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    Clinical Trial Results:
    An Open-Label, Dose-Ranging Study of Prasugrel in Pediatric Patients with Sickle Cell Disease

    Summary
    EudraCT number
    		 2017-001243-12
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    02 Nov 2012

    Results information
    Results version number
    		 v1(current)
    This version publication date
    08 Jun 2017
    First version publication date
    08 Jun 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    H7T-MC-TACX
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01476696
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Trial ID: 12324
    Sponsors
    Sponsor organisation name
    Eli Lilly and Company
    Sponsor organisation address
    Lilly Corporate Center, Indianapolis, IN, United States, 46285
    Public contact
    Available Mon ‐ Fri 9 AM ‐ 5 PM EST, Eli Lilly and Company, 1 877‐CTLilly,
    Scientific contact
    Available Mon ‐ Fri 9 AM ‐ 5 PM EST, Eli Lilly and Company, 1 877‐285‐4559,
    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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    02 Nov 2012
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Nov 2012
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study is to determine the correct prasugrel dosage to be given to children with sickle cell disease (SCD).
    Protection of trial subjects
    This study was conducted in accordance with International Conference on Harmonization (ICH) Good Clinical Practice, and the principles of the Declaration of Helsinki, in addition to following the laws and regulations of the country or countries in which a study is conducted.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    30 Nov 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
    United States: 33
    Worldwide total number of subjects
    33
    EEA total number of subjects
    0
    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)
    21
    Adolescents (12-17 years)
    12
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 The study was conducted in 2 parts: Part A (single-dose range finding phase) then Part B (once-daily repeated dosing phase). Participants completing Part A could, but were not required to, participate in Part B. There were 2 dosing periods during Part B of the study.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Part A: Prasugrel Single Dose
    Arm description
    		 Participants who only enrolled in Part A of the study. Part A: 0.03 milligrams per kilogram (mg/kg) up to 0.60 mg/kg Prasugrel, each dose titrated up or down for each participant in order to achieve desired platelet inhibition (20% to 50%). Single dose administered orally [oral-disintegrating tablet (ODT)] up to 3 times, at different mg/kg doses, with up to 18 days between doses.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Prasugrel Single Dose (Part A)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Prasugrel 0.03 milligrams per kilogram (mg/kg) to 0.60 mg/kg dosage to be titrated up or down based on desired platelet inhibition, administered orally [oral-disintegrating tablet (ODT)], single dose given up to 3 occasions, at different strengths, with up to 18 days between doses.

    Arm title
    		 Part B: Prasugrel Once-Daily Dose
    Arm description
    		 Participants who only enrolled in Part B of the study. Part B: Daily Prasugrel dose (mg/kg) expected to achieve mean platelet activation inhibition of 30%, administered orally, ODT, once daily for 14 ± 4 days (first dosing period during Part B). Initial dose, 0.08 mg/kg Prasugrel, administered then pharmacodynamic (PD) response measured 4 hours later. Based on 4-hour PD response, each participant assigned to either 0.08 or 0.06 mg/kg Prasugrel, administered orally, once daily for the remainder of the first dosing period in Part B. For the second continuous 14 ± 4-day period, participants were administered 1 of 3 possible doses: 0.06, 0.08, or 0.12 mg/kg depending on their steady-state PD response at the end of the first dosing period, such that the second dose would be unlikely to exceed 50% platelet inhibition. Participants received study drug for a total of 28 ± 8 days during Part B of the study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Prasugrel Once-Daily Dose (Part B)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Daily prasugrel dose (mg/kg) that is expected to achieve mean platelet activation inhibition of 30% administered orally, once daily for 10-18 days and then followed by prasugrel dose (mg/kg) that is expected to achieve mean platelet activation inhibition of 50% administered orally, once daily for 10-18 days, for a total of 20-36 days.

    Arm title
    		 Part A then Part B: Prasugrel Single Dose Then Once-Daily Dose
    Arm description
    		 Participants who enrolled in Part A and B of study. Part A: 0.03 up to 0.60 mg/kg Prasugrel, each dose titrated up or down for each participant to achieve desired platelet inhibition (20% to 50%). Single dose administered orally, ODT, up to 3 times, at different mg/kg doses, with up to 18 days between doses. Part B: Daily Prasugrel dose (mg/kg) expected to achieve mean platelet activation inhibition of 30%, administered orally, ODT, once daily for 14 ± 4 days (first dosing period in Part B). Initial dose, 0.08 mg/kg Prasugrel, administered then PD response measured 4 hours later. Based on 4-hour PD response, each participant assigned to 0.08 or 0.06 mg/kg Prasugrel once daily for remainder of first dosing period. For second 14 ± 4-day period, participants assigned to 1 of 3 possible doses: 0.06, 0.08, or 0.12 mg/kg depending on steady-state PD response at end of first dosing period, such that the second dose would be unlikely to exceed 50% platelet inhibition.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Prasugrel Single Dose (Part A)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Prasugrel 0.03 milligrams per kilogram (mg/kg) to 0.60 mg/kg dosage to be titrated up or down based on desired platelet inhibition, administered orally [oral-disintegrating tablet (ODT)], single dose given up to 3 occasions, at different strengths, with up to 18 days between doses.

