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

    Due to the EudraCT – Results system being out of service between 31 July 2015 and 12 January 2016, these results have been published in compliance with revised timelines.
    Summary
    EudraCT number
    		 2013-000161-36
    Trial protocol
    		 ES  
    Global end of trial date
    12 Jan 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    18 Feb 2016
    First version publication date
    18 Feb 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    MK-5592-055
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01377480
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Merck Protocol Code: P05267
    Sponsors
    Sponsor organisation name
    Merck Sharp & Dohme Corp.
    Sponsor organisation address
    2000 Galloping Hill Road, Kenilworth, NJ, United States, 07033
    Public contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp, +1 800-672-6372, ClinicalTrialsDisclosure@merck.com
    Scientific contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp, +1 800-672-6372, ClinicalTrialsDisclosure@merck.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    12 Jan 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    22 Jul 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Jan 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    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.
    Protection of trial subjects
    This study was conducted in conformance with Good Clinical Practice standards and applicable country and/or local statutes and regulations regarding ethical committee review, informed consent, and the protection of human subjects participating in biomedical research.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    06 Jul 2011
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Argentina: 93
    Country: Number of subjects enrolled
    Chile: 11
    Country: Number of subjects enrolled
    Colombia: 3
    Country: Number of subjects enrolled
    Guatemala: 2
    Country: Number of subjects enrolled
    Mexico: 1
    Country: Number of subjects enrolled
    Spain: 10
    Worldwide total number of subjects
    120
    EEA total number of subjects
    10
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    120
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 393 participants were screened, 123 were eligible for enrollment, and 120 were randomized.

    Period 1
    Period 1 title
    Treatment (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Subject, Monitor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Posaconazole
    Arm description
    		 Posaconazole (POS) 400 mg (10 mL) oral suspension twice daily for 60 days
    Arm type
    		 Experimental

    Investigational medicinal product name
    Posaconazole
    Investigational medicinal product code
    Other name
    MK-5592
    Pharmaceutical forms
    Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    400 mg (10 mL) oral suspension twice daily for 60 days

    Arm title
    		 Placebo
    Arm description
    		 POS placebo (10 mL) oral suspension twice daily for 60 days
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo to posaconazole
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    POS placebo (10 mL) oral suspension twice daily for 60 days

    Arm title
    		 Posaconazole + Benznidazole
    Arm description
    		 POS 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
    Arm type
    		 Experimental

    Investigational medicinal product name
    Posaconazole
    Investigational medicinal product code
    Other name
    MK-5592
    Pharmaceutical forms
    Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    400 mg (10 mL) oral suspension twice daily for 60 days

    Investigational medicinal product name
    Benznidazole
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    BNZ 100 mg oral tablet twice daily (200-mg daily dose) for 60 days

    Arm title
    		 Benznidazole + Placebo
    Arm description
    		 BNZ 100 mg oral tablet twice daily (200-mg daily dose) for 60 days and POS placebo (10 mL) oral suspension twice daily for 60 days
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Placebo to posaconazole
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    POS placebo (10 mL) oral suspension twice daily for 60 days

    Investigational medicinal product name
    Benznidazole
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    BNZ 100 mg oral tablet twice daily (200-mg daily dose) for 60 days

    Number of subjects in period 1
    		Posaconazole Placebo Posaconazole + Benznidazole Benznidazole + Placebo
    Started
    32
    30
    28
    30
    Completed
    32
    29
    18
    19
    Not completed
    0
    1
    10
    11
         Consent withdrawn by subject
    -
    -
    1
    -
         Evidence of drug-induced hepatotoxicity
    -
    1
    1
    -
         Not specified
    -
    -
    7
    6
         Serious adverse event
    -
    -
    1
    1
         Protocol deviation
    -
    -
    -
    4

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Posaconazole
    Reporting group description
    		 Posaconazole (POS) 400 mg (10 mL) oral suspension twice daily for 60 days

    Reporting group title
    Placebo
    Reporting group description
    		 POS placebo (10 mL) oral suspension twice daily for 60 days

    Reporting group title
    Posaconazole + Benznidazole
    Reporting group description
    		 POS 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

    Reporting group title
    Benznidazole + Placebo
    Reporting group description
    		 BNZ 100 mg oral tablet twice daily (200-mg daily dose) for 60 days and POS placebo (10 mL) oral suspension twice daily for 60 days

