An Open-label, Multi-center, Phase IV, Rollover Study for Patients With Sickle Cell Disease Who Have Completed a Prior Novartis-Sponsored Crizanlizumab Study
Novartis Pharmaceuticals
Summary
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.
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 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 conti…
Eligibility
- Age range
- 0–100 years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugCrizanlizumab
Concentrate for solution for infusion for Intravenous use
Locations (30)
- University Of AlabamaBirmingham, Alabama
- Childrens National HospitalWashington D.C., District of Columbia
- Augusta University GeorgiaAugusta, Georgia
- East Carolina UniversityGreenville, North Carolina
- East Carolina UniversityGreenville, North Carolina
- Childrens Hospital of PhiladelphiaPhiladelphia, Pennsylvania