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Chagas DiseasePhase 3BENEFITNCT00123916

BENEFIT: Evaluation of the Use of Antiparasital Drug (Benznidazole) in the Treatment of Chronic Chagas' Disease

A Phase 3 study testing Benznidazole in people with Chagas Disease and Trypanosomiasis, run by Population Health Research Institute at 47 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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… Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Chagas Disease, Trypanosomiasis, Heart Disease
What is being tested?
Benznidazole
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
2,854 participants
Where
47 sitesin 5 countries
Study dates
Nov 2004to Aug 2015
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Consenting patients (between 18 and 75 years of age) with serological evidence of Chagas infection (any combination of 2 positive tests) and that have one or more of the following:
  • Abnormal electrocardiogram with at least two components (complete RBBB or LBBB; left anterior or posterior fascicular block; ventricular premature beat; first degree atrioventricular [AV] block; Mobitz type I AV block; sinus bradycardia; primary ST-T changes; abnormal Q waves; low voltage QRS; or atrial fibrillation);
  • Abnormal ECG (Mobitz type II, advanced or third degree AV block);
  • Increased cardiothoracic ratio (> 0.50);
  • Complex ventricular arrythmias on 24 hour ambulatory ECG monitoring;
  • Evidence of regional wall motion abnormality or reduced global left ventricular systolic function or increased left ventricular and diastolic diameter on 2D-Echo.

Who cannot join

  • Patients will be excluded if having:
  • NYHA heart failure class IV or decompensated heart failure
  • Evidence of concomitant coronary artery disease (CAD) or other etiology of dilated cardiomyopathy
  • Previous treatment with antitrypanosomal agents or an accepted indication for antiparasitic therapy
  • Inability to comply with follow-up visits
  • History of severe alcohol abuse within 2 years
Show all 10Show fewer
  • Known chronic renal or hepatic insufficiency or hepatic insufficiency
  • Pregnancy or breast feeding
  • Megaesophagus with swallowing impairment
  • Other severe disease significantly curtailing life expectancy

Trial locations and contacts

47 sites in 5 countries.

47 sites in 5 countries

Brazil25 sites

  • BENEFIT Investigational Site

    Brasília, Brazilian Federal District, 70658-700

  • BENEFIT Investigational Site

    Campinas, São Paulo, 13059-740

  • BENEFIT Investigational Site

    Carmo, Belo Horizonte, 30130-690

  • BENEFIT Investigational Site

    Curitiba, Paraná, 80060-900

  • BENEFIT Investigational Site

    Goiânia, Goiás, 74110-010

  • BENEFIT Investigational Site

    Goiânia, Goiás, 74110-020

  • BENEFIT Investigational Site

    Goiânia, Goiás, 74605-050

  • BENEFIT Investigational Site

    Pelotas, Rio Grande do Sul, 96015-290

  • BENEFIT Investigational Site

    Recife, Pernambuco, 50100-130

  • BENEFIT Investigational Site

    Ribeirão Preto, São Paulo, 14048-900

  • BENEFIT Investigational Site

    Rio de Janeiro, 21040-360

  • BENEFIT Investigational Site

    Rio de Janeiro, 21941-913

  • BENEFIT Investigational Site

    Salvador, Bahaia, 40050-410

  • BENEFIT Investigational Site

    Salvador, Bahaia, 40110-909

  • BENEFIT Investigational Site

    Salvador, Bahaia, 40425-060

  • BENEFIT Investigational Site

    São José do Rio Preto, São Paulo, 15015-210

  • BENEFIT Investigational Site

    São José do Rio Preto, São Paulo, 15090-000

  • BENEFIT Investigational Site

    São Paulo, 01417 010

  • BENEFIT Investigational Site

    São Paulo, 04012-909

  • BENEFIT Investigational Site

    São Paulo, 05403-000

  • BENEFIT Investigational Site

    São Paulo, 05403-901

  • BENEFIT Investigational Site

    Uberaba, Minas Gerais, 38010-160

  • BENEFIT Investigational Site

    Uberlândia, Minas Gerais, 38025-440

  • BENEFIT Investigational Site

    Uberlândia, Minas Gerais, 38400-299

  • BENEFIT Investigational Site

    Votuporanga, São Paulo, 15500-003

Other trials in Brazil

Argentina18 sites

  • BENEFIT Investigational Site

    Anatuya, Santiago del Estero Province, 3760

  • BENEFIT Investigational Site

    Belen de Escobar, Buenos Aires, 1753

  • BENEFIT Ivestigational Site

    Buenos Aires, Apital Federal, 3556

  • BENEFIT Investigational Site

    Buenos Aires, Buenos Aires F.D., 1063

  • BENEFIT Investigational Site

    Buenos Aires, General Rodríguez Partido

  • BENEFIT Investigational Site

    Buenos Aires

  • BENEFIT Investigational Site

    Catamarca, Catamarca Province

  • BENEFIT Investigational Site

    Charata, Chaco Province, H3730AVI

  • BENEFIT Investigational Site

    Corrientes, Rosario, Santa Fe, 3400

  • BENEFIT Investigational Site

    Isidro Casanova, Buenos Aires, 1282

  • BENEFIT Investigational Site

    Paraná, Entre Ríos Province, 3100

  • BENEFIT Investigational Site

    Rosario, Santa Fe Province, 2000

  • BENEFIT Investigational Site

    Salta, A4406CLA

  • BENEFIT Investigational Site

    San Juan, Buenos Aires, 1625

  • BENEFIT Investigational Site

    San Salvador de Jujuy, Jujuy Province, 4600

  • BENEFIT Investigational Site

    Santiago del Estero, Sgo. Del Estero, 4200

  • BENEFIT Investigational Site

    Santiago Del Estero, Buenos Aires, 4200

  • BENEFIT Investigational Site

    Santiago Del Estero, Buenos Aires, 5400

Other trials in Argentina

Colombia2 sites

  • BENEFIT Investigational Site

    Bogotá, Bogota D.C.

