Hypoxic Red Blood Cells in Sickle Cell Anemia (NCT06743113) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Hypoxic Red Blood Cells in Sickle Cell Anemia
United States48 participantsStarted 2026-03
Plain-language summary
The overall objective of this study is to evaluate the effectiveness and safety of transfusing hypoxic red blood cells manufactured with the Hemanext ONE system in patients with sickle cell anemia. The Hemanext ONE device was cleared through the De Novo process in September 2023.
Who can participate
Age range7 Years
SexALL
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Inclusion criteria
✓. Male or female at least 7 years of age;
✓. Are able to provide informed consent, and assent as applicable, to participate in the study;
✓. Diagnosis of Sickle Cell Anemia (SCA) (HbSS, HbSβ0 thalassemia) with participation in a chronic transfusion program and have undergone regular transfusions during at least 6 months prior to Screening;
✓. Have had an average interval of at least 14 days between RBC transfusions over the past 6 months;
✓. If on iron chelation therapy, have been on a stable dose for ≥3 months prior to screening;
Exclusion criteria
✕. Are not exclusively transfused at the site;
✕. Have a diagnosis of HbSC disease, HbSβ+ thalassemia or another SCD variant (excluding HbSS and HbSβ0 thalassemia)
✕. Are routinely transfused with washed, packed RBC units;
✕. Have received hemoglobin inducers (e.g. erythropoietin) in the 30 days prior to Screening;
✕. Are currently being evaluated for gene therapy;
✕. Have any clinically significant pulmonary, cardiovascular, endocrine, hepatic, gastrointestinal, renal, infectious, immunological (including significant allo- or auto-immunization) disease, considered not adequately controlled prior to the study;
✕
What they're measuring
1
%HbA Rate of Decline
Timeframe: Through study completion, an average of 14 months