CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 208 enrolled
Drug / intervention
Hydroxyurea +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01976416
NCT01976416Phase 3Completed
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Novel Use Of Hydroxyurea in an African Region With Malaria

Indiana University·interventional·Posted Nov 5, 2013·Updated Dec 4, 2018

In Brief

A Phase 3 clinical trial evaluating Hydroxyurea and Placebo for Sickle Cell Anemia and 2 related conditions. Completed, enrolled 208 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSickle Cell Anemia, Sickle Cell Disease, Malaria
CountriesUganda
CollaboratorsDoris Duke Charitable Foundation, Makerere University, Mulago Hospital, Uganda, Children's Hospital Medical Center, Cincinnati

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedNov 5, 2013
Enrollment StartSep 1, 2014
Primary CompletionOct 1, 2016
Study CompletionNov 1, 2017
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 12.7 years ago

Interventions

Hydroxyureadrug

Placebodrug