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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-004225-22 | EudraCT Number |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Crizanlizumab | Experimental | All participants will receive crizanlizumab (SEG101) at the same dose/schedule as in the parent study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Crizanlizumab | Drug | Concentrate for solution for infusion for Intravenous use |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | Not Applicable - Study Completion |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment emergent adverse events | The number of participants with Frequency, severity and causality of treatment emergent adverse events will be collected. | from day of first dose of study medication to 105 days after last dose of study medication |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Novartis Pharmaceuticals | Contact | 1-888-669-6682 | novartis.email@novartis.com | |
| Novartis Pharmaceuticals | Contact | +41613241111 |
| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Of Alabama | Recruiting | Birmingham | Alabama | 35233 | United States |
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data is currently available according to the process described on www.clinicalstudydatarequest.com.
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| Childrens National Hospital | Active, not recruiting | Washington D.C. | District of Columbia | 20010 | United States |
| Augusta University Georgia | Recruiting | Augusta | Georgia | 30912 | United States |
|
| East Carolina University | Completed | Greenville | North Carolina | 27834 | United States |
| East Carolina University | Completed | Greenville | North Carolina | 27858 | United States |
| Childrens Hospital of Philadelphia | Active, not recruiting | Philadelphia | Pennsylvania | 19104-4399 | United States |
| Cook Childrens Medical Center | Completed | Fort Worth | Texas | 76104 | United States |
| Novartis Investigative Site | Completed | Brussels | 1000 | Belgium |
| Novartis Investigative Site | Active, not recruiting | Laken | 1020 | Belgium |
| Novartis Investigative Site | Active, not recruiting | Liège | 4000 | Belgium |
| Novartis Investigative Site | Active, not recruiting | Salvador | Estado de Bahia | 41253-190 | Brazil |
| Novartis Investigative Site | Active, not recruiting | Ribeirão Preto | São Paulo | 14051-140 | Brazil |
| Novartis Investigative Site | Active, not recruiting | São Paulo | São Paulo | 01232-010 | Brazil |
| Novartis Investigative Site | Recruiting | Barranquilla | Atlántico | 080020 | Colombia |
| Novartis Investigative Site | Recruiting | Valledupar | Cesar Department | 200001 | Colombia |
| Novartis Investigative Site | Active, not recruiting | Cali | Valle del Cauca Department | 760032 | Colombia |
| Novartis Investigative Site | Active, not recruiting | Montería | 230004 | Colombia |
| Novartis Investigative Site | Completed | Créteil | 94010 | France |
| Novartis Investigative Site | Active, not recruiting | Paris | 75015 | France |
| Novartis Investigative Site | Completed | Paris | 75015 | France |
| Novartis Investigative Site | Active, not recruiting | Heidelberg | 69120 | Germany |
| Novartis Investigative Site | Active, not recruiting | Padova | PD | 35128 | Italy |
| Novartis Investigative Site | Completed | Orbassano | TO | 10043 | Italy |
| Novartis Investigative Site | Recruiting | Beirut | 113-0236 | Lebanon |
| Novartis Investigative Site | Recruiting | Tripoli | 1434 | Lebanon |
| Novartis Investigative Site | Recruiting | Khoudh | 123 | Oman |
| Novartis Investigative Site | Completed | Barcelona | 08035 | Spain |
| Novartis Investigative Site | Active, not recruiting | Madrid | 28009 | Spain |
| Novartis Investigative Site | Withdrawn | Hatay | Antakya | 31101 | Turkey (Türkiye) |
| Novartis Investigative Site | Active, not recruiting | Adana | Saricam | 01330 | Turkey (Türkiye) |
| Novartis Investigative Site | Active, not recruiting | Adana | Yuregir | 01250 | Turkey (Türkiye) |
| ID | Term |
|---|---|
| D000755 | Anemia, Sickle Cell |
| D000098644 | Vaso-Occlusive Crises |
| ID | Term |
|---|---|
| D000745 | Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006453 | Hemoglobinopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| C000614139 | crizanlizumab |
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