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BENDITA BEnznidazole New Doses Improved Treatment and Associations

NCT03378661 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 210

Last updated 2017-12-20

No results posted yet for this study

Summary

Recent scientific advances have provided further impetus to develop new therapeutic approaches for Chagas Disease (CD) using different doses and duration of BZN, as well as combinations directed at multiple therapeutic targets to improve treatment response and tolerability and reduce the potential for development of resistance.

This project focuses on the proof-of-concept evaluation of improved treatment regimens of BZN, with the assessment of new BZN-sparing regimens in monotherapy and in combination with E1224.

Conditions

  • Chagas Disease

Interventions

DRUG

Benznidazole

Benznidazole tablet

DRUG

E1224

E1224 capsules

DRUG

E1224 Placebo

E1224 matched placebo capsules

DRUG

Benznidazole Placebo

Benznidazole matched placebo tablets

Sponsors & Collaborators

  • Drugs for Neglected Diseases

    lead OTHER

Principal Investigators

  • Faustino Torrico, PhD · Plataforma de Atención Integral de Pacientes con Enfermedad de Chagas. Cochabamba, Bolivia.

  • Joaquim Gascón, PhD · Centro de Salud Internacional, Hospital Clínico de Barcelona CRESIB - Centre de Recerca en Salut Internacional de Barcelona Barcelona, España.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2018-01-28
Completion
2018-07-27

Countries

  • Bolivia

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 NCT03378661 on ClinicalTrials.gov