Rollover Study for Patients With Sickle Cell Disease Who Have Completed a Prior Novartis-Sponsored Crizanlizumab Study
Novartis Pharmaceuticals · NCT04657822
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 6 mo–100 · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 4
- Target enrollment
- 130
- US sites recruiting
- 2
- Study start
- June 10, 2021
- Record last updated
- June 8, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: Crizanlizumab
Conditions: Sickle Cell Disease
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full 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
Recruiting US locations
University Of Alabama
Birmingham, AL 35233
Site contact: Jeanine Dumas · +1 205 638 2792 · jdumas@uabmc.edu
Augusta University Georgia
Augusta, GA 30912
Site contact: Latanya Bowman · 706-721-2171 · lbowman@augusta.edu
Study contacts (from the official record)
- Novartis Pharmaceuticals · 1-888-669-6682 · novartis.email@novartis.com
- Novartis Pharmaceuticals · +41613241111