NCT01966731Active, not recruitingPhase 1/2
Realizing Effectiveness Across Continents With Hydroxyurea (REACH)
REALIZING EFFECTIVENESS ACROSS CONTINENTS WITH HYDROXYUREA (REACH): A PHASE I/II PILOT STUDY OF HYDROXYUREA FOR CHILDREN WITH SICKLE CELL ANEMIA
Source: ClinicalTrials.gov · Last updated 30 Jun 2026
Brief summary (registry, in English)
REACH is a prospective, phase I/II open-label dose escalation trial of hydroxyurea for for pediatric patients with sickle cell anemia (SCA). The short-term goal is to obtain critical pilot data regarding the feasibility, safety, and benefit of hydroxyurea for children with SCA in multiple distinct research settings in Africa. Based on that information, the longer-term goal is to make hydroxyurea more widely available for children with SCA in Africa, particularly those identified with SCA through expanded newborn screening programs.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 635 (actual)
- First submitted
- 4 Oct 2013
- Start date
- 1 Jun 2014
- Primary completion date
- 1 Jul 2018
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Diseases
- Sickle cell disease
- NCT number
- NCT01966731
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 635
- From 1 Jun 2014 to the primary completion date, 1 Jul 2018
- 4 sites in 4 countries
- 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.
Prior treatment
- Blood transfusion within 60 days before enrollment (temporary exclusion)
- Hydroxyurea use within 6 months before enrollment (temporary exclusion)
Other illness
- Known medical condition making participation ill-advised, (e.g., acute or chronic infectious disease, HIV, or malignancy)
Lab values
- Pre-existing severe hematological toxicity (temporary exclusions)
- Anemia: Hb \<4.0 gm/dL
- Anemia: Hb \<6.0 gm/dL with ARC \<100 x 109/L
- Reticulocytopenia: ARC \<80 x 109/L with Hb \<7.0 gm/dL
- Thrombocytopenia: Platelets \<80 x 109/L
- Neutropenia: ANC \<1.0 x 109/L
Age
- 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, as defined in Appendix I)
Who the study is looking for
- Pediatric patients with documented sickle cell anemia (typically HbSS supported by hemoglobin electrophoresis, complete blood count, and peripheral blood smear)
- Age range of 1.00-9.99 years, inclusive, at the time of enrollment
- 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
Age in the registry: 1 year to 10 years · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Pediátrico David Bernardino Coordinator of this site? Confirm its status | Luanda | Angola | Unknown status |
| KEMRI/Wellcome Trust Research Coordinator of this site? Confirm its status | Kilifi | Kenya | Unknown status |
| Ministry of Health Mbale Regional Hospital Coordinator of this site? Confirm its status | Mbale | Uganda | Unknown status |
| Centre Hospitalier Monkole Coordinator of this site? Confirm its status | Kinshasa | Democratic Republic of the Congo | Unknown status |
Related publications
- Growth and puberty in African children with sickle cell anemia treated with hydroxyurea.Blood Adv · 2026 · PMID 41954645
This page is information, not medical advice. Discuss any trial with your doctor.