An Open-label, Multi-center, Phase IV, Rollover Study for Patients With Sickle Cell Disease Who Have Completed a Prior Novartis-Sponsored Crizanlizumab Study
Who is this study for? Patients with sickle cell disease
What treatments are being studied? Crizanlizumab
Status: Recruiting
Location: See all (30) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 6 months
Maximum Age: 100
Healthy Volunteers: f
View:
• 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
• 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 in the parent study
• Patient has demonstrated compliance to the planned visit schedule in the parent study, and in the opinion of the investigator has shown willingness and ability to comply with future visit schedules
Locations
United States
Alabama
University Of Alabama
RECRUITING
Birmingham
Washington, D.c.
Childrens National Hospital
ACTIVE_NOT_RECRUITING
Washington D.c.
Georgia
Augusta University Georgia
RECRUITING
Augusta
North Carolina
East Carolina University
COMPLETED
Greenville
East Carolina University
COMPLETED
Greenville
Pennsylvania
Childrens Hospital of Philadelphia
ACTIVE_NOT_RECRUITING
Philadelphia
Texas
Cook Childrens Medical Center
COMPLETED
Fort Worth
Other Locations
Belgium
Novartis Investigative Site
COMPLETED
Brussels
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Laken
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Liège
Brazil
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Ribeirão Preto
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Salvador
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
São Paulo
Colombia
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Cali
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Montería
Novartis Investigative Site
RECRUITING
Valledupar
France
Novartis Investigative Site
COMPLETED
Créteil
Novartis Investigative Site
COMPLETED
Paris
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Paris
Germany
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Heidelberg
Italy
Novartis Investigative Site
COMPLETED
Orbassano
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Padova
Lebanon
Novartis Investigative Site
RECRUITING
Beirut
Novartis Investigative Site
RECRUITING
Tripoli
Oman
Novartis Investigative Site
RECRUITING
Khoudh
Spain
Novartis Investigative Site
COMPLETED
Barcelona
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Madrid
Turkey
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Adana
Novartis Investigative Site
ACTIVE_NOT_RECRUITING
Adana
Novartis Investigative Site
WITHDRAWN
Hatay
Contact Information
Primary
Novartis Pharmaceuticals
novartis.email@novartis.com
1-888-669-6682
Backup
Novartis Pharmaceuticals
+41613241111
Time Frame
Start Date:2021-06-10
Estimated Completion Date:2031-06-10
Participants
Target number of participants:130
Treatments
Experimental: Crizanlizumab
All participants will receive crizanlizumab (SEG101) at the same dose/schedule as in the parent study.