Clinical Trial
Study Details
Concentrate for solution for infusion for Intravenous use
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.
Study Overview
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
Contacts and 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
1000 Brussels
Belgium
Novartis Investigative Site
1020 Laken
Belgium
Novartis Investigative Site
4000 Liège
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
94010 Créteil
France
Novartis Investigative Site
75015 Paris
France
Novartis Investigative Site
75015 Paris
France
Novartis Investigative Site
69120 Heidelberg
Germany
Novartis Investigative Site
35128 Padova PD
Italy
Novartis Investigative Site
10043 Orbassano TO
Italy
Novartis Investigative Site
Beirut 113-0236
Lebanon
Novartis Investigative Site
Tripoli 1434
Lebanon
Novartis Investigative Site
123
Khoudh
Oman
Novartis Investigative Site
08035 Barcelona
Spain
Novartis Investigative Site
28009 Madrid
Spain