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Evaluation of Different Benznidazole Regimens for the Treatment of Chronic Chagas Disease.

NCT03191162 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 238

Last updated 2023-12-19

No results posted yet for this study

Summary

A phase 2 clinical trial to evaluate the the efficacy of different benznidazole regimens (300mg/day for 60 days, 150mg/day for 60 days, and 400mg/day for 15 days) for the treatment of chronic Chagas disease in adult patients. The efficacy is assessed through the proportion of patients with negative parasitaemia measured by Polymerase Chain Reaction (PCR) during the first 12 months after starting treatment. The study will be performed in Spain, Brazil, Argentina and Colombia.

Conditions

  • Chagas Disease
  • Trypanosoma Cruzi Infection

Interventions

DRUG

Benznidazole

To evaluate different regimens of Benznidazole for the treatment of chronic Chagas disease

Sponsors & Collaborators

  • Hospital Universitari Vall d'Hebron Research Institute

    lead OTHER

Principal Investigators

  • Israel Molina, PhD · Hospital Universitario Vall d'Hebron Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-21
Primary Completion
2020-09-21
Completion
2021-03-16

Countries

  • Argentina
  • Brazil
  • Colombia
  • Spain

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 NCT03191162 on ClinicalTrials.gov