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    Clinical Trial Results:
    Proof of Concept Study of Eurartesim® in Patients with Imported Uncomplicated Plasmodium Vivax Malaria

    Summary
    EudraCT number
    		 2013-003763-56
    Trial protocol
    		 IT   ES   NL   DE  
    Global end of trial date
    23 Nov 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    11 Jul 2020
    First version publication date
    11 Jul 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    ST3073-ST3074-DM13-001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Alfasigma S.p.A.
    Sponsor organisation address
    Via Ragazzi del '99, Bologna, Italy,
    Public contact
    Giovanni Valentini - Medical Expert, Alfasigma S.p.A., 0039 0691393916,
    Scientific contact
    Giovanni Valentini - Medical Expert, Alfasigma S.p.A., 0039 0691393916,
    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
    21 Dec 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    02 Nov 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Nov 2016
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of an Eurartesim® treatment course in patients with imported uncomplicated P. vivax malaria. The efficacy will be primarily assessed as uncorrected Adequate Clinical and Parasitological Response (ACPR) at Day 21 of follow-up.
    Protection of trial subjects
    This study was conducted in accordance with the World Medical Association Declaration of Helsinki and ICH Topic E6, Guideline for Good Clinical Practice
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    18 Jun 2014
    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
    Spain: 2
    Country: Number of subjects enrolled
    Germany: 5
    Country: Number of subjects enrolled
    Italy: 18
    Country: Number of subjects enrolled
    Switzerland: 2
    Worldwide total number of subjects
    27
    EEA total number of subjects
    25
    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)
    1
    Adults (18-64 years)
    26
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 All patients were recruited from seven study centers of four countries: Italy (Rome, Brescia and Reggio Emilia), Germany (Munich and Berlin), Spain (Barcelona) and Switzerland (Bern)

    Pre-assignment
    Screening details
    		 Subjects screened for inclusion= 29; Subjects enrolled= 27

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    This was an open label study not requiring blinding conditions

    Arms
    Arm title
    		 Eurartesim® oral film coated tablet
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Eurartesim® (320/40mg PQP/DHA) film coated tablets
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Each patient received a specific amount of drug according to his/her body weight once a day for 3 consecutive days. In case the patient was hospitalized, appropriately trained personnel administered the study treatment. Outpatients were instructed to take Eurartesim® with a dose regimen of 1 administration every 24 hours over a period of 3 days, i.e. at Day 0 at the hospital under medical supervision, then after 24 hours (Day 1) and after 48 hours (Day 2) from the first administration. The daily dose of Eurartesim® was administered with water and without food (between meals) over 3 consecutive days for a total of 3 doses taken at the same time each day.

    Number of subjects in period 1
    		Eurartesim® oral film coated tablet
    Started
    27
    Completed
    20
    Not completed
    7
         Major violation due to age < 18
    1
         Lost to follow-up
    5
         Subj. left the hospital w/o medical authorization
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 The reporting group corresponds to the Intention to Treat (ITT) population that includes all patients taking at least one dose of the study drug.

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 27 27
    Age categorical
    Units: Subjects
        Adolescents (12-17 years)
    		 1 1
        Adults (18-64 years)
    		 26 26
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 35.26 ( 13.52 ) -
    Gender categorical
    Units: Subjects
        Female
    		 9 9
        Male
    		 18 18
    Subject analysis sets

    Subject analysis set title
    Per protocol (PP)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The Per Protocol (PP) population includes all patients who took the complete treatment and who did not meet any major protocol violations. The PP Population is the primary population for the efficacy analysis

    Subject analysis set title
    Per protocol (PP) baseline
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    In order to be able to complete the mandatory statistical analysis section also for a single arm clinical trial a “PP baseline subject analysis set” has been created.

    Subject analysis sets values
    		 Per protocol (PP) Per protocol (PP) baseline
    Number of subjects
    22
    22
    Age categorical
    Units: Subjects
        Adolescents (12-17 years)
    0
    0
        Adults (18-64 years)
    22
    22
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    36.77 ( 13.83 )
    36.77 ( 13.83 )
    Gender categorical
    Units: Subjects
        Female
    7
    7
        Male
    15
    15

    End points

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    End points reporting groups
    Reporting group title
    Eurartesim® oral film coated tablet
    Reporting group description
    		 -

    Subject analysis set title
    Per protocol (PP)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The Per Protocol (PP) population includes all patients who took the complete treatment and who did not meet any major protocol violations. The PP Population is the primary population for the efficacy analysis

    Subject analysis set title
    Per protocol (PP) baseline
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    In order to be able to complete the mandatory statistical analysis section also for a single arm clinical trial a “PP baseline subject analysis set” has been created.

