Phase 2 Sickle Cell Disease Trial, Recruiting

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

Who might be able to join this trial:

For people with sickle cell disease genotypes HbSS or Sβ0 thalassemia, at least one of the following must apply:

• A history of abnormal blood flow measurements in the brain's arteries (measured by a special ultrasound test), recorded on at least two separate occasions
• A history of a stroke or silent stroke of a certain size, seen on a brain MRI scan
• A history of two or more episodes of acute chest syndrome (a serious lung complication of sickle cell disease) at any point in their lifetime
• A history of three or more severe sickle cell pain crises in their lifetime that needed treatment with strong pain medication (such as opioids) given in a hospital or clinic
• A history of any hospital stay for sickle cell pain or acute chest syndrome while already taking hydroxyurea (a common sickle cell medication)
• A history of two or more episodes of priapism (a painful, prolonged erection lasting 4 hours or more, or one that needed emergency medical care)
• Currently receiving regular red blood cell transfusions — at least 8 in the past 12 months
• At least two episodes of the spleen trapping red blood cells (called splenic sequestration), needing a blood transfusion or spleen removal, after at least one such episode

For people with other sickle cell genotypes (HbSC or Sβ+ thalassemia), at least one of the following must apply:

• A history of a significant stroke
• A history of two or more episodes of acute chest syndrome in the 2 years before joining the trial
• A history of three or more severe sickle cell pain crises in the year before joining the trial, needing strong pain medication in a hospital or clinic
• A history of any hospital stay for sickle cell pain or acute chest syndrome while already taking hydroxyurea
• A history of two or more episodes of priapism (lasting 4 hours or more, or needing emergency medical care)
• Currently receiving regular red blood cell transfusions — at least 8 in the past 12 months
• At least two episodes of splenic sequestration needing a blood transfusion or spleen removal, after at least one such episode

Who may not be able to join:

• People with a life expectancy of less than 6 months
• People who are pregnant or breastfeeding
• People who have an uncontrolled bacterial, viral, or fungal infection in the month before starting treatment, or who currently have a fever or suspected infection that has not yet resolved
• People who are HIV positive, or who have active Hepatitis B or C, confirmed by blood tests
• People with certain abnormal liver test results showing the liver is not functioning well enough (confirm with trial site)
• People with certain heart function problems, where the heart is not pumping effectively enough, as measured by an echocardiogram (heart ultrasound)
• People whose kidneys are not filtering blood efficiently enough (confirm with trial site for specific thresholds)
• People with reduced lung capacity below a certain level, or low blood oxygen levels at rest
• People who have developed antibodies against donor red blood cells (a complication that can arise from past blood transfusions), or whose blood type is incompatible with the donor's in a specific way

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