Rollover Study for Patients With Sickle Cell Disease Who Have Completed a Prior Novartis-Sponsored Crizanlizumab Study
- Registration Number
- NCT04657822
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief 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.
- Detailed Description
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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 130
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Crizanlizumab Crizanlizumab All participants will receive crizanlizumab (SEG101) at the same dose/schedule as in the parent study.
- Primary Outcome Measures
Name Time Method Not Applicable as this protocol is to provide an option for continued access to crizanlizumab for patients with Sickle Cell Disease who have completed a prior Novartis-sponsored Crizanlizumab study Not Applicable - Study Completion Protocol to provide an option for continued access to crizanlizumab for patients with Sickle Cell Disease who have completed a prior Novartis-sponsored Crizanlizumab study, benefited from the treatment and do not have access to reimbursed, commercially available crizanlizumab.
- Secondary Outcome Measures
Name Time Method Number of participants with treatment emergent adverse events from day of first dose of study medication to 105 days after last dose of study medication The number of participants with Frequency, severity and causality of treatment emergent adverse events will be collected.
Trial Locations
- Locations (7)
University Of Alabama
🇺🇸Birmingham, Alabama, United States
Childrens National Hospital
🇺🇸Washington, District of Columbia, United States
Augusta University Georgia
🇺🇸Augusta, Georgia, United States
East Carolina University
🇺🇸Greenville, North Carolina, United States
Childrens Hospital Of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Cook Childrens Medical Center
🇺🇸Fort Worth, Texas, United States
Novartis Investigative Site
🇹🇷Antakya Hatay, Turkey