At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 80 enrolled
Drug / intervention
Benznidazole 12,5mg or 100mgdrug
Likely dose
Benznidazole 12,5mg or 100mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Population Pharmacokinetics Study of Benznidazole in Children With Chagas'Disease
In Brief
A Phase 4 clinical trial evaluating Benznidazole 12,5mg or 100mg for Chagas' Disease. Completed, enrolled 80 participants across 3 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChagas' Disease
CountriesArgentina
CollaboratorsLAT Research
Timeline
Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartMay 2011
First PostedMar 2012
Primary CompletionAug 2012
Study CompletionOct 2012
TodayJul 2026
First PostedMar 9, 2012
Enrollment StartMay 1, 2011
Primary CompletionAug 1, 2012
Study CompletionOct 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 14.3 years ago
Interventions
Benznidazole 12,5mg or 100mgdrug
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.