At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomised Phase IIb Study of Efficacy, Safety, Tolerability & Pharmacokinetics of a Single Dose Regimen of Artefenomel (OZ439) in Loose Combination With Piperaquine in Adults and Children With Uncomplicated Plasmodium Falciparum Malaria.
In Brief
A Phase 3 clinical trial evaluating Artefenomel 800mg: piperaquine 640mg, Artefenomel 800mg: piperaquine 960mg, and 1 other intervention for Uncomplicated Plasmodium Falciparum Malaria. Completed, enrolled 448 participants across 9 sites in 7 countries.
Detailed 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.
Study Details
Timeline
Interventions
Active, loose combination
Active, loose combination
Active, loose combination