NCT04897516

Shorter Benznidazole Regimens Compared to the Standard Regimen for Chagas Disease

Phase III Randomized,Multicenter 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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Laboratorio Elea Phoenix S.A. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chagas Disease

Interventions

Type	Name	Description
DRUG	Short regimen of benznidazole	Benznidazole, under the brand name Abarax (100 mg tablet), 300 mg divided into three daily doses (100 mg every 08 hours) for 2 weeks.
DRUG	Short treatment with benznidazole	Benznidazole, under the brand name Abarax (100 mg tablet), 300 mg divided into three daily doses (100 mg every 08 hours) for 4 weeks.
DRUG	Standard treatment with benznidazole	Benznidazole, 300 mg divided into three daily doses (100 mg every 08 hours), orally for 8 weeks

Timeline

• Start date: 2021-07-28
• Primary completion: 2026-06-01
• Completion: 2026-12-01
• First posted: 2021-05-21
• Last updated: 2023-11-30

Locations

6 sites across 1 country: Argentina