    Investigational medicinal product name
    Prasugrel Once-Daily Dose (Part B)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Daily prasugrel dose (mg/kg) that is expected to achieve mean platelet activation inhibition of 30% administered orally, once daily for 10-18 days and then followed by prasugrel dose (mg/kg) that is expected to achieve mean platelet activation inhibition of 50% administered orally, once daily for 10-18 days, for a total of 20-36 days.

    Number of subjects in period 1
    		Part A: Prasugrel Single Dose Part B: Prasugrel Once-Daily Dose Part A then Part B: Prasugrel Single Dose Then Once-Daily Dose
    Started
    15
    9
    9
    Received at least 1 dose of study drug
    15
    9
    9
    Completed
    12
    8
    9
    Not completed
    3
    1
    0
         Consent withdrawn by subject
    1
    -
    -
         Sponsor decision
    2
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall Study
    Reporting group description
    		 -

    Reporting group values
    		 Overall Study Total
    Number of subjects
    		 33 33
    Age, Customized
    Units: participants
        ≥2 and ≤5 years
    		 7 7
        ≥6 and ≤11 years
    		 14 14
        ≥12 and ≤17 years
    		 12 12
    Gender, Male/Female
    Units: Participants
        Female
    		 19 19
        Male
    		 14 14
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 1 1
        Not Hispanic or Latino
    		 32 32
        Unknown or Not Reported
    		 0 0
    Race/Ethnicity, Customized
    Units: Subjects
        Native Hawaiian or Other Pacific Islander
    		 1 1
        Black or African American
    		 32 32
    Region of Enrollment
    Units: Subjects
        United States
    		 33 33
    Genotype
    The number of participants who have the homozygous sickle cell (HbSS) or hemoglobin S beta^0 thalassemia (HbS β^0 thalassemia)] sickle cell genotype.
    Units: Subjects
        HbSS
    		 30 30
        HbS Beta^0 Thalassemia
    		 3 3
    Height
    Units: centimeters (cm)
        arithmetic mean (standard deviation)
    		 139.21 ( 22.663 ) -
    Weight
    Units: kilograms (kg)
        arithmetic mean (standard deviation)
    		 38.55 ( 18.785 ) -
    Body Mass Index
    Body mass index is an estimate of body fat based on body weight divided by height squared.
    Units: kilograms per square meter (kg/m^2)
        arithmetic mean (standard deviation)
    		 18.64 ( 4.091 ) -

    End points

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    End points reporting groups
    Reporting group title
    Part A: Prasugrel Single Dose
    Reporting group description
    		 Participants who only enrolled in Part A of the study. Part A: 0.03 milligrams per kilogram (mg/kg) up to 0.60 mg/kg Prasugrel, each dose titrated up or down for each participant in order to achieve desired platelet inhibition (20% to 50%). Single dose administered orally [oral-disintegrating tablet (ODT)] up to 3 times, at different mg/kg doses, with up to 18 days between doses.

    Reporting group title
    Part B: Prasugrel Once-Daily Dose
    Reporting group description
    		 Participants who only enrolled in Part B of the study. Part B: Daily Prasugrel dose (mg/kg) expected to achieve mean platelet activation inhibition of 30%, administered orally, ODT, once daily for 14 ± 4 days (first dosing period during Part B). Initial dose, 0.08 mg/kg Prasugrel, administered then pharmacodynamic (PD) response measured 4 hours later. Based on 4-hour PD response, each participant assigned to either 0.08 or 0.06 mg/kg Prasugrel, administered orally, once daily for the remainder of the first dosing period in Part B. For the second continuous 14 ± 4-day period, participants were administered 1 of 3 possible doses: 0.06, 0.08, or 0.12 mg/kg depending on their steady-state PD response at the end of the first dosing period, such that the second dose would be unlikely to exceed 50% platelet inhibition. Participants received study drug for a total of 28 ± 8 days during Part B of the study.

