Phase 3
Completed N=208
Novel Use Of Hydroxyurea in an African Region With Malaria
Source: ClinicalTrials.gov NCT01976416 ↗Enrolled (actual)
208
Serious AEs
5.8%
Results posted
Oct 2018
Primary outcomePrimary: Number of Malaria Episodes — 5; 7 malaria episodes
◆ Published Evidence
Highly cited
150citations · ~17 / year
Novel use Of Hydroxyurea in an African Region with Malaria (NOHARM): a trial for children with sickle cell anemia.
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.
Linked Publications (5)
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Novel use Of Hydroxyurea in an African Region with Malaria (NOHARM): a trial for children with sickle cell anemia.
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Perceived benefits and risks of participation in a clinical trial for Ugandan children with sickle cell anemia.
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Novel Use of Hydroxyurea in an African Region With Malaria: Protocol for a Randomized Controlled Clinical Trial.
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Hydroxyurea pharmacokinetics in children with sickle cell anemia across different global populations.
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Angiopoietin-2 is associated with sickle cell complications, including stroke risk, and decreases with hydroxyurea therapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Malaria Episodes |
5; 7 | — |
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) and the linked publication. 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. Informational only — not medical advice.