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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Merck Sharp & Dohme Corp.

ClinicalTrials.gov Identifier:

NCT01377480

First received: May 13, 2011

Last updated: January 28, 2015

Last verified: January 2015

History of Changes

Tracking Information
First Received Date ^ICMJE	May 13, 2011
Last Updated Date	January 28, 2015
Start Date ^ICMJE	July 2011
Primary Completion Date	July 2014 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 20, 2011)	Number of participants with a reduction of parasitemia as measured by qualitative polymerase chain reaction (PCR) [ Time Frame: Day 180 ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01377480 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Study of the Use of Oral Posaconazole (POS) in the Treatment of Asymptomatic Chronic Chagas Disease (P05267)
Official Title ^ICMJE	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 (POS) to placebo for the treatment of asymptomatic Chagas disease.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Condition ^ICMJE	Chagas Disease
Intervention ^ICMJE	Drug: Posaconazole 10 mL orally twice daily for 60 days Other Name: SCH 056592 Drug: Placebo for posaconazole 10 mL orally twice daily for 60 days Drug: Benznidazole 200 mg orally twice daily for 60 days
Study Arm (s)	Experimental: Posaconazole Intervention: Drug: Posaconazole Placebo Comparator: Posaconazole Placebo Intervention: Drug: Placebo for posaconazole Experimental: Posaconazole + Benznidazole Interventions: Drug: Posaconazole Drug: Benznidazole Active Comparator: Posaconazole Placebo+ Benznidazole Interventions: Drug: Placebo for posaconazole Drug: Benznidazole
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	120
Completion Date	January 2015
Primary Completion Date	July 2014 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: - Must have a positive serology result for Trypanosoma cruzi on any 2 of 3 of the following tests: indirect immunofluorescence, indirect hemagglutination, or enzyme-linked immunoabsorbent assay (ELISA) Must have a positive qualitative polymerase chain reaction (PCR) for Trypanosoma cruzi Must have a normal 12-lead electrocardiogram (ECG) Must have a normal 2-D echocardiogram Must have no evidence of ventricular tachycardia on 24-hour Holter monitoring Female participants of childbearing age must be using a medically accepted method of birth control before beginning study drug treatment and must agree to continue its use during the study, or must have been surgically sterilized Female participants of childbearing potential must have a negative serum beta-human chorionic gonadotropin (hCG) pregnancy test at Screening and a negative urine pregnancy test at Baseline or within 72 hours before the start of study drug Exclusion Criteria: Are breastfeeding, pregnant, or planning to become pregnant Body weight <60 kg Have an immunodeficiency or are immunosuppressed History of megacolon with obstipation or megaesophagus with severe swallowing impairment. Have previously received treatment with benznidazole or nifurtimox Known allergy/sensitivity to azoles Has aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels greater than 2.5 times the upper limit of normal at Screening Has serum creatinine >2.5 mg/dL or 200 micromoles at Screening Has a history of severe alcohol abuse within two years from Screening Is taking any of the prohibited medication
Gender	Both
Ages	18 Years to 50 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ^ICMJE	Not Provided
Removed Location Countries	Argentina, Chile, Colombia, Germany, Guatemala, Mexico, Spain

Administrative Information
NCT Number ^ICMJE	NCT01377480
Other Study ID Numbers ^ICMJE	P05267
Has Data Monitoring Committee	Yes
Responsible Party	Merck Sharp & Dohme Corp.
Study Sponsor ^ICMJE	Merck Sharp & Dohme Corp.
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Merck Sharp & Dohme Corp.
Verification Date	January 2015
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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