Bayer reports Phase 3 trial of nifurtimox meets primary endpoint.
Bayer presented results from the CHICO part of the phase 3 clinical study of investigational nifurtimox in pediatric patients with Chagas disease at the "XV Taller sobre la enfermedad de Chagas" conference in Barcelona, Spain. The study met its primary endpoint, which was the serological response at one year after end of treatment, by demonstrating superiority of the 60-day nifurtimox treatment compared with historical placebo control. Safety and efficacy were evaluated throughout the clinical trial. CHICO was the first part of a prospective, randomized, double-blind, historically placebo controlled phase 3 trial to evaluate the efficacy, safety, and pharmacokinetics of nifurtimox in 330 pediatric patients with acute or chronic Chagas disease. The study was conducted at 25 investigational sites in Argentina, Bolivia and Colombia between 2016 and 2018.
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|Article Type:||Clinical report|
|Date:||Mar 14, 2019|
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