Chagas' Disease (Chronic) Nos Clinical Trial
Official title:
Phase 2 Randomized, Multicenter, Double-blinded Safety and Efficacy Study to Evaluate Oral Fexinidazole Dosing Regimens for the Treatment of Adult Patients With Chronic Indeterminate Chagas Disease
This study focuses on the evaluation of low doses (600 and 1200 mg) and short treatment duration (at 3, 7 and 10 days) of fexinidazole (Fexi) to determine the minimal efficacious and safe dose for the treatment of adult patients with chronic indeterminate Chagas Disease (CD).
Fexi anti-protozoal activity against T. cruzi has been demonstrated by various in vitro and
in vivo studies.
Patients will be randomly assigned to receive one of three different treatment regimen arms
containing either the active drug or matching placebo tablet
Following conclusion of 12 months of follow-up of DNDi-CH-FEXI-001 clinical trial, unblinded
data review showed high sustained parasite clearance rates of FEXI even at the lowest dose
tested (1200 mg 2 weeks), including in patients that received < 3days treatment.
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