NCT01377480

A Study of the Use of Oral Posaconazole (POS) in the Treatment of Asymptomatic Chronic Chagas Disease (P05267)

Phase 2 Proof-of-Activity Study of Oral Posaconazole in the Treatment of Asymptomatic Chronic Chagas Disease (Phase 2, Protocol No. P05267)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

This is a study to compare the efficacy of oral posaconazole to placebo for the treatment of asymptomatic Chagas disease. The primary hypothesis of the study is that posaconazole 400 mg twice daily improves therapeutic response compared to placebo in participants with a diagnosis of asymptomatic chronic Chagas disease.

Conditions

• Chagas Disease

Interventions

Type	Name	Description
DRUG	Posaconazole	POS 40 mg/mL oral suspension
DRUG	Placebo for posaconazole	Placebo oral suspension
DRUG	Benznidazole	BNZ 100 mg oral tablet

Timeline

• Start date: 2011-07-06
• Primary completion: 2014-07-22
• Completion: 2015-01-12
• First posted: 2011-06-21
• Last updated: 2018-08-27
• Results posted: 2015-08-10