Optimizing Hydroxyurea Therapy in Children With SCA In Malaria Endemic Areas
Status:
Completed
Trial end date:
2020-01-28
Target enrollment:
Participant gender:
Summary
The Novel use Of Hydroxyurea in an African Region with Malaria (NOHARM) study is the first
placebo-controlled randomized clinical trial of hydroxyurea treatment in a malaria endemic
region. NOHARM has now achieved full enrollment; all children have completed the blinded
portion of the protocol and are in the open-label study treatment portion.
This extension study of maximum tolerated dose (MTD), addresses the next critical set of
questions about the optimal dosing and monitoring of hydroxyurea treatment for children with
SCA in low-resource settings. By providing guidance about optimal hydroxyurea treatment, the
NOHARM MTD Study will directly inform policies that can transform the health of African
children living with SCA.
Phase:
Phase 3
Details
Lead Sponsor:
Indiana University
Collaborators:
Children's Hospital Medical Center, Cincinnati Doris Duke Charitable Foundation Makerere University Mulago Hospital, Uganda