drugset / Trial / NCT03128515
Optimizing Hydroxyurea Therapy in Children With SCA In Malaria Endemic Areas
Phase 3
Completed
187 enrolled
Indiana University
Children's Hospital Medical Center, Cincinnati · collabDoris Duke Charitable Foundation · collabMakerere University · collabMulago Hospital, Uganda · collab
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2017-07-26
- Primary completion
- 2019-04-07
- Completion
- 2020-01-28
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Hydroxyurea | Other / unclassified | 20 mg/kg | Oral |
| Subject | Hydroxyurea | Other / unclassified | 25 mg/kg | Oral |
| Subject | Hydroxyurea | Other / unclassified | 30 mg/kg | Oral |