanlizumab Study
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Sickle Cell Disease
- Type
- Interventional
- Phase
- Phase 4
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Younger than 125 years
- Gender
- Both males and females
Description
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 pa...
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.
Tracking Information
- NCT #
- NCT04657822
- Collaborators
- Not Provided
- Investigators
- Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals