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Phase II Efficacy Study of Artefenomel & Piperaquine in Adults & Children With P. Falciparum Malaria.

NCT02083380 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 448

Last updated 2017-03-10

Study results available
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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.

Conditions

  • Uncomplicated Plasmodium Falciparum Malaria

Interventions

DRUG

Artefenomel 800mg: piperaquine 640mg

Active, loose combination

DRUG

Artefenomel 800mg: piperaquine 960mg

Active, loose combination

DRUG

Artefenomel 800mg: piperaquine 1440mg

Active, loose combination

Sponsors & Collaborators

  • Medicines for Malaria Venture

    lead OTHER

Principal Investigators

  • Fiona Macintyre, PhD · Medicines for Malaria Venture

  • Michael Ramharter, MD · CERMEL (Centre de Recherches Médicale de Lambaréné)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2015-10-31
Completion
2015-11-30

Countries

  • Benin
  • Burkina Faso
  • Democratic Republic of the Congo
  • Gabon
  • Mozambique
  • Uganda
  • Vietnam

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02083380 on ClinicalTrials.gov