A Multi-centre, Double-blind, Randomised, Parallel-group, Active Controlled Study to Evaluate the Efficacy, Safety and Tolerability of Tafenoquine (SB-252263, WR238605) in Subjects With Plasmodium Vivax Malaria

Trial Profile

A Multi-centre, Double-blind, Randomised, Parallel-group, Active Controlled Study to Evaluate the Efficacy, Safety and Tolerability of Tafenoquine (SB-252263, WR238605) in Subjects With Plasmodium Vivax Malaria

Completed
Phase of Trial: Phase II/III

Latest Information Update: 28 Nov 2017

At a glance

  • Drugs Tafenoquine (Primary) ; Chloroquine; Primaquine
  • Indications Malaria
  • Focus Registrational; Therapeutic Use
  • Acronyms DETECTIVE
  • Sponsors GlaxoSmithKline
  • Most Recent Events

    • 28 Nov 2017 According to a GlaxoSmithKline media release, the company has submitted a New Drug Application (NDA) to the US FDA seeking approval of single-dose tafenoquine for the radical cure (prevention of relapse) of Plasmodium vivax (P. vivax) malaria in patients 16 years of age and older. The NDA submission included data from GATHER and DETECTIVE trials.
    • 12 Jun 2017 Full results will be submitted for publication in peer-reviewed journals, as reported in a GlaxoSmithKline Media Release.
    • 12 Jun 2017 Primary endpoint has been met. (Relapse-free efficacy (Part 2)), as reported in a GlaxoSmithKline Media Release.
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