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Etiologic Treatment With Benznidazole in Adult Patients With Chronic Chagas Disease. A Randomized Clinical Trial

NCT02386358 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 910

Last updated 2015-03-11

No results posted yet for this study

Summary

The purpose of this study is:

1. -to determine whether benznidazole (BZN) will be able to modify the natural evolution of chronic Chagas disease in adult patients by means of a randomized, double-blind clinical trial (RCT).

Also:
2. -to validate therapeutic efficacy with new methods, such as recombinant antigen F29 of Trypanosoma cruzi visualized by conventional ELISA, in the context of the RCT compared with conventional serology (CS)
3. -to develop the real-time polymerase chain-reaction (RT-PCR) to quantify the parasite load as an early therapeutic effect.
4. to determine the potential of such serological and parasitological methods as predictors of therapeutic effect or failure.

Conditions

  • Chagas Disease

Interventions

DRUG

Benznidazole

Benznidazole at a dose 5 mg/Kg/day until 60 days have been completed or development of non-acceptable toxicity-

DRUG

Placebo

Placebo at a dose 5 m/Kg/day until 60 days

Sponsors & Collaborators

  • National Council of Scientific and Technical Research, Argentina

    collaborator OTHER_GOV

  • Pan American Health Organization

    collaborator OTHER

  • Becas Carrillo Oñativia, Ministerio de Salud, Argentina

    collaborator UNKNOWN

  • Drugs for Neglected Diseases

    collaborator OTHER

  • Instituto Nacional de Parasitologia Dr. Mario Fatala Chaben

    lead OTHER_GOV

Principal Investigators

  • Adellina R Riarte, MD · Chief of Clinical, Pathology and Treatment Department

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1999-03-31
Primary Completion
2012-12-31
Completion
2013-04-30

Countries

  • Argentina

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Entities

Drugs

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 NCT02386358 on ClinicalTrials.gov