Rollover Study for Patients With Sickle Cell Disease Who Have Completed a Prior Novartis-Sponsored Crizanlizumab Study
About this study
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.
- Condition
- Sickle Cell Disease
- Tested
- Crizanlizumab
- Sponsor
- Novartis Pharmaceuticals
Who can join
- Age
- 0.5 to 100 years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 6
- Minimum age: 0.5 years
- Maximum age: 100 years
- Study condition: Sickle Cell Disease
- 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
Exclusion 6
- Patient had permanently discontinued from crizanlizumab study treatment in the parent study before the parent study completion
- Ongoing/unresolved treatment-related Grade 3 or higher AEs, and/or any ongoing AE requiring dose interruption. Patients meeting all other eligibility criteria may be enrolled once toxicities have resolved unless those toxicities were grade 4
- Concurrent participation in any other investigational clinical trial other than the parent study or plan to participate in any other investigational clinical trial
- Pregnant or nursing women
- Women of childbearing potential who are unwilling to be on highly effective contraceptives during dosing and until 15 weeks after stopping treatment with crizanlizumab
- SCD patients who do not meet parent study protocol criteria to continue with crizanlizumab
Where
31 sites, 7 recruiting
Novartis Investigative Site
Barranquilla, Atlántico, Colombia
Novartis Investigative Site
Valledupar, Cesar Department, Colombia
Novartis Investigative Site
Beirut, Lebanon
Novartis Investigative Site
Tripoli, Lebanon
Novartis Investigative Site
Khoudh, Oman
Augusta University Georgia
Augusta, Georgia, United States
and 25 more sites on ClinicalTrials.gov
Contact
-
Novartis Pharmaceuticals
1-888-669-6682 novartis.email@novartis.com
-
Novartis Pharmaceuticals
+41613241111
Potential match only. Final eligibility is determined by the study team.