drugset / Trial / NCT01489228

Proof-of-Concept Study of E1224 to Treat Adult Patients With Chagas Disease

NCT01489228 ↗

Phase 2 Unknown 230 enrolled Drugs for Neglected Diseases Eisai Inc. · collab
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study will assess the safety and efficacy of E1224, a pro-drug of ravuconazole, in individuals with chronic indeterminate Chagas disease recruited in research centres in Tarija and Cochabamba, Bolivia.

Timeline

Start
2011-06
Primary completion
2012-08
Completion
2013-12

Outcome

Missed primary endpoint

release “E1224 was found to be ineffective as a single-treatment agent (monotherapy)” dndi.org ↗

Drugs

EvaluationDrugModalityDoseRoute
Comparator Benznidazole Small molecule 5 mg/kg Oral
Subject E1224 Unknown 2000 mg Oral
Subject E1224 Unknown 2400 mg Oral
Subject E1224 Unknown 4000 mg Oral

Indications