    Reporting group values
    		 Posaconazole Placebo Posaconazole + Benznidazole Benznidazole + Placebo Total
    Number of subjects
    		 32 30 28 30 120
    Age Categorical
    Units: Subjects
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 40.3 ( 8.6 ) 42.2 ( 7.8 ) 40.2 ( 8.4 ) 40.4 ( 7.7 ) -
    Gender Categorical
    Units: Subjects
        Female
    		 16 7 13 17 53
        Male
    		 16 23 15 13 67

    End points

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    End points reporting groups
    Reporting group title
    Posaconazole
    Reporting group description
    		 Posaconazole (POS) 400 mg (10 mL) oral suspension twice daily for 60 days

    Reporting group title
    Placebo
    Reporting group description
    		 POS placebo (10 mL) oral suspension twice daily for 60 days

    Reporting group title
    Posaconazole + Benznidazole
    Reporting group description
    		 POS 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

    Reporting group title
    Benznidazole + Placebo
    Reporting group description
    		 BNZ 100 mg oral tablet twice daily (200-mg daily dose) for 60 days and POS placebo (10 mL) oral suspension twice daily for 60 days

    Primary: Percentage of Participants with a Successful Response as Measured by Qualitative Polymerase Chain Reaction

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    End point title
    		 Percentage of Participants with a Successful Response as Measured by Qualitative Polymerase Chain Reaction
    End point description
    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. The Full Analysis Population included all randomized participants who received at least one dose of study drug.
    End point type
    Primary
    End point timeframe
    Day 180
    End point values
    		 Posaconazole Placebo Posaconazole + Benznidazole Benznidazole + Placebo
    Number of subjects analysed
    32
    30
    28
    30
    Units: Percentage of participants
        number (confidence interval 95%)
    15.6 (6.9 to 31.8)
    10 (3.5 to 25.6)
    82.1 (64.4 to 92.1)
    86.7 (70.3 to 94.7)
    Statistical analysis title
    		 Difference in Successful Response
    Comparison groups
    Placebo v Posaconazole
    Number of subjects included in analysis
    62
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5125261
    Method
    		 Miettinen & Nurminen
    Parameter type
    		 Risk difference (RD)
    Point estimate
    5.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -12.6
         upper limit
    		 23.7

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All adverse events: up to Day 90 (30 days post treatment); procedure-related serious adverse events: up to Day 360 (300 days post treatment)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    14.0
    Reporting groups
    Reporting group title
    Posaconazole
    Reporting group description
    		 Posaconazole (POS) 400 mg (10 mL) oral suspension twice daily for 60 days

    Reporting group title
    Posaconazole + Benznidazole
    Reporting group description
    		 POS 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

    Reporting group title
    Benznidazole + Placebo
    Reporting group description
    		 BNZ 100 mg oral tablet twice daily (200-mg daily dose) for 60 days and POS placebo (10 mL) oral suspension twice daily for 60 days

    Reporting group title
    Placebo
    Reporting group description
    		 POS placebo (10 mL) oral suspension twice daily for 60 days Placebo

