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Population Pharmacokinetics Study of Benznidazole in Children With Chagas'Disease

NCT01549236 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2018-06-25

No results posted yet for this study

Summary

The purpose of this study is to describe the population pharmacokinetics parameters of benznidazole in children with acute or early chronic indeterminate form of Chagas Disease.

Conditions

  • Chagas' Disease

Interventions

DRUG

Benznidazole 12,5mg or 100mg

All 80 subjects recruited into the study will receive treatment with: \- Benznidazole (Laboratório Farmacêutico do Estado de Pernambuco -LAFEPE - Recife - Brazil; tablet 12.5mg or 100mg), 7.5 mg/Kg/day PO (actual range of 5.5-8.5 mg/Kg/d), divided in two daily doses, for 60 days.

Sponsors & Collaborators

  • LAT Research

    collaborator OTHER

  • Drugs for Neglected Diseases

    lead OTHER

Principal Investigators

  • Jaime Altcheh, MD · Argentina: FIPEC Foundation (Fundación para el Estudio de las Infecciones Parasitarias y Enfermedad de Chagas

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Day
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2012-08-31
Completion
2012-10-31

Countries

  • Argentina

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01549236 on ClinicalTrials.gov