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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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.

Detailed Summary:
Sponsor: Merck Sharp & Dohme Corp.

Current Primary Outcome: Percentage of Participants With a Successful Response as Measured by Qualitative Polymerase Chain Reaction [ Time Frame: Day 180 ]

Blood samples were collected for qualitative polymerase chain reaction (PCR) assay for Trypanosoma cruzi deoxyribonucleic acid (DNA). Successful response was defined as a negative qualitative PCR value at the Day 180 follow up visit.


Original Primary Outcome: Number of participants with a reduction of parasitemia as measured by qualitative polymerase chain reaction (PCR) [ Time Frame: Day 180 ]

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Merck Sharp & Dohme Corp.

Dates:
Date Received: May 13, 2011
Date Started: July 6, 2011
Date Completion:
Last Updated: April 17, 2017
Last Verified: April 2017