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A Randomized, Open-label, Multicenter Study to Compare Efficacy, Safety and Tolerability of KLU156 With Coartem® in the Treatment of Uncomplicated Plasmodium Falciparum Malaria in Adults and Children ≥ 5 kg Body Weight Followed by an Extension Phase With Repeated KLU156 Treatment

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A Randomized, Open-label, Multicenter Study to Compare Efficacy, Safety and Tolerability of KLU156 With Coartem® in the Treatment of Uncomplicated Plasmodium Falciparum Malaria in Adults and Children ≥ 5 kg Body Weight Followed by an Extension Phase With Repeated KLU156 Treatment

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 07 Jan 2025

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At a glance

  • Drugs KLU-156 (Primary) ; Artemether/lumefantrine
  • Indications Falciparum malaria
  • Focus Registrational; Therapeutic Use
  • Acronyms KALUMA
  • Sponsors Novartis Pharmaceuticals

    • Most Recent Events

    • 13 Mar 2024 Status changed from not yet recruiting to recruiting.
    • 15 Jan 2024 Planned End Date changed from 6 Nov 2026 to 11 Aug 2027.
    • 15 Jan 2024 Planned primary completion date changed from 29 Nov 2024 to 7 Jul 2025.

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