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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01976416
Other study ID # 2012139
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date September 2014
Est. completion date November 2017

Study information

Verified date November 2018
Source Indiana University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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Study Design


Intervention

Drug:
Hydroxyurea

Placebo


Locations

Country Name City State
Uganda Mulago Hospital Sickle Cell Clinic Kampala

Sponsors (5)

Lead Sponsor Collaborator
Indiana University Children's Hospital Medical Center, Cincinnati, Doris Duke Charitable Foundation, Makerere University, Mulago Hospital, Uganda

Country where clinical trial is conducted

Uganda, 

References & Publications (1)

Opoka RO, Ndugwa CM, Latham TS, Lane A, Hume HA, Kasirye P, Hodges JS, Ware RE, John CC. Novel use Of Hydroxyurea in an African Region with Malaria (NOHARM): a trial for children with sickle cell anemia. Blood. 2017 Dec 14;130(24):2585-2593. doi: 10.1182/ — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Malaria Episodes Malaria is defined as the presence of P. falciparum or P. malariae on the peripheral smear of any child brought in for medical evaluation of fever. P. vivax, P. ovale and P. knowlesi are not known to be present in this region, but if a child is seen with suspected infection with any of these malaria parasites, this will also be recorded as a case of malaria. Incidence will be reported in the number of cases per 100 patient years. 12 months
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