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New treatment option for Sickle Cell Disease
Official title Rollover Study for Patients With Sickle Cell Disease Who Have Completed a Prior Novartis-Sponsored Crizanlizumab Study
ClinicalTrials.gov ID: NCT04657822
What this study is testing
What is Crizanlizumab?
Crizanlizumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for sickle cell disease.
Also referred to as SEG101.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 100
You may be able to join if
- Written informed consent/assent, according to local guidelines, signed by the adult patients. In the population under 18 years, it will be signed by...
- SCD patient currently enrolled in a Novartis-sponsored study receiving crizanlizumab and has fulfilled all the requirements 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...
You likely can't join if
- 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...
- Concurrent participation in any other investigational clinical trial other than the parent study or plan to participate in any other investigational...
- 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...
- SCD patients who do not meet parent study protocol criteria to continue with crizanlizumab
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Washington D.C., District of Columbia, United States
- Augusta, Georgia, United States
- Greenville, North Carolina, United States
- Philadelphia, Pennsylvania, United States
- Fort Worth, Texas, United States
- Brussels, Belgium
- Laken, Belgium
- Liège, Belgium
- Salvador, Estado de Bahia, Brazil
- Ribeirão Preto, São Paulo, Brazil
- São Paulo, São Paulo, Brazil
- Barranquilla, Atlántico, Colombia
- Valledupar, Cesar Department, Colombia
- Cali, Valle del Cauca Department, Colombia
- Montería, Colombia
- Créteil, France
- Paris, France
- Heidelberg, Germany
- Padova, PD, Italy
+ 9 more site(s).
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 months to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Washington D.C., District of Columbia, United States; Augusta, Georgia, United States; Greenville, North Carolina, United States; Philadelphia, Pennsylvania, United States; Fort Worth, Texas, United States and 23 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.