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: April 17, 2017

Last verified: April 2017

History of Changes

Tracking Information

First Received Date ^ICMJE

May 13, 2011

Last Updated Date

April 17, 2017

Actual Start Date ^ICMJE

July 6, 2011

Primary Completion Date

July 22, 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 Measures ^ICMJE

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

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 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 Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
Primary Purpose: Treatment

Condition ^ICMJE

Chagas Disease

Intervention ^ICMJE

Drug: Posaconazole
POS 40 mg/mL oral suspension

Other Name: SCH 056592, MK-5592
Drug: Placebo for posaconazole
Placebo oral suspension
Drug: Benznidazole
BNZ 100 mg oral tablet

Study Arms

Experimental: Posaconazole
Posaconazole (POS) 400 mg (10 mL) oral suspension twice daily for 60 days

Intervention: Drug: Posaconazole
Placebo Comparator: Placebo
Posaconazole placebo (10 mL) oral suspension twice daily for 60 days

Intervention: Drug: Placebo for posaconazole
Experimental: Posaconazole + Benznidazole
Posaconazole 400 mg (10 mL) oral suspension twice daily for 60 days and benznidazole (BNZ) 100 mg oral tablet twice daily (200-mg daily dose) for 60 days
Interventions:
- Drug: Posaconazole
- Drug: Benznidazole
Active Comparator: Benznidazole + Placebo
Posaconazole placebo (10 mL) oral suspension twice daily for 60 days and benznidazole 100 mg oral tablet twice daily (200-mg daily dose) for 60 days
Interventions:
- Drug: Placebo for posaconazole
- Drug: Benznidazole

Publications *

Morillo CA, Waskin H, Sosa-Estani S, Del Carmen Bangher M, Cuneo C, Milesi R, Mallagray M, Apt W, Beloscar J, Gascon J, Molina I, Echeverria LE, Colombo H, Perez-Molina JA, Wyss F, Meeks B, Bonilla LR, Gao P, Wei B, McCarthy M, Yusuf S; STOP-CHAGAS Investigators. Benznidazole and Posaconazole in Eliminating Parasites in Asymptomatic T. Cruzi Carriers: The STOP-CHAGAS Trial. J Am Coll Cardiol. 2017 Feb 28;69(8):939-947. doi: 10.1016/j.jacc.2016.12.023.

* 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 12, 2015

Primary Completion Date

July 22, 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

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years to 50 Years (Adult)

Accepts Healthy Volunteers

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
MK-5592-055 ( Other Identifier: Merck Protocol Number )

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Plan to Share IPD:

Yes

Plan Description:

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php

Responsible Party

Merck Sharp & Dohme Corp.

Study Sponsor ^ICMJE

Merck Sharp & Dohme Corp.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Medical Director

Merck Sharp & Dohme Corp.

PRS Account

Merck Sharp & Dohme Corp.

Verification Date

April 2017

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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