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Status:

ACTIVE_NOT_RECRUITING

Realizing Effectiveness Across Continents With Hydroxyurea

Lead Sponsor:

Children's Hospital Medical Center, Cincinnati

Collaborating Sponsors:

National Heart, Lung, and Blood Institute (NHLBI)

Conditions:

Sickle Cell Disease

Children

Eligibility:

All Genders

3-10 years

Phase:

PHASE2

Brief Summary

REACH is a prospective, phase I/II open-label dose escalation trial of hydroxyurea for children with confirmed SCA between 3 and 10 years of age. The short-term goal is to obtain critical pilot data r...

Detailed Description

REACH is a prospective, phase I/II open-label dose escalation trial of hydroxyurea for children with confirmed SCA between 3 and 10 years of age. The short-term goal is to obtain critical pilot data r...

Eligibility Criteria

Inclusion

  • Inclusion Criteria
  • Pediatric patients with documented sickle cell anemia (typically HbSS supported by hemoglobin electrophoresis, complete blood count, and peripheral blood smear)
  • In the Original Cohort, age range of 1.00-9.99 years, inclusive, at the time of enrollment (now age 5.5 - 17.5 years); age range 3.0-10.0 years for the New Cohort
  • Weight at least 10.0 kg at the time of enrollment
  • Parent or guardian willing and able to provide written informed consent, with child's verbal assent as per local IRB/Ethics Board requirements
  • Willingness to comply with all study-related treatments, evaluations, and follow-up
  • Exclusion Criteria
  • Known medical condition making participation ill-advised (e.g., acute or chronic infectious disease, HIV, or malignancy)
  • Acute or chronic severe malnutrition determined by impaired growth parameters as defined by WHO (weight for length/height or height for age \>3 z-scores below the median WHO growth standards.
  • Pre-existing severe hematological toxicity (temporary exclusions)
  • Anemia: Hb \<4.0 g/dL
  • Anemia: Hb \<6.0 g/dL with ARC \<100 x 109/L
  • Reticulocytopenia: ARC \<80 x 109/L with Hb \<7.0 g/dL
  • Thrombocytopenia: Platelets \<80 x 109/L
  • Neutropenia: ANC \<1.0 x 109/L
  • Blood transfusion within 60 days before enrollment (temporary exclusion)
  • In the Original Cohort, hydroxyurea use within 6 months before enrollment (temporary exclusion). In the New Cohort, the children should be hydroxyurea naïve, without any prior treatment exposure.

Exclusion

    Key Trial Info

    Start Date :

    October 27 2023

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    October 4 2033

    Estimated Enrollment :

    810 Patients enrolled

    Trial Details

    Trial ID

    NCT06171217

    Start Date

    October 27 2023

    End Date

    October 4 2033

    Last Update

    May 14 2025

    Active Locations (4)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 1 (4 locations)

    1

    Hospital Pediátrico David Bernardino

    Luanda, Angola

    2

    Centre Hospitalier Monkole

    Kinshasa, Democratic Republic of the Congo

    3

    KEMRI/Wellcome Trust Research

    Kilifi, Kenya

    4

    Mbale Regional Hospital

    Mbale, Uganda