Study of Crizanlizumab for Prevention of Silent Cerebral Infarcts in SCA (NCT05334576) | Clinical Trial Compass
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Study of Crizanlizumab for Prevention of Silent Cerebral Infarcts in SCA
United States31 participantsStarted 2022-08-01
Plain-language summary
In this prospective, single-arm, open-label, imaging and treatment study, the investigator will test the hypothesis that crizanlizumab will prevent the progression of silent cerebral infarcts in patients with sickle cell disease. Study participants will undergo brain MRI before initiation of crizanlizumab and at 6 and 30 months after starting crizanlizumab infusions. The crizanlizumab cohort will be compared to a matched, observational cohort of patients not receiving crizanlizumab.
Who can participate
Age range16 Years
SexALL
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Inclusion criteria
✓. Adult participants age 16 and older
✓. Sickle cell disease with confirmation of HbSS, HbSBthal0, HbSC, or HbS thal+ genotype
✓. Per patient's sickle cell provider, patient has an increased risk of a silent cerebral infarcts according to one of the following criteria:
✓. Silent cerebral infarcts visualized on FLAIR MRI within previous two years
✓. Intracranial or extracranial cervical artery vasculopathy
✓. History of overt ischemic or hemorrhagic stroke and Intolerance and/or failure of other therapies to prevent cerebral infarction
✓. Increased severity of sickle cell disease including having between 2 and 10 sickle cell-related pain crises within the preceding 12 months as determined by medical history or by patient's recall (crises should include the occurrence of appropriate symptoms, a visit to a specific medical facility and/or health care professional, and receipt of pain medication).
✓. Increased risk deemed by other objective laboratory and/or imaging results which have been associated with increased risk of cerebral infarction
Exclusion criteria
✕. Current chronic transfusion therapy
✕. Planning for hematopoietic stem cell transplant or cerebral revascularization procedure
✕. Use of other investigational drug within one year of study participation