    Primary: Proportion of Subjects with Uncorrected Adequate Clinical and Parasitological Response (ACPR) at Day 21

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    End point title
    		 Proportion of Subjects with Uncorrected Adequate Clinical and Parasitological Response (ACPR) at Day 21
    End point description
    End point type
    Primary
    End point timeframe
    Day 21
    End point values
    		 Per protocol (PP) Per protocol (PP) baseline
    Number of subjects analysed
    22
    22
    Units: Subjects
    18
    0
    Statistical analysis title
    		 Efficacy endpoints analysis
    Statistical analysis description
    The efficacy analysis was performed in the ITT and PP populations; however, given the nature of the study, the latter one was primary. The analysis for all the efficacy endpoints was descriptive. In addition, 95% Confidence Interval (CI) was computed with reference to the proportion of patients having Day 21 Uncorrected ACPR. The Confidence Interval for the primary end-point had a precision of 5%.
    Comparison groups
    Per protocol (PP) v Per protocol (PP) baseline
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    Method
    Parameter type
    		 Percentage
    Point estimate
    81.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 59.7
         upper limit
    		 94.8
    Notes
    [1] - In order to complete the mandatory statistical section for a single arm clinical trial the following data have been imputed: 1) the “PP baseline subject analysis set” is considered one group and the “PP subject analysis set” another group and, consequently, the n° of subjects in this analysis is 22 and not 44; 2) for the “PP baseline subject analysis set” the n° of subjects with uncorrected ACPR has been indicated as 0, as at baseline the n° of aparasitaemic subjects in the PP population was 0.

    Secondary: Proportion of Aparasitaemic Subjects at Day 1

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    End point title
    		 Proportion of Aparasitaemic Subjects at Day 1
    End point description
    End point type
    Secondary
    End point timeframe
    Day 1
    End point values
    		 Per protocol (PP)
    Number of subjects analysed
    22
    Units: Subjects
    9
    No statistical analyses for this end point

    Secondary: Proportion of Aparasitaemic Subjects at Day 2

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    End point title
    		 Proportion of Aparasitaemic Subjects at Day 2
    End point description
    End point type
    Secondary
    End point timeframe
    Day 2
    End point values
    		 Per protocol (PP)
    Number of subjects analysed
    22
    Units: Subjects
    20
    No statistical analyses for this end point

    Secondary: Proportion of Aparasitaemic Subjects at Day 7

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    End point title
    		 Proportion of Aparasitaemic Subjects at Day 7
    End point description
    End point type
    Secondary
    End point timeframe
    Day 7
    End point values
    		 Per protocol (PP)
    Number of subjects analysed
    22
    Units: Subjects
    21
    No statistical analyses for this end point

    Secondary: Proportion of Aparasitaemic Subjects at Day 21

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    End point title
    		 Proportion of Aparasitaemic Subjects at Day 21
    End point description
    End point type
    Secondary
    End point timeframe
    Day 21
    End point values
    		 Per protocol (PP)
    Number of subjects analysed
    22
    Units: Subjects
    18
    No statistical analyses for this end point

    Secondary: Proportion of Aparasitaemic Subjects at Day 42

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    End point title
    		 Proportion of Aparasitaemic Subjects at Day 42
    End point description
    End point type
    Secondary
    End point timeframe
    Day 42
    End point values
    		 Per protocol (PP)
    Number of subjects analysed
    22
    Units: Subjects
    16
    No statistical analyses for this end point

    Secondary: Proportion of Afebrile Subjects at Day 1

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    End point title
    		 Proportion of Afebrile Subjects at Day 1
    End point description
    End point type
    Secondary
    End point timeframe
    Day 1
    End point values
    		 Per protocol (PP)
    Number of subjects analysed
    22
    Units: Subjects
    18
    No statistical analyses for this end point

    Secondary: Proportion of Afebrile Subjects at Day 2

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    End point title
    		 Proportion of Afebrile Subjects at Day 2
    End point description
    End point type
    Secondary
    End point timeframe
    Day 2
    End point values
    		 Per protocol (PP)
    Number of subjects analysed
    22
    Units: Subjects
    22
    No statistical analyses for this end point

    Secondary: Proportion of Afebrile Subjects at Day 7

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    End point title
    		 Proportion of Afebrile Subjects at Day 7
    End point description
    End point type
    Secondary
    End point timeframe
    Day 7
    End point values
    		 Per protocol (PP)
    Number of subjects analysed
    22
    Units: Subjects
    21
    No statistical analyses for this end point

