Novel Use Of Hydroxyurea in an African Region With Malaria

• Status: Completed
• Trial end date: 2017-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Indiana University
• Collaborators: Children's Hospital Medical Center, Cincinnati; Doris Duke Charitable Foundation; Makerere University; Mulago Hospital, Uganda
• Treatments: Hydroxyurea

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:

1. Hb <4.0 g/dL

2. Hb <6.0 g/dL AND ARC <100 x 10E9/L

3. Hb <7.0 g/dL AND ARC <80 x 10E9/L

4. Platelets <80 x 10E9/L

5. ANC <1.0 x 10E9/L

• Alanine transaminase (ALT) or creatinine >2 times the upper limit of normal for age

• Blood transfusion within 30 days prior to enrollment