Phase 3 Sickle Cell Disease Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• You can be male or female.
• You must be 12 years old or older at the time of signing the consent form.
• You must have a confirmed diagnosis of sickle cell disease (such as HbSS, HbSβ0-thalassemia, or a similar type), shown through past or current blood test results.
• You must have had between 1 and 15 painful crises (called vaso-occlusive crises) in the 12 months before the screening visit, and these must be recorded in your medical notes — not just from memory alone.
• Your haemoglobin (a measure of red blood cells in your blood) must fall within a specific range at the screening visit (confirm with trial site for exact values).

Who may not be able to join:

• You have had more than 15 documented painful crises in the past 12 months according to your medical records.
• You have taken a medication called voxelotor (or a similar drug) within the past 28 days, or you are expected to need it during the study.
• You have taken a type of medication called a selectin antagonist (such as crizanlizumab) within a recent period before the study starts, or you are expected to need it during the study.
• You regularly receive scheduled blood transfusions, or you have had 6 or more transfusion events in the past 12 months.
• You have received a blood transfusion in the past 60 days, unless a specific blood test result meets a required level (confirm with trial site).
• You are currently taking, or plan to take, certain medications that strongly affect how the body processes drugs (known as strong CYP3A4 inducers) (confirm with trial site for specific drug names).
• You have used erythropoietin or similar medicines that stimulate blood cell production within the past 28 days, or you are expected to need them during the study.
• You have previously received a stem cell transplant or gene therapy.
• You have significant liver problems, shown by certain blood test results being too high (confirm with trial site for specific values).
• You live in an area where malaria is common but are not able or willing to take malaria prevention medication during the study.
• You have severe kidney problems or are on dialysis (confirm with trial site for specific values).
• You were unable to walk at least 100 metres during a standard walking test at the screening visit.

Important: Always verify eligibility with the trial site directly before applying.