    Reporting group title
    Part A then Part B: Prasugrel Single Dose Then Once-Daily Dose
    Reporting group description
    		 Participants who enrolled in Part A and B of study. Part A: 0.03 up to 0.60 mg/kg Prasugrel, each dose titrated up or down for each participant to achieve desired platelet inhibition (20% to 50%). Single dose administered orally, ODT, up to 3 times, at different mg/kg doses, with up to 18 days between doses. Part B: Daily Prasugrel dose (mg/kg) expected to achieve mean platelet activation inhibition of 30%, administered orally, ODT, once daily for 14 ± 4 days (first dosing period in Part B). Initial dose, 0.08 mg/kg Prasugrel, administered then PD response measured 4 hours later. Based on 4-hour PD response, each participant assigned to 0.08 or 0.06 mg/kg Prasugrel once daily for remainder of first dosing period. For second 14 ± 4-day period, participants assigned to 1 of 3 possible doses: 0.06, 0.08, or 0.12 mg/kg depending on steady-state PD response at end of first dosing period, such that the second dose would be unlikely to exceed 50% platelet inhibition.

    Subject analysis set title
    Entire Study Population
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants enrolled in Part A, Part A and B, or only Part B of study. Part A: 0.03 up to 0.60 mg/kg Prasugrel, each dose titrated up or down for each participant to achieve desired platelet inhibition (20% to 50%). Single dose administered orally, ODT, up to 3 times, at different mg/kg doses, with up to 18 days between doses. Part B: Daily Prasugrel dose (mg/kg) expected to achieve mean platelet activation inhibition of 30%, administered orally, ODT, once daily for 14 ± 4 days (first dosing period in Part B). Initial dose, 0.08 mg/kg Prasugrel, administered then PD response measured 4 hours later. Based on 4-hour PD response, each participant assigned to 0.08 or 0.06 mg/kg Prasugrel once daily for remainder of first dosing period. For second 14 ± 4-day period, participants assigned to 1 of 3 possible doses: 0.06, 0.08, or 0.12 mg/kg depending on steady-state PD response at end of first dosing period, so that the second dose would be unlikely to exceed 50% platelet inhibition.

    Subject analysis set title
    Part B: Baseline
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants in Part B of the study, prior to receiving treatment (Prasugrel once-daily doses).

    Subject analysis set title
    Part B: Prasugrel Once-Daily Dose (0.06 mg/kg)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants who received 0.06 mg/kg Prasugrel administered orally, ODT, once daily, anytime (first or second dosing period) during Part B of the study, for a total of up to 36 days.

    Subject analysis set title
    Part B: Prasugrel Once-Daily Dose (0.08 mg/kg)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants who received 0.08 mg/kg Prasugrel administered orally, ODT, once daily, anytime (first or second dosing period) during Part B of the study, for a total of up to 36 days.

    Subject analysis set title
    Part B: Prasugrel Once-Daily Dose (0.12 mg/kg)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants who received 0.12 mg/kg Prasugrel administered orally, ODT, once daily, anytime (first or second dosing period) during Part B of the study, for a total of up to 36 days.

    Primary: Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) of Prasugrel active metabolite (Pras-AM)

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    End point title
    		 Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) of Prasugrel active metabolite (Pras-AM) [1]
    End point description
    AUC of Pras-AM from time 0 up to the last sampling time of 4 hours postdose [AUC(0-tlast)] is reported by dose administered [0.03, 0.05, 0.07, 0.09, 0.11, 0.13, 0.15, 0.2, 0.25, 0.3, 0.35, 0.4, 0.45, 0.5, 0.55, and 0.6 milligrams per kilogram (mg/kg)] during Part A (single-dose range finding phase) and is reported for doses administered on site (0.06, 0.08, and 0.12 mg/kg) during Part B (once-daily repeated dosing phase) of the study. Four participants received the same dose at multiple visits where pharmacokinetic samples were collected. 99999 = NA: The geometric coefficient of variation could not be determined because data for only 1 profile were analyzed.
    End point type
    Primary
    End point timeframe
    Parts A and B: 0.5, 1, 1.5, 2, 4 hours postdose
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Data for Primary Outcome Measures 2 were collected for presentation of results in a scatter plot and were not intended to be summarized due to the limited number of participants per treatment.
    End point values
    		 Entire Study Population
    Number of subjects analysed
    33 [2]
    Units: nanograms*hour per milliliter (ng*hr/mL)
    geometric mean (geometric coefficient of variation)
        Part A: 0.03 mg/kg (n=2)
    8.68 ( 36 )
        Part A: 0.05 mg/kg (n=2)
    14.5 ( 44 )
        Part A: 0.07 mg/kg (n=2)
    20.8 ( 31 )
        Part A: 0.09 mg/kg (n=2)
    31.3 ( 25 )
        Part A: 0.11 mg/kg (n=1)
    22.2 ( 99999 )
        Part A: 0.13 mg/kg (n=2)
    50.3 ( 20 )
        Part A: 0.15 mg/kg (n=2)
    35.2 ( 86 )
        Part A: 0.2 mg/kg (n=2)
    43.7 ( 48 )
        Part A: 0.25 mg/kg (n=3)
    60.7 ( 88 )
        Part A: 0.3 mg/kg (n=6)
    87.9 ( 52 )
        Part A: 0.35 mg/kg (n=11)
    111 ( 59 )
        Part A: 0.4 mg/kg (n=14)
    108 ( 55 )
        Part A: 0.45 mg/kg (n=8)
    136 ( 53 )
        Part A: 0.5 mg/kg (n=7)
    186 ( 36 )
        Part A: 0.55 mg/kg (n=1)
    87 ( 99999 )
        Part A: 0.6 mg/kg (n=3)
    299 ( 4 )
        Part B: 0.06 mg/kg (n=7)
    16.3 ( 50 )
        Part B: 0.08 mg/kg (n=17)
    27.1 ( 20 )
        Part B: 0.12 mg/kg (n=8)
    38.5 ( 15 )
    Notes
    [2] - 99999=NA
    No statistical analyses for this end point

