NCT05725902CompletedPhase 2
Study of the Effect of Etavopivat on Cerebral Hemodynamic Response in Children With Sickle Cell Disease
A Pilot Study of the Effect of Etavopivat on Cerebral Hemodynamic Response in Children With Sickle Cell Disease
Source: ClinicalTrials.gov · Last updated 8 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 12 (actual)
- First submitted
- 23 Jan 2023
- Start date
- 9 Mar 2024
- Primary completion date
- 9 Mar 2026
- Lead sponsor
- Novo Nordisk A/S
- Diseases
- Sickle cell disease
- NCT number
- NCT05725902
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 12
- From 9 Mar 2024 to the primary completion date, 9 Mar 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- 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
Other illness
- 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
Other
- 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
- Female who is breast feeding or pregnant
Who the study is looking for
- 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
Age in the registry: 12 years to 21 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Emory University, Children's Healthcare of Atlanta Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.