drugset / Trial / NCT03378661

BENDITA BEnznidazole New Doses Improved Treatment and Associations

NCT03378661 ↗

Phase 2 Unknown 210 enrolled Drugs for Neglected Diseases
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Recent scientific advances have provided further impetus to develop new therapeutic approaches for Chagas Disease (CD) using different doses and duration of BZN, as well as combinations directed at multiple therapeutic targets to improve treatment response and tolerability and reduce the potential for development of resistance. This project focuses on the proof-of-concept evaluation of improved treatment regimens of BZN, with the assessment of new BZN-sparing regimens in monotherapy and in combination with E1224.

Timeline

Start
2016-11-30
Primary completion
2018-01-28
Completion
2018-07-27

Outcome

Met primary endpoint

paper Sustained parasitological clearance at 6 months was observed in 25 (89%) of 28 patients receiving benznidazole 300 mg daily for 8 weeks PMID 33836161 ↗

paper p<0·0001 for all group comparisons with placebo). PMID 33836161 ↗

paper Benznidazole induced effective antiparasitic response, regardless of treatment duration, dose, or combination with fosravuconazole, and was well tolerated PMID 33836161 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Benznidazole Small molecule 150 mg Oral
Subject Benznidazole Small molecule 300 mg Oral
Subject E1224 Unknown 100 mg Oral

Indications