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Efficacy and Safety of Fexinidazole Compared to Nifurtimox-Eflornithine Combination Therapy (NECT) in Patients With Late-stage Human African Trypanosomiasis (HAT) Due to T.b. Gambiense: Pivotal, Non-inferiority, Multicentre, Randomised, Open-label Study

Trial Profile

Efficacy and Safety of Fexinidazole Compared to Nifurtimox-Eflornithine Combination Therapy (NECT) in Patients With Late-stage Human African Trypanosomiasis (HAT) Due to T.b. Gambiense: Pivotal, Non-inferiority, Multicentre, Randomised, Open-label Study

Status: Completed
Phase of Trial: Phase II/III

Latest Information Update: 22 Jan 2019

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At a glance

  • Drugs Fexinidazole (Primary) ; Eflornithine; Nifurtimox
  • Indications African trypanosomiasis
  • Focus Therapeutic Use
  • Sponsors Drugs for Neglected Diseases Initiative Foundation
  • Most Recent Events

    • 22 Jan 2019 Pharmacokinetic-pharmacodynamic assessment of the hepatic and bone-marrow toxicities from six trials published in the Antimicrobial Agents and Chemotherapy
    • 04 Nov 2017 Primary endpoint (Success or failure at 18 months FU visit) has been met, according to the results published in The Lancet.
    • 04 Nov 2017 Results published in The Lancet.
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