    Serious adverse events
    		 Posaconazole Posaconazole + Benznidazole Benznidazole + Placebo Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 32 (3.13%)
    2 / 28 (7.14%)
    3 / 30 (10.00%)
    1 / 30 (3.33%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Head injury
         subjects affected / exposed
    0 / 32 (0.00%)
    0 / 28 (0.00%)
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Neuropathy peripheral
         subjects affected / exposed
    0 / 32 (0.00%)
    0 / 28 (0.00%)
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous
         subjects affected / exposed
    0 / 32 (0.00%)
    0 / 28 (0.00%)
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 32 (3.13%)
    0 / 28 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Hepatitis
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 28 (3.57%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Photodermatosis
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 28 (3.57%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rash
         subjects affected / exposed
    0 / 32 (0.00%)
    0 / 28 (0.00%)
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Posaconazole Posaconazole + Benznidazole Benznidazole + Placebo Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    12 / 32 (37.50%)
    18 / 28 (64.29%)
    21 / 30 (70.00%)
    8 / 30 (26.67%)
    Investigations
    Transaminases increased
         subjects affected / exposed
    1 / 32 (3.13%)
    2 / 28 (7.14%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
         occurrences all number
    1
    2
    0
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 32 (0.00%)
    3 / 28 (10.71%)
    2 / 30 (6.67%)
    2 / 30 (6.67%)
         occurrences all number
    0
    3
    2
    2
    Headache
         subjects affected / exposed
    3 / 32 (9.38%)
    8 / 28 (28.57%)
    4 / 30 (13.33%)
    2 / 30 (6.67%)
         occurrences all number
    4
    14
    5
    3
    Paraesthesia
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 28 (3.57%)
    2 / 30 (6.67%)
    0 / 30 (0.00%)
         occurrences all number
    0
    1
    2
    0
    Somnolence
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 28 (3.57%)
    2 / 30 (6.67%)
    0 / 30 (0.00%)
         occurrences all number
    0
    1
    2
    0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    2 / 32 (6.25%)
    1 / 28 (3.57%)
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences all number
    2
    1
    1
    0
    Pyrexia
         subjects affected / exposed
    0 / 32 (0.00%)
    0 / 28 (0.00%)
    2 / 30 (6.67%)
    0 / 30 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 28 (3.57%)
    3 / 30 (10.00%)
    0 / 30 (0.00%)
         occurrences all number
    0
    1
    3
    0
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    0 / 32 (0.00%)
    3 / 28 (10.71%)
    2 / 30 (6.67%)
    1 / 30 (3.33%)
         occurrences all number
    0
    3
    2
    1
    Diarrhoea
         subjects affected / exposed
    0 / 32 (0.00%)
    0 / 28 (0.00%)
    0 / 30 (0.00%)
    2 / 30 (6.67%)
         occurrences all number
    0
    0
    0
    2
    Gastritis
         subjects affected / exposed
    3 / 32 (9.38%)
    0 / 28 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
         occurrences all number
    3
    0
    0
    0
    Nausea
         subjects affected / exposed
    3 / 32 (9.38%)
    5 / 28 (17.86%)
    3 / 30 (10.00%)
    1 / 30 (3.33%)
         occurrences all number
    3
    7
    4
    1
    Vomiting
         subjects affected / exposed
    1 / 32 (3.13%)
    2 / 28 (7.14%)
    2 / 30 (6.67%)
    0 / 30 (0.00%)
         occurrences all number
    1
    3
    3
    0
    Skin and subcutaneous tissue disorders
    Erythema
         subjects affected / exposed
    0 / 32 (0.00%)
    2 / 28 (7.14%)
    2 / 30 (6.67%)
    0 / 30 (0.00%)
         occurrences all number
    0
    2
    2
    0
    Pruritus
         subjects affected / exposed
    0 / 32 (0.00%)
    3 / 28 (10.71%)
    4 / 30 (13.33%)
    0 / 30 (0.00%)
         occurrences all number
    0
    3
    4
    0
    Rash
         subjects affected / exposed
    1 / 32 (3.13%)
    4 / 28 (14.29%)
    6 / 30 (20.00%)
    0 / 30 (0.00%)
         occurrences all number
    1
    5
    8
    0
    Rash pruritic
         subjects affected / exposed
    0 / 32 (0.00%)
    0 / 28 (0.00%)
    2 / 30 (6.67%)
    0 / 30 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Urticaria
         subjects affected / exposed
    0 / 32 (0.00%)
    0 / 28 (0.00%)
    3 / 30 (10.00%)
    0 / 30 (0.00%)
         occurrences all number
    0
    0
    3
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 32 (0.00%)
    2 / 28 (7.14%)
    1 / 30 (3.33%)
    0 / 30 (0.00%)
         occurrences all number
    0
    2
    1
    0
    Back pain
         subjects affected / exposed
    0 / 32 (0.00%)
    0 / 28 (0.00%)
    0 / 30 (0.00%)
    2 / 30 (6.67%)
         occurrences all number
    0
    0
    0
    2
    Pain in extremity
         subjects affected / exposed
    0 / 32 (0.00%)
    2 / 28 (7.14%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
         occurrences all number
    0
    3
    0
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    2 / 32 (6.25%)
    3 / 28 (10.71%)
    0 / 30 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    2
    3
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    02 May 2011
    Changes in Amendment 1: Number of centers was changed from 8 to 10; text in the Inclusion/Exclusion criteria was changed to specify that 12-lead electrocardiogram and 2-D echocardiogram results, if not normal, must be determined to be clinically significant.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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