    Primary: Percentage of Platelet Inhibition as Measured by VerifyNow™P2Y12 (VN)

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    End point title
    		 Percentage of Platelet Inhibition as Measured by VerifyNow™P2Y12 (VN) [3]
    End point description
    Accumetrics VN assay: A point-of-care device that measures platelet aggregation. Percentage of platelet inhibition is reported by dose administered [0.03, 0.05, 0.07, 0.09, 0.11, 0.13, 0.15, 0.2, 0.25, 0.3, 0.35, 0.4, 0.45, 0.5, 0.55, and 0.6 milligrams per kilogram (mg/kg)] during Part A (single-dose range finding phase) and also during the once-daily repeated dosing phase in Part B, at steady state, 14 ± 4 days after each new dose (0.06, 0.08, and 0.12 mg/kg) is administered. One participant received the same dose at multiple visits (Part A) and one participant received the same daily dose during both dosing periods in Part B.
    End point type
    Primary
    End point timeframe
    Part A: 4 hours postdose and Part B: at steady state (14 ± 4 days after the start of each new dosage)
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Data for Primary Outcome Measures 1 were collected for presentation of results in a scatter plot and were not intended to be summarized due to the limited number of participants per treatment.
    End point values
    		 Entire Study Population
    Number of subjects analysed
    33 [4]
    Units: percentage of platelet inhibition
    arithmetic mean (standard deviation)
        Part A: 0.03 mg/kg (n=2)
    2 ( 2.83 )
        Part A: 0.05 mg/kg (n=2)
    0 ( 0 )
        Part A: 0.07 mg/kg (n=2)
    0 ( 0 )
        Part A: 0.08 mg/kg (n=18)
    7.7 ( 9.35 )
        Part A: 0.09 mg/kg (n=2)
    2.5 ( 3.54 )
        Part A: 0.11 mg/kg (n=1)
    0 ( 9999 )
        Part A: 0.13 mg/kg (n=2)
    9.5 ( 13.44 )
        Part A: 0.15 mg/kg (n=2)
    4 ( 0 )
        Part A: 0.2 mg/kg (n=2)
    0 ( 0 )
        Part A: 0.25 mg/kg (n=3)
    18 ( 18.52 )
        Part A: 0.3 mg/kg (n=6)
    42.3 ( 27.21 )
        Part A: 0.35 mg/kg (n=11)
    38 ( 28.46 )
        Part A: 0.4 mg/kg (n=14)
    39.1 ( 26.77 )
        Part A: 0.45 mg/kg (n=8)
    35.3 ( 27.16 )
        Part A: 0.5 mg/kg (n=7)
    55.9 ( 27.85 )
        Part A: 0.55 mg/kg (n=1)
    31 ( 9999 )
        Part A: 0.6 mg/kg (n=3)
    70.3 ( 19.22 )
        Part B: 0.06 mg/kg (n=8)
    38.6 ( 21.07 )
        Part B: 0.08 mg/kg (n=18)
    37.8 ( 25.86 )
        Part B: 0.12 mg/kg (n=8)
    48.1 ( 11.29 )
    Notes
    [4] - 9999=NA
    No statistical analyses for this end point

