Study of the Effect of Etavopivat on Cerebral Hemodynamic Response in Children With Sickle Cell Disease
Completed · Phase 2
Conditions studied: Sickle Cell Disease
In brief
An open-label, single arm study in patients 12 to 21 years of age with SCD to evaluate the effects of etavopivat on cerebral and muscle hemodynamics.
Key facts
- Study ID
- NCT05725902
- Run by
- Novo Nordisk A/S
- People needed
- 12
- Starts
- 2024-03-09
- Expected to finish
- 2026-03-09
- Last updated by the study team
- 2026-04-08
Who can join
Age: 12 and older, up to 21. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Homozygous hemoglobin SS (HbSS) or hemoglobin S/beta0 thalassemia (HbS/β0 thal)
- Hemoglobin (Hb): Hb ≤ 9.0 g/dL at baseline
- Concomitant hydroxyurea (HU) therapy is allowed if the dose has been stable for at least 3 months with no anticipated need for dose adjustments during the study and no sign of hematological toxicity
You may not qualify if…
- Any one of the following requiring a medical facility visit within 14 days prior to signing the informed consent form:
- Vaso-occlusive crisis (VOC)
- Acute chest syndrome (ACS)
- Splenic sequestration
- Dactylitis
- Requires chronic transfusion therapy
- Abnormal TCD in the last 12 months
- RBC transfusion within 60 days of screening
- Severe renal dysfunction at the Screening Visit or on chronic dialysis
- Hepatic dysfunction
- Clinically relevant cardiac or pulmonary disease- e.g., congenital heart defect, uncompensated heart failure, or any unstable cardiac condition, arrhythmic heart condition, pulmonary fibrosis, pulmonary hypertension
- Major surgery involving the stomach or small intestine
- Chemotherapy or radiation within the past 2 years
- History of overt clinical stroke within previous 2 years or any history of an intracranial hemorrhage
- Clinically significant bacterial, fungal, parasitic, or viral infection currently receiving or that will require therapy
- Female who is breast feeding or pregnant
Where it is running
- Emory University Children's Healthcare of Atlanta — Atlanta, Georgia, United States
Full record on ClinicalTrials.gov
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