NCT05285917RecruitingPhase 3
Promoting Utilization and Safety of Hydroxyurea Using Precision in Africa
BrUOG 419 - Promoting Utilization and Safety of Hydroxyurea Using Precision in Africa (PUSHUP)
Source: ClinicalTrials.gov · Last updated 20 Aug 2026
Brief summary (registry, in English)
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. Hydroxyurea is a safe and effective once-daily oral medication that has become the standard of care for the treatment of children with SCA in high-resource settings. There is now a growing body of evidence to support the safety and clinical benefits of hydroxyurea for the treatment of SCA in sub-Saharan Africa. The requirement for frequent laboratory monitoring, uncertainties about appropriate, most effective dosing, and the concern for hematologic laboratory toxicities, however, will continue to limit widespread hydroxyurea utilization and real-world effectiveness. The investigators have recently developed and prospectively evaluated an individualized, pharmacokinetics-guided hydroxyurea dosing strategy for children with SCA that has demonstrated optimal clinical and laboratory benefits with minimal toxicity. In this research study, the investigators aim to extend this precision medicine approach to Africa.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 400 (estimated)
- First submitted
- 1 Mar 2022
- Start date
- 15 Nov 2023
- Primary completion date
- 1 Sept 2026
- Lead sponsor
- Brown University
- Diseases
- Sickle cell disease
- NCT number
- NCT05285917
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 400
- From 15 Nov 2023 to the primary completion date, 1 Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- 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
- 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)
Other
- Hydroxyurea use within the past 6 months
- Blood transfusion within the past 6 months (temporary exclusion)
- Pregnancy
Who the study is looking for
- 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)
Age in the registry: 6 months to 12 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Geral dos Cajueiros Coordinator of this site? Confirm its status | Luanda | Angola | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.