NCT03587766

Oral Fexinidazole Dosing Regimens for the Treatment of Adults With Chronic Indeterminate Chagas Disease

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Drugs for Neglected Diseases · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Chagas' Disease (Chronic) Nos

Interventions

Type	Name	Description
DRUG	Fexinidazole	Drug: fexinidazole (FEXI)
DRUG	Placebo Oral Tablet	Drug: fexinidazole

Timeline

• Start date: 2017-11-13
• Primary completion: 2018-12-19
• Completion: 2019-08-28
• First posted: 2018-07-16
• Last updated: 2020-09-23

Locations

1 site across 1 country: Spain