Ignite Creation Date:
2024-05-06 @ 4:10 PM
Last Modification Date:
2024-10-26 @ 2:05 PM
Study NCT ID:
NCT04897516
Status:
RECRUITING
Last Update Posted:
2023-11-30
First Post:
2021-05-18
Brief Title:
Shorter Benznidazole Regimens Compared to the Standard Regimen for Chagas Disease
Sponsor:
Laboratorio Elea Phoenix SA
Organization:
Laboratorio Elea Phoenix SA
Study Overview
Official Title:
Phase III RandomizedMulticenter Non-inferiority Study to Evaluate the Efficacy and Safety of Shorter Benznidazole Regimens Compared to the Standard Regimen to Treat Adult Patients With Chronic Chagas Disease
Status:
RECRUITING
Status Verified Date:
2023-09
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:
NuestroBen
Brief Summary:
Chagas disease a parasitic infection caused by Trypanosoma cruzi is endemic in much of Latin America and affects people throughout the world Currently treatment with the only two drugs effective against the infection benznidazole and nifurtimox has significant limitations including frequent adverse effects in adult patients However timely treatment is key to achieving global objectives of controlling the disease The standard treatment has a long duration 60 days NuestroBen will test the hypothesis that shorter treatment regimens of 14 days and 28 days will be non-inferior to the standard 60-day treatment while improving the safety profile
Detailed Description:
Chagas disease is a vector-borne parasitic infection affecting an estimated 6 million people worldwide Very few people have been able to access antiparasitic treatment for the disease and about 20 of those who do initiate treatment are unable to complete it due to the long duration 2 months and side effects associated with the current regimen Benznidazole is one of only two drugs with proven efficacy against Trypanosoma cruzi the parasite that causes the disease An earlier Phase 2 clinical trial BENDITA indicated 89 of 30 patients treated with a shorter 2-week regimen of benznidazole maintained sustained parasite clearance after 12 months of follow-up with no discontinuations of treatment due to side effects The current study will evaluate shorter treatment regimens with benznidazole in a Phase III clinical trial NuestroBen will assess the efficacy and safety of 2-week and 4-week regimens of BZN 300 mg daily compared to the standard treatment of BZN 300 mg daily for 8 weeks in terms of reducing and eliminating the T cruzi parasite in adults in the chronic phase of Chagas disease with the indeterminate form or mild cardiac progression Efficacy will be measured through conversion from positive to negative parasitaemia according to the results of qualitative PCR tests from the end of treatment and up to 12 months of follow-up from the end of treatment Safety will be compared according to the frequency and severity of adverse events Patients adherence to treatment in each study arm will also be described
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None