Using Hydroxyurea to Treat Sickle Cell Anemia in Children in Africa
BrUOG 419 - Promoting Utilization and Safety of Hydroxyurea Using Precision in Africa (PUSHUP)
PHASE3 · Brown University · NCT05285917
This study is testing if hydroxyurea can safely help children with sickle cell anemia in Africa feel better and improve their treatment options.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 6 Months to 12 Years |
| Sex | All |
| Sponsor | Brown University (other) |
| Locations | 1 site (Luanda) |
| Trial ID | NCT05285917 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and efficacy of hydroxyurea in treating sickle cell anemia in children aged 6 months to 12 years in Luanda, Angola. The study aims to implement a precision medicine approach by utilizing individualized dosing calculations and limited laboratory monitoring to improve treatment accessibility. By establishing evidence-based guidelines for hydroxyurea use in sub-Saharan Africa, the trial seeks to enhance the standard of care for children suffering from this condition. The trial will involve 400 participants and aims to address the barriers to hydroxyurea utilization in low-resource settings.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 6 months to 12 years diagnosed with sickle cell anemia.
Not a fit: Patients with severe hematologic toxicity or those who have used hydroxyurea or received blood transfusions in the past 6 months may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve the survival and quality of life for children with sickle cell anemia in sub-Saharan Africa.
How similar studies have performed: Other studies have shown promising results with hydroxyurea in treating sickle cell anemia, but this approach is tailored specifically for low-resource settings and may provide novel insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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) Exclusion Criteria: * 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; hemoglobin \<7 AND ARC \<80 x10\^9/L (temporary exclusion)
Where this trial is running
Luanda
- Hospital Geral dos Cajueiros — Luanda, Angola (RECRUITING)
Study contacts
- Principal investigator: Patrick T McGann, MD, MS — Rhode Island Hospital and Hasbro Children's Hospital
- Study coordinator: BrUOG
- Email: BrUOG@brown.edu
- Phone: 401-863-3000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Sickle Cell Anemia in Children, Sickle Cell Disease