NCT04657822 Rollover Study for Patients With Sickle Cell Disease Who Have Completed a Prior Novartis-Sponsored Crizanlizumab Study
| NCT ID | NCT04657822 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Novartis Pharmaceuticals |
| Condition | Sickle Cell Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 130 participants |
| Start Date | 2021-06-10 |
| Primary Completion | 2031-06-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 130 participants in total. It began in 2021-06-10 with a primary completion date of 2031-06-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: 1. 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 2. 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 3. 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: 1. Patient had permanently discontinued from crizanlizumab study treatment in the parent study before the parent study completion 2. 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 3. Concurrent participation in any other investigational clinical trial other than the parent study or plan to participate in any other investigational clinical trial 4. Pregnant or nursing women 5. Women of childbearing potential who are unwilling to be on highly effective contraceptives during dosing and until 15 weeks after stopping treatment with crizanlizumab 6. SCD patients who do not meet parent study protocol criteria to continue with crizanlizumab
Contact & Investigator
Novartis Pharmaceuticals
STUDY DIRECTOR
Novartis Pharmaceuticals
Frequently Asked Questions
Who can join the NCT04657822 clinical trial?
This trial is open to participants of all sexes, aged 6 Months or older, up to 100 Years, studying Sickle Cell Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04657822 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT04657822 currently recruiting?
Yes, NCT04657822 is actively recruiting participants. Contact the research team at novartis.email@novartis.com for enrollment information.
Where is the NCT04657822 trial being conducted?
This trial is being conducted at Birmingham, United States, Washington D.C., United States, Augusta, United States, Greenville, United States and 11 additional locations.
Who is sponsoring the NCT04657822 clinical trial?
NCT04657822 is sponsored by Novartis Pharmaceuticals. The principal investigator is Novartis Pharmaceuticals at Novartis Pharmaceuticals. The trial plans to enroll 130 participants.
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