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Prospective Study of a Pediatric Nifurtimox Formulation for Chagas' Disease

Chagas Disease Clinical Trial

Official title:
Prospective, Historically Controlled Study to Evaluate the Efficacy and Safety of a New Pediatric Formulation of Nifurtimox in Children Aged 0 to 17 Years With Chagas' Disease

Clinical Trial Summary

The study consists of two parts. Part I (CHICO) was designed to develop a better understanding of the efficacy, safety and pharmacokinetics of nifurtimox in children with a diagnosis of Chagas' disease (Trypanosoma cruzi infection) using pediatric formulations. Part II (CHICO SECURE) was designed at request of the FDA to assess the incidence of sero-negative conversion in children with diagnosis of Chagas' disease treated with nifurtimox.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02625974
Study type Interventional
Source Bayer
Contact
Status Completed
Phase Phase 3
Start date January 27, 2016
Completion date August 10, 2021
View Details
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