    Secondary: Proportion of Afebrile Subjects at Day 21

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    End point title
    		 Proportion of Afebrile Subjects at Day 21
    End point description
    End point type
    Secondary
    End point timeframe
    Day 21
    End point values
    		 Per protocol (PP)
    Number of subjects analysed
    22
    Units: Subjects
    18
    No statistical analyses for this end point

    Secondary: Proportion of Afebrile Subjects at Day 42

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    End point title
    		 Proportion of Afebrile Subjects at Day 42
    End point description
    End point type
    Secondary
    End point timeframe
    Day 42
    End point values
    		 Per protocol (PP)
    Number of subjects analysed
    22
    Units: Subjects
    16
    No statistical analyses for this end point

    Secondary: Proportion of Subjects with Uncorrected Adequate Clinical and Parasitological Response (ACPR) at Day 42

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    End point title
    		 Proportion of Subjects with Uncorrected Adequate Clinical and Parasitological Response (ACPR) at Day 42
    End point description
    End point type
    Secondary
    End point timeframe
    Day 42
    End point values
    		 Per protocol (PP)
    Number of subjects analysed
    22
    Units: Subjects
    16
    No statistical analyses for this end point

    Secondary: Proportion of Subjects with Treatment Failure (TF) at Day 21

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    End point title
    		 Proportion of Subjects with Treatment Failure (TF) at Day 21
    End point description
    End point type
    Secondary
    End point timeframe
    Day 21
    End point values
    		 Per protocol (PP)
    Number of subjects analysed
    22
    Units: Subjects
    1
    No statistical analyses for this end point

    Secondary: Proportion of Subjects with Treatment Failure (TF) at Day 42

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    End point title
    		 Proportion of Subjects with Treatment Failure (TF) at Day 42
    End point description
    End point type
    Secondary
    End point timeframe
    Day 42
    End point values
    		 Per protocol (PP)
    Number of subjects analysed
    22
    Units: Subjects
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Overall trial
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    ITT/Safety population
    Reporting group description
    		 The Intention to Treat (ITT) population includes all patients taking at least one dose of the study drug. This population is used for the safety analysis. As for the safety data presentation, it is referenced as Safety Population.

    Serious adverse events
    		 ITT/Safety population
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 27 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 ITT/Safety population
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    14 / 27 (51.85%)
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    2 / 27 (7.41%)
         occurrences all number
    2
    Hepatic enzyme increased
         subjects affected / exposed
    1 / 27 (3.70%)
         occurrences all number
    1
    Transaminases abnormal
         subjects affected / exposed
    1 / 27 (3.70%)
         occurrences all number
    1
    Transaminases increased
         subjects affected / exposed
    1 / 27 (3.70%)
         occurrences all number
    1
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 27 (3.70%)
         occurrences all number
    1
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    1 / 27 (3.70%)
         occurrences all number
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 27 (3.70%)
         occurrences all number
    1
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 27 (3.70%)
         occurrences all number
    1
    Diarrhoea
         subjects affected / exposed
    1 / 27 (3.70%)
         occurrences all number
    1
    Dyspepsia
         subjects affected / exposed
    1 / 27 (3.70%)
         occurrences all number
    1
    Vomiting
         subjects affected / exposed
    4 / 27 (14.81%)
         occurrences all number
    5
    Hepatobiliary disorders
    Hypertransaminasaemia
         subjects affected / exposed
    1 / 27 (3.70%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    2 / 27 (7.41%)
         occurrences all number
    2
    Skin and subcutaneous tissue disorders
    Rash maculo-papular
         subjects affected / exposed
    1 / 27 (3.70%)
         occurrences all number
    1
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    1 / 27 (3.70%)
         occurrences all number
    1
    Infections and infestations
    Gastroenteritis
         subjects affected / exposed
    1 / 27 (3.70%)
         occurrences all number
    1
    Nasopharyngitis
         subjects affected / exposed
    1 / 27 (3.70%)
         occurrences all number
    1
    Pneumonia
         subjects affected / exposed
    1 / 27 (3.70%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    23 Nov 2016
    A total of 100 male and female patients satisfying the inclusion criteria and presenting none of the exclusion criteria had to be enrolled in the study. However, the study was prematurely interrupted due to a very low rate of recruitment.
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    A total of 100 male and female patients satisfying the inclusion criteria and presenting none of the exclusion criteria had to be enrolled in the study. However, the study was prematurely interrupted due to a very low rate of recruitment.
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    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
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