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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00123916
Other study ID # BEN01
Secondary ID CONEP-11394
Status Completed
Phase Phase 3
First received
Last updated
Start date November 2004
Est. completion date August 2015

Study information

Verified date February 2020
Source Population Health Research Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Evaluate if benznidazole, an antiparasite drug, given at a dose calculated as 5mg/kg/day for 60 days, now administered as a fixed daily dose of 300mg during 40 to 80 days of treatment - period adjusted according to the patient's body weight to a total minimum dose of 12g (corresponding to 40kg) and a total maximum dose of 24g (corresponding to 80kg) - reduces morbidity and mortality in patients with Chronic Chagas' Cardiomyopathy (CCC).

The BENEFIT study is being conducted by the Population Health Research Institute (in Hamilton, Canada) and the Institute Dante Pazzanese de Cardiologia (Sao Paulo, Brazil) together with a Steering Committee, and an independent Safety Monitoring Board.


Description:

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Study Design


Intervention

Drug:
Benznidazole
Daily po Benznidazole or placebo (weight based) during 40 - 80 days (depending on body weight)
Placebo
a dose calculated as 5mg/kg/day for 60 days, now administered as a fixed daily dose of 300mg during 40 - 80 days of treatment - period adjusted according to the patient's body weight to a total minimum dose of 12g (corresponding to 40kg) and a total maximum dose of 24g (corresponding to 80kg)

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Sponsors (5)

Lead Sponsor Collaborator
Population Health Research Institute Canadian Institutes of Health Research (CIHR), Instituto Dante Pazzanese de Cardiologia, University of Sao Paulo, World Health Organization

Countries where clinical trial is conducted

Argentina,  Bolivia,  Brazil,  Colombia,  El Salvador, 

References & Publications (1)

Marin-Neto JA, Rassi A Jr, Morillo CA, Avezum A, Connolly SJ, Sosa-Estani S, Rosas F, Yusuf S; BENEFIT Investigators. Rationale and design of a randomized placebo-controlled trial assessing the effects of etiologic treatment in Chagas' cardiomyopathy: the BENznidazole Evaluation For Interrupting Trypanosomiasis (BENEFIT). Am Heart J. 2008 Jul;156(1):37-43. doi: 10.1016/j.ahj.2008.04.001. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Composite of First of cardiovascular events: Death, Resuscitated Cardiac Arrest, Sustained VentricularTachycardia, New/worsening Heart Failure, New Pacemaker/ICD, Stroke/TIA or other Embolic Events, Cardiac Transplant. Composite cardiovascular outcome, through study completion, an average of 5 years
Secondary New development of any of the following echo changes, segmental wall motion abnormalities, ventricular aneurysm, reduction in LV ejection fraction >5%, increase in LVDD> 5 mm compared to baseline. through study completion, an average of 5 years
Secondary New 12 lead ECG alterations (complete bundle branch block, fascicular block, advanced atrio-ventricular block, atrial fibrillation, etc). through study completion, an average of 5 years
Secondary Progression of NYHA functional class by at least one category through study completion, an average of 5 years
Secondary New 12 lead electrocardiogram (ECG) alterations (complete bundle branch block; fascicular block, advanced atrio-ventricular block, atrial fibrillation, etc.) through study completion, an average of 5 years
Secondary Progression of New York Heart Association (NYHA) functional class by at least one category through study completion, an average of 5 years
Secondary Evaluation of safety (adverse events: dermatitis, peripheral neuropathy, gastro-intestinal intolerance, leucopenia [2500 x 10^9 L]), tolerance and adherence to treatment through study completion, an average of 5 years
Secondary Determination of the efficacy of benznidazole in patients with Chronic Chagas heart disease based on a 50% reduction in both qualitative and quantitative PCR. Polymerase Chain Reaction study on patient's blood samples and report negativization at the end of treatment, 2Y and final visit. through study completion, an average of 5 years
Secondary Safety and tolerability of benznidazole through study completion, an average of 5 years
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