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Novel Use Of Hydroxyurea in an African Region With Malaria

NCT01976416 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 208

Last updated 2018-12-04

Study results available
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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.

Conditions

Interventions

DRUG

Hydroxyurea

DRUG

Placebo

Sponsors & Collaborators

  • Doris Duke Charitable Foundation

    collaborator OTHER

  • Makerere University

    collaborator OTHER

  • Mulago Hospital, Uganda

    collaborator OTHER

  • Children's Hospital Medical Center, Cincinnati

    collaborator OTHER

  • Indiana University

    lead OTHER

Principal Investigators

  • Chandy C. John, M.D. · Indiana University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Months
Max Age
47 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2016-10-31
Completion
2017-11-30

Countries

  • Uganda

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01976416 on ClinicalTrials.gov