An Open-label, Multi-center, Phase IV, Rollover Study for Patients With Sickle Cell Disease Who Have Completed a Prior Novartis-Sponsored Crizanlizumab Study

About the 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.

Study point of contact

Novartis Pharmaceuticals
+41613241111
Novartis Pharmaceuticals
1-888-669-6682
[email protected]

Locations

3 United States sites

3 Brazil sites

3 Turkey sites

2 Belgium sites

2 Italy sites

2 Lebanon sites

1 Colombia site

1 France site

1 Oman site

1 Germany site

1 Spain site

Age

> 6 Years

Phase

Phase 4

Study type

Interventional

Age

6 Months -

Gender

All

Interventions

Drug

Compensation

Unknown

participation requirements

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

participation restrictions

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

Locations

  • Birmingham, Alabama, United States, University of Alabama 1600 7th ave, 35233 [Recruiting]
  • Philadelphia, Pennsylvania, United States, Children s Hospital of Philadelphia Patient Treatment, 19104-4399 [Recruiting]
  • Fort Worth, Texas, United States, Cook Childrens Medical Center, 76104 [Recruiting]
  • Brussel, Belgium, Novartis Investigative Site, 1000 [Recruiting]
  • Liege, Belgium, Novartis Investigative Site, 4000 [Recruiting]
  • Salvador, BA, Brazil, Novartis Investigative Site, 41253-190 [Recruiting]
  • Ribeirao Preto, SP, Brazil, Novartis Investigative Site, 14051-140 [Recruiting]
  • São Paulo, SP, Brazil, Novartis Investigative Site, 01232-010 [Recruiting]
  • Cali, Valle Del Cauca, Colombia, Novartis Investigative Site [Recruiting]
  • Paris, France, Novartis Investigative Site, 75015 [Recruiting]
  • Heidelberg, Germany, Novartis Investigative Site, 69120 [Recruiting]
  • Orbassano, Italy, Novartis Investigative Site, 10043 [Recruiting]
  • Padova, Italy, Novartis Investigative Site, 35128 [Recruiting]
  • Beirut, Lebanon, Novartis Investigative Site, 1107 2020 [Recruiting]
  • Tripoli, Lebanon, Novartis Investigative Site, 1434 [Recruiting]
  • Muscat, Oman, Novartis Investigative Site, 123 [Recruiting]
  • Madrid, Spain, Novartis Investigative Site, 28009 [Recruiting]
  • Adana, Turkey, Novartis Investigative Site, 01250 [Recruiting]
  • Adana, Turkey, Novartis Investigative Site, 01330 [Recruiting]
  • Antakya / Hatay, Turkey, Novartis Investigative Site, 31100 [Recruiting]
Last updated 2022-03-29