deltatrials
Completed PHASE3 INTERVENTIONAL 1-arm NCT04750707

Hydroxyurea Therapy for Neurological and Cognitive Protection in Pediatric Sickle Cell Anemia in Uganda ( BRAINSAFE-II ) (BRAINSAFEII)

Hydroxyurea Therapy for Neurological and Cognitive Protection in Pediatric Sickle Cell Anemia in Uganda: A Single Arm Open Label Trial, BRAIN SAFE II

Sponsor: Columbia University

Interventions Hydroxyurea
Updated 10 times since 2021 Last updated: Apr 15, 2025 Started: Mar 9, 2021 Primary completion: Mar 10, 2025 Completion: Mar 10, 2025
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE3 trial investigates Sickle Cell Anemia in Children and is currently completed. Columbia University leads this study, which shows 10 recorded versions since 2021 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

~Mar 2021 – ~Apr 2021 · 31 days · monthly snapshotNot Yet Recruiting~Apr 2021 – ~Oct 2021 · 6 months · monthly snapshotRecruiting~Oct 2021 – ~Apr 2022 · 6 months · monthly snapshotRecruiting~Apr 2022 – ~Jun 2022 · 2 months · monthly snapshotActive Not Recruiting~Jun 2022 – ~Sep 2023 · 15 months · monthly snapshotActive Not Recruiting~Sep 2023 – ~Jul 2024 · 10 months · monthly snapshotActive Not Recruiting~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotActive Not Recruiting~Sep 2024 – ~Apr 2025 · 7 months · monthly snapshotActive Not Recruiting~Apr 2025 – ~May 2025 · 30 days · monthly snapshotActive Not Recruiting~May 2025 – present · 14 months · monthly snapshotCompleted

Change History

10 versions recorded
  1. May 2025 — Present [monthly]

    Completed PHASE3

    Status: Active Not RecruitingCompleted

  2. Apr 2025 — May 2025 [monthly]

    Active Not Recruiting PHASE3

  3. Sep 2024 — Apr 2025 [monthly]

    Active Not Recruiting PHASE3

  4. Jul 2024 — Sep 2024 [monthly]

    Active Not Recruiting PHASE3

  5. Sep 2023 — Jul 2024 [monthly]

    Active Not Recruiting PHASE3

Show 5 earlier versions
  1. Jun 2022 — Sep 2023 [monthly]

    Active Not Recruiting PHASE3

  2. Apr 2022 — Jun 2022 [monthly]

    Active Not Recruiting PHASE3

    Status: RecruitingActive Not Recruiting

  3. Oct 2021 — Apr 2022 [monthly]

    Recruiting PHASE3

  4. Apr 2021 — Oct 2021 [monthly]

    Recruiting PHASE3

    Status: Not Yet RecruitingRecruiting

  5. Mar 2021 — Apr 2021 [monthly]

    Not Yet Recruiting PHASE3

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Columbia University
  • Emory University
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • Global Health Uganda LTD
  • Makerere University
  • Mulago Hospital, Uganda
  • University of Pittsburgh
Data source: Global Health Uganda LTD

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations