Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00123916
Status:
COMPLETED
Last Update Posted:
2020-03-03
First Post:
2005-07-21
Brief Title:
BENEFIT Evaluation of the Use of Antiparasital Drug Benznidazole in the Treatment of Chronic Chagas Disease
Sponsor:
Population Health Research Institute
Organization:
Population Health Research Institute
Study Overview
Official Title:
Benznidazole Evaluation for Interrupting Trypanosomiasis - The BENEFIT Trial
Status:
COMPLETED
Status Verified Date:
2020-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BENEFIT
Brief Summary:
Evaluate if benznidazole an antiparasite drug given at a dose calculated as 5mgkgday for 60 days now administered as a fixed daily dose of 300mg during 40 to 80 days of treatment - period adjusted according to the patients 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
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
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 5mgkgday for 60 days now administered as a fixed daily dose of 300mg during 40 to 80 days of treatment - period adjusted according to the patients 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 BoliviaBrazilColombia 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
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 5mgkgday for 60 days now administered as a fixed daily dose of 300mg during 40 to 80 days of treatment - period adjusted according to the patients 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 BoliviaBrazilColombia 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CONEP-11394 | OTHER | Comissão Nacional de Ética em Pesquisa CONEP | None |