  • BENEFIT Investigational Site

    San Gil, Santander Department

Other trials in Colombia

Bolivia1 site

  • BENEFIT Investigational Site

    Tupiza, Potosí Department

Other trials in Bolivia

El Salvador1 site

  • BENEFIT Ivestigational Site

    San Salvador

Other trials in El Salvador

About this study

Official title: Benznidazole Evaluation for Interrupting Trypanosomiasis - The BENEFIT Trial

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.

Read the detailed description

A randomized double-blind controlled clinical trial investigating the role of benznidazole in patients with chronic Chagas' heart disease.

Chagas disease has 3 phases: acute, undetermined and chronic phases. There are no clinical trials up to date that have investigated the use of antiparasitic drugs in patients that are in the chronic phase.

This study will evaluate the efficacy and safety of benznidazole (an antiparasitic drug) in patients with chronic Chagas' heart disease. 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). It will be developed in 49 study centres in Argentina, Bolivia,Brazil,Colombia, and El Salvador - countries with high incidence of Chagas Disease.

The Pilot study is evaluating if benznidazole is effective in producing parasitic cure (PCR negativization or reducing parasitic load) in chronic Chagas Disease as well as assessing the feasibility of conducting a large trial in chronic Chagas Disease in South America.

Being tested
Benznidazole, Placebo
Keywords
Chagas Disease, Trypanosomiasis, Benznidazole, Chronic Heart disease, Trypanosoma Cruzi
Medical subject headings
Chagas Disease, Trypanosomiasis, Heart Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BenznidazoleDrug

    Also called Rochagan/LaFepe

    Daily po Benznidazole or placebo (weight based) during 40 - 80 days (depending on body weight)

  • PlaceboDrug

    Also called Rochagan/LaFepe

    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)

Study groups in NCT00123916
Study groupRoleWhat they receive
BenznidazoleExperimental40 - 80 days (according to body weight) treatment with benznidazol
Receives: Drug: Benznidazole
PlaceboPlacebo comparator40 - 80 days (according to body weight) treatment with matching placebo
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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,

    Measured: through study completion, an average of 5 years

Secondary outcomes (8)

  1. 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.

    Measured: through study completion, an average of 5 years

  2. New 12 lead ECG alterations (complete bundle branch block, fascicular block, advanced atrio-ventricular block, atrial fibrillation, etc).

    Measured: through study completion, an average of 5 years

  3. Progression of NYHA functional class by at least one category

    Measured: through study completion, an average of 5 years

  4. New 12 lead electrocardiogram (ECG) alterations (complete bundle branch block; fascicular block, advanced atrio-ventricular block, atrial fibrillation, etc.)

    Measured: through study completion, an average of 5 years

  5. Progression of New York Heart Association (NYHA) functional class by at least one category

    Measured: through study completion, an average of 5 years

  6. Evaluation of safety (adverse events: dermatitis, peripheral neuropathy, gastro-intestinal intolerance, leucopenia [2500 x 10^9 L]), tolerance and adherence to treatment

    Measured: through study completion, an average of 5 years

  7. 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.

    Measured: through study completion, an average of 5 years

  8. Safety and tolerability of benznidazole

    Measured: through study completion, an average of 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jul 2005 (estimated)
  2. Study startNov 2004
  3. Primary completionJul 2015
  4. Study completionAug 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
2,854 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00123916
Sponsor's protocol ID
BEN01
Other IDs
CONEP-11394
Acronym
BENEFIT
Status last verified
Feb 2020
First submitted
21 Jul 2005
Last updated
3 Mar 2020
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 18585495

  • Morillo CA, Marin-Neto JA, Avezum A, Sosa-Estani S, Rassi A Jr, Rosas F, Villena E, Quiroz R, Bonilla R, Britto C, Guhl F, Velazquez E, Bonilla L, Meeks B, Rao-Melacini P, Pogue J, Mattos A, Lazdins J, Rassi A, Connolly SJ, Yusuf S; BENEFIT Investigators. Randomized Trial of Benznidazole for Chronic Chagas' Cardiomyopathy. N Engl J Med. 2015 Oct;373(14):1295-306. doi: 10.1056/NEJMoa1507574. Epub 2015 Sep 1.

    PubMed 26323937

  • Marin-Neto JA, Rassi A Jr, Avezum A Jr, Mattos AC, Rassi A, Morillo CA, Sosa-Estani S, Yusuf S; BENEFIT Investigators. The BENEFIT trial: testing the hypothesis that trypanocidal therapy is beneficial for patients with chronic Chagas heart disease. Mem Inst Oswaldo Cruz. 2009 Jul;104 Suppl 1:319-24. doi: 10.1590/s0074-02762009000900042.

    PubMed 19753491

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Benznidazole in people with Chagas Disease and Trypanosomiasis, run by Population Health Research Institute at 47 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 47 sites in Brazil, Argentina, Colombia, Bolivia, El Salvador. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: through study completion, an average of 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00123916, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2020.

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