Phase II Efficacy Study of Artefenomel & Piperaquine in Adults & Children With P. Falciparum Malaria.
Status:
Completed
Trial end date:
2015-11-01
Target enrollment:
Participant gender:
Summary
A randomised, double-blind single-dose study to determine the efficacy, safety, tolerability
and pharmacokinetics of OZ439 (artefenomel) in combination with piperaquine (PQP) in patients
> 0.5 years and <= 70 years of age with uncomplicated Plasmodium falciparum malaria in Africa
and Asia (Vietnam).
Interim analyses for futility were planned. Adults and children will be included through
progressive step-down in age following safety review by an independent safety monitoring
board (ISMB).
If the study were to meets its efficacy objectives, this will inform dose setting for Phase
III studies.