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Promoting Utilization and Safety of Hydroxyurea Using Precision in Africa

Study acronym: PUSHUP
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated August 20, 2026 (before its estimated September 1, 2026 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Minor Re-verified, no change to tracked fieldsv19
  2. Minor Primary completion date: Jun 30, 2026 to Sep 1, 2026
    • Study completion date: Dec 31, 2026 to Sep 1, 2027
    v18
  3. Minor Primary completion date: Jul 2, 2026 to Jun 30, 2026v17
  4. Minor Primary completion date: Jun 30, 2026 to Jul 2, 2026v16
  5. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Nov 14, 2023 to Nov 15, 2023
    • Site details revised
    v15
Show 13 earlier versionsHide 13 earlier versions
  1. Notable Start date: Oct 1, 2023 to Nov 14, 2023v14
  2. Notable Start date: Sep 1, 2023 to Oct 1, 2023v13
  3. Minor Re-verified, no change to tracked fieldsv12
  4. Minor Primary completion date: Jan 31, 2026 to Jun 30, 2026
    • Study completion date: Jun 30, 2026 to Dec 31, 2026
    • Start date: Aug 15, 2023 to Sep 1, 2023
    v11
  5. Notable Primary endpoints revised (2)
    • Start date: Aug 1, 2023 to Aug 15, 2023
    • Secondary endpoints expanded, about 5 words
    v10
  6. Notable Start date: Jun 1, 2023 to Aug 1, 2023
    • Primary completion date: Dec 31, 2025 to Jan 31, 2026
    • Study completion date: May 31, 2026 to Jun 30, 2026
    v9
  7. Notable Start date: Apr 1, 2023 to Jun 1, 2023v8
  8. Notable Start date: Mar 1, 2023 to Apr 1, 2023v7
  9. Notable Start date: Dec 31, 2022 to Mar 1, 2023v6
  10. Notable Start date: Dec 1, 2022 to Dec 31, 2022
    • Primary endpoints: 1 to 2
    • Eligibility criteria expanded, about 6 words
    v5
  11. Notable Start date: Sep 1, 2022 to Dec 1, 2022v4
  12. Notable Phase: Phase 1 to Phase 3v3 Show 5 more changesShow less
    • Primary completion date: Dec 1, 2024 to Dec 31, 2025
    • Start date: Jul 1, 2022 to Sep 1, 2022
    • Study completion date: Dec 1, 2024 to May 31, 2026
    • Interventions: Hydroxy Urea (Drug) to Hydroxyurea (Drug)
    • Study arms: 3 to 2
  13. Notable Start date: May 1, 2022 to Jul 1, 2022v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05285917
Lead Sponsor Brown University
Collaborators: National Heart, Lung, and Blood Institute (NHLBI), Novartis
Conditions
(from sponsor)
Sickle Cell Anemia in Children, Sickle Cell Disease
Related terms Anemia, Sickle Cell
Enrollment 400 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov