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Tests treatment safety and results for Sickle Cell Anemia in Children
Official title Promoting Utilization and Safety of Hydroxyurea Using Precision in Africa
ClinicalTrials.gov ID: NCT05285917
What this study is testing
What is Hydroxyurea?
Hydroxyurea is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for sickle cell anemia in children.
Also referred to as Hydrea, Droxia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Sickle cell anemia (SCA) is among the world's most common and devastating blood disorders, affecting more than 300,000 newborns per year. Most infants with SCA are born in the low-resource settings of sub- Saharan Africa, where an estimated 50-90% will die before 5 years of age due to lack of early diagnosis and appropriate care.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 12
You may be able to join if
- Diagnosis of sickle cell anemia (HbSS or HbS/B0-thalassemia)
- Age 6 months- 12 years of age at enrollment
- Parent or guardian willing and able to provide written or informed consent
- Weight ≥ 7.5 kg (temporary exclusion)
You likely can't join if
- Splenomegaly with evidence of hypersplenism as defined by platelet count \<150,000, hemoglobin \<5 g/dL or absolute neutrophil count \<1.0 x10\^9/L
- Hydroxyurea use within the past 6 months
- Blood transfusion within the past 6 months (temporary exclusion)
- Pregnancy
- Pre-existing severe hematologic toxicity, as defined by platelet count \<80,000, hemoglobin \<4 regardless of ANC; hemoglobin \<6 AND ARC \<100...
The study team makes the final eligibility decision.
Where it's taking place
- Luanda, Angola
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 months to 12 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Luanda, Angola. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.