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news.Merck is planning to commence a Phase II investigational proof-of-concept clinical study to evaluate its oral antifungal agent Posaconazole for the treatment of chronic chagas disease.
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Chagas disease results from the infection with the protozoan parasite Trypanosoma cruzi that is spread by biting insects.
Merck has consulted with international agencies and research organizations to identify the current medical needs and reach consensus on a study design for posaconazole in asymptomatic chronic chagas disease.
Merck said that the proposed study is a randomised, placebo-controlled Phase II study of Posaconazole oral suspension (400mg twice daily) given for 60 days, either as monotherapy or concomitantly with benznidazole. Benznidazole monotherapy will serve as an active control.
Merck is now planning to recruit adult patients with chronic Chagas disease at several sites in South America and follow them for a total of 360 days. Results from the study are expected in 2012.
The study will utilise polymerase chain reaction (PCR) to evaluate the levels of Trypanosoma cruzi in blood samples as the primary endpoint for response to treatment.
Merck looks forward to working with interested partners to facilitate access if Posaconazole is shown to be beneficial in the treatment of chronic Chagas disease.