Chagas

FEXI 12

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

Foto: DNDi

Durada: 04/10/2017 - 31/12/2018
Coordinador: Joaquim Gascon
Finançadors: 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.

PI

Joaquim Gascon Brustenga

ISGlobal team

Maria Jesús Pinazo Delgado
Elisabeth Jesus Posada Diago
Cristina Ballart Associated Researcher
Carme Subirà Tècnica de recerca
Alba Abras Postdoctoral Fellow
Julio Alonso Padilla Assistant Research Professor, Director of the Chagas Initiative
Eva Muñoz Tècnica de laboratori
Irene Losada Medical Research Fellow, Chagas Initiative Coordinator
Glady Carranza Rivera
MONICA SOLANES Assessor de Cartera
Diana Barrios Tècnic de Suport Científic - Laboratori

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

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