Last Update: Jul 27, 2023
An Open-label, Multi-center, Phase IV, Rollover Study for Patients With Sickle Cell Disease Who Have Completed a Prior Novartis-Sponsored Crizanlizumab Study
ClinicalTrials.gov Identifier:
Novartis Reference Number:CSEG101A2401B
All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

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.

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

Sickle Cell Disease
Phase 4
Recruiting
130
Jun 10, 2021
Oct 27, 2031
All
6 Years - (Child, Adult, Older Adult)

Interventions

Drug

Crizanlizumab

Concentrate for solution for infusion for Intravenous use

Eligibility Criteria

Inclusion Criteria:

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 Criteria:

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

Study Location

Novartis Investigative Site

Recruiting

Brussel,1000,Belgium

Novartis Investigative Site

Recruiting

Laeken,1020,Belgium

Novartis Investigative Site

Recruiting

Liege,4000,Belgium

Novartis Investigative Site

Recruiting

Ribeirao Preto,SP,14051-140,Brazil

Novartis Investigative Site

Recruiting

Salvador,BA,41253-190,Brazil

Novartis Investigative Site

Recruiting

São Paulo,SP,01232-010,Brazil

Novartis Investigative Site

Recruiting

Cali,Valle Del Cauca,760012,Colombia

Novartis Investigative Site

Recruiting

Paris cedex 15,75015,France

Novartis Investigative Site

Recruiting

Creteil,94010,France

Novartis Investigative Site

Recruiting

Heidelberg,69120,Germany

Novartis Investigative Site

Recruiting

Padova,PD,35128,Italy

Novartis Investigative Site

Recruiting

Tripoli,1434,Lebanon

Novartis Investigative Site

Recruiting

Beirut,1107 2020,Lebanon

Novartis Investigative Site

Recruiting

Muscat,123,Oman

Novartis Investigative Site

Recruiting

Madrid,28009,Spain

Novartis Investigative Site

Recruiting

Adana,01250,Turkey

Novartis Investigative Site

Recruiting

Adana,01330,Turkey

Novartis Investigative Site

Recruiting

Antakya / Hatay,31100,Turkey

Novartis Investigative Site

Recruiting

Greenville,North Carolina,27834,United States

Novartis Investigative Site

Recruiting

Greenville,North Carolina,27858,United States

Novartis Investigative Site

Recruiting

Washington,District of Columbia,20010,United States

Novartis Investigative Site

Recruiting

Birmingham,Christy Patrick (205-638-2792) email: [email protected] -- Thomas Howard,35233 - Alabama,United States

Novartis Investigative Site

Recruiting

Philadelphia,(267-426-9338) -- Helge D Hartung,19104-4399 - Pennsylvania,United States

Novartis Investigative Site

Recruiting

Fort Worth,Patty Penn email: [email protected] -- Clarissa Johnson,76104 - Texas,United States

Novartis Investigative Site

Recruiting

Augusta,Georgia,30912,United States

Worldwide Contacts

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Novartis Pharmaceuticals

Novartis Pharmaceuticals