Rollover Study for Patients With Sickle Cell Disease Who Have Completed a Prior Novartis-Sponsored Crizanlizumab Study
Start Date
6/10/2021
Completion Date
6/10/2031
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.
Detailed 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 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
Eligibility Criteria
Age Range: No minimum to 100 years
Interventions
Crizanlizumab
Conditions
Locations
University Of Alabama
Birmingham, Alabama 35233
United States
Childrens National Hospital
Washington D.C., District of Columbia 20010
United States
Augusta University Georgia
Augusta, Georgia 30912
United States
East Carolina University
Greenville, North Carolina 27834
United States
East Carolina University
Greenville, North Carolina 27858
United States
Childrens Hospital of Philadelphia
Philadelphia, Pennsylvania 19104-4399
United States
Cook Childrens Medical Center
Fort Worth, Texas 76104
United States
Novartis Investigative Site
Brussels, 1000
Belgium
Novartis Investigative Site
Laken, 1020
Belgium
Novartis Investigative Site
Liège, 4000
Belgium
Novartis Investigative Site
Salvador, Estado de Bahia 41253-190
Brazil
Novartis Investigative Site
Ribeirão Preto, São Paulo 14051-140
Brazil
Novartis Investigative Site
São Paulo, São Paulo 01232-010
Brazil
Novartis Investigative Site
Barranquilla, Atlántico 080020
Colombia
Novartis Investigative Site
Valledupar, Cesar Department 200001
Colombia
Novartis Investigative Site
Cali, Valle del Cauca Department 760032
Colombia
Novartis Investigative Site
Montería, 230004
Colombia
Novartis Investigative Site
Créteil, 94010
France
Novartis Investigative Site
Paris, 75015
France
Novartis Investigative Site
Paris, 75015
France
Novartis Investigative Site
Heidelberg, 69120
Germany
Novartis Investigative Site
Padova, PD 35128
Italy
Novartis Investigative Site
Orbassano, TO 10043
Italy
Novartis Investigative Site
Beirut, 113-0236
Lebanon
Novartis Investigative Site
Tripoli, 1434
Lebanon
Novartis Investigative Site
Khoudh, 123
Oman
Novartis Investigative Site
Barcelona, 08035
Spain
Novartis Investigative Site
Madrid, 28009
Spain
Novartis Investigative Site
Hatay, Antakya 31101
Turkey (Türkiye)
Novartis Investigative Site
Adana, Saricam 01330
Turkey (Türkiye)
Novartis Investigative Site
Adana, Yuregir 01250
Turkey (Türkiye)