Phase 3
N=208
Novel Use Of Hydroxyurea in an African Region With Malaria
Sickle Cell Anemia · Sickle Cell Disease · Malaria
Bottom Line
View on ClinicalTrials.gov: NCT01976416 ↗Enrolled (actual)
208
Serious AEs
5.8%
Results posted
Oct 2018
Primary outcome: Primary: Number of Malaria Episodes — 5; 7 malaria episodes
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Hydroxyurea (Drug); Placebo (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Indiana University
- Primary completion
- Oct 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Malaria Episodes |
5; 7 | — |
Summary
Multiple studies have shown that hydroxyurea has clinical efficacy in preventing acute painful episodes and reducing the need for blood transfusions in children with sickle cell anemia (SCA), but no study has been conducted in malaria endemic regions of sub-Saharan Africa, the areas with the most children with SCA.
The primary goal of this study is to investigate the safety and efficacy of hydroxyurea for children with SCA in a malaria endemic region within sub-Saharan Africa.
Eligibility Criteria
Inclusion Criteria
- Pediatric subjects with documented sickle cell anemia (HbSS supported by hemoglobin electrophoresis or by peripheral blood smear showing sickled red blood cells)
- Age range of 1.00-3.99 years, inclusive, at the time of enrollment
- Weight at least 5.0 kg at the time of enrollment
- Willingness to comply with all study-related treatments, evaluations, and follow up
Exclusion Criteria
- Known chronic medical condition (e.g., HIV, malignancy, active clinical tuberculosis)
- Severe malnutrition determined by impaired growth parameters as defined by WHO (weight for length/height or weight-for-length/height > 3 z-scores below the median WHO growth standards)
- Pre-existing severe hematological toxicity:
- Hb 2 times the upper limit of normal for age
- Blood transfusion within 30 days prior to enrollment
Data sourced from ClinicalTrials.gov (NCT01976416). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.