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Research & Innovation Programmes
Chagas

FEXI 12

Oral fexinidazole dosing regimens for the treatment of adults with chronic indeterminate Chagas disease

Photo: DNDi
Duration
04/10/2017 - 31/12/2018
Coordinator
Joaquim Gascon
Funded by
DNDi

Phase 2 Randomized, Multicenter, Double-blinded Safety and Efficacy Study

The general objective of this clinical trial is to determine the efficacy and safety of alternative dosing regimens of FEXI in reducing and clearing T. cruzi parasitemia in adult individuals with the chronic indeterminate Chagas Disease, in comparison to historical placebo control.

This is  a double-blind, randomized, prospective, comparative, pharmacokineticpharmacodynamic, and proof-of-concept trial design, with three-parallel groups and historical placebo control. The trial will be conducted in 5 different sites in Spain. The trial will be sufficiently powered to compare the efficacy and safety of each of the dosing regimens of FEXI with historical placebo control. Efficacy and safety will be monitored by an external independent Data Monitoring Committee (DMC) on an ongoing basis. The committee is to include cardiac and liver safety experts, as well as Chagas Disease clinical expertise.

The total duration of patient trial participation will be approximately 14 months.

Our Team

PI

  • Joaquim Gascon Brustenga
    Joaquim Gascon Brustenga

ISGlobal team

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