Phase 2 Sickle Cell Disease Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- A parent, legal guardian, or legal representative has given written permission for the patient to participate, and the patient themselves has also agreed to take part in an age-appropriate way
- The patient is between 12 and 16 years old (inclusive) at the time of screening
- The patient has a confirmed diagnosis of Sickle Cell Disease (SCD), based on past blood test results (no special genetic testing is required)
- The patient has high blood flow speeds in certain brain arteries (measured at 170 cm/s or above on two separate occasions using a special ultrasound test), and has no history of stroke, mini-stroke, or severe blood vessel disease in the brain
- The patient's hemoglobin (a measure of red blood cells) is between 6 and 9 g/dL at screening
- If the patient is already taking a medication called hydroxyurea (HU), the dose must have been stable for at least 90 days before starting the study, with no expected need to change it (confirm with trial site)
- Female patients who could become pregnant must agree to use an acceptable form of birth control and not donate eggs from the start of the study until 90 days after the last dose; male patients must also agree to use acceptable contraception and not donate sperm during this same period
Who may not be able to join:
- Patients who are pregnant or currently breastfeeding
- Patients who have a history of seizures or a seizure disorder
- Patients who have had a stroke, a mini-stroke (TIA), a noticeable neurological weakness, or who show signs of severe blood vessel disease in the brain on scan results
- Patients who have significantly low levels of certain blood cells (white blood cells, platelets, or reticulocytes — confirm with trial site)
- Patients with severely reduced kidney function or who are on ongoing dialysis
- Patients with significant liver problems, based on specific blood test results being too high (confirm with trial site)
- Patients who have a serious active bacterial, fungal, parasitic, or viral infection currently requiring treatment — screening may be delayed until the infection has cleared
- Patients who have HIV
- Patients who have a known active Hepatitis B infection
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Clinical Transparency (dept. 2834), Novo Nordisk A/S
Phone: (+1) 866-867-7178
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
Change in the highest TAMMV in any of the L/R internal carotid artery [ICA] and L/R middle cerebral artery [MCA], whichever is highest, as measured by TCD
Can't join this trial?
Data last synced from ClinicalTrials.gov: 23 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.