    Secondary: Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) of Prasugrel Inactive Metabolite

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    End point title
    		 Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) of Prasugrel Inactive Metabolite [5]
    End point description
    AUC of prasugrel inactive metabolite(s) from time 0 up to the last sampling time of 4 hours postdose [AUC(0-tlast)]. Improvements in bioanalytical methodology enabled direct measurement of Pras-AM from plasma, obviating the need to estimate its concentration from inactive downstream metabolite(s). Thus, the AUC of prasugrel inactive metabolite(s) was not analyzed.
    End point type
    Secondary
    End point timeframe
    Part A: 0.5, 1, 1.5, 2, 4 hours postdose
    Notes
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Analysis was only planned for Part A: AUC of prasugrel inactive metabolite(s) from time 0 up to the last sampling time of 4 hours postdose [AUC(0-tlast)].
    End point values
    		 Part A: Prasugrel Single Dose
    Number of subjects analysed
    0 [6]
    Units: nanograms*hour per milliliter (ng*hr/mL)
        median (full range (min-max))
    ( to )
    Notes
    [6] - No participants were analyzed.
    No statistical analyses for this end point

    Secondary: Number of Participants with Pain

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    End point title
    		 Number of Participants with Pain
    End point description
    The number of participants who answered "yes" to the first question in the Sickle Cell Disease Pain (SCD) Questionnaire is reported. Question 1: In the past 2 weeks, did you experience any sickle cell pain?
    End point type
    Secondary
    End point timeframe
    Part B: Baseline and Day14 ± 4 days postdose in each dosing period
    End point values
    		 Part B: Baseline Part B: Prasugrel Once-Daily Dose (0.06 mg/kg) Part B: Prasugrel Once-Daily Dose (0.08 mg/kg) Part B: Prasugrel Once-Daily Dose (0.12 mg/kg)
    Number of subjects analysed
    18
    9
    17
    8
    Units: participants
        number (not applicable)
    6
    4
    1
    2
    No statistical analyses for this end point

    Secondary: Number of Participants with Hemorrhagic Events Requiring Medical Intervention

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    End point title
    		 Number of Participants with Hemorrhagic Events Requiring Medical Intervention
    End point description
    Hemorrhagic events were determined by the study investigator. Medical intervention was defined as any medical attention resulting in therapy or further investigation, as determined by a trained medical professional.
    End point type
    Secondary
    End point timeframe
    Part B: Baseline up to Day 36
    End point values
    		 Part B: Baseline
    Number of subjects analysed
    18 [7]
    Units: participants
        number (not applicable)
    0
    Notes
    [7] - Participants who received at least 1 dose of prasugrel.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Part A and B
    Adverse event reporting additional description
    H7T-MC-TACX
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    15.1
    Reporting groups
    Reporting group title
    Prasugrel_Part A
    Reporting group description
    		 -

    Reporting group title
    Prasugrel_Part B
    Reporting group description
    		 -

    Reporting group title
    Prasugrel_Part A/B during Part A
    Reporting group description
    		 -

    Reporting group title
    Prasugrel_Part A/B during Part B
    Reporting group description
    		 -

    Serious adverse events
    		 Prasugrel_Part A Prasugrel_Part B Prasugrel_Part A/B during Part A Prasugrel_Part A/B during Part B
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 15 (13.33%)
    2 / 9 (22.22%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Congenital, familial and genetic disorders
    sickle cell anaemia with crisis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 15 (13.33%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    hypersplenism
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    acute chest syndrome
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (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
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Prasugrel_Part A Prasugrel_Part B Prasugrel_Part A/B during Part A Prasugrel_Part A/B during Part B
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 15 (33.33%)
    4 / 9 (44.44%)
    6 / 9 (66.67%)
    6 / 9 (66.67%)
    Injury, poisoning and procedural complications
    animal bite
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    1
    0
    0
    contusion
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    0
    1
    excoriation
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    1
    0
    1
    fall
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    1
    0
    0
    muscle strain
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    0
    0
    wound haemorrhage
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Congenital, familial and genetic disorders
    sickle cell anaemia
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 9 (0.00%)
    2 / 9 (22.22%)
    3 / 9 (33.33%)
         occurrences all number
    1
    0
    2
    4
    sickle cell anaemia with crisis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 15 (13.33%)
    1 / 9 (11.11%)
    2 / 9 (22.22%)
    1 / 9 (11.11%)
         occurrences all number
    3
    1
    2
    1
    General disorders and administration site conditions
    chest pain
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    0
    1
    pyrexia
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    1
    0
    1
    vessel puncture site pain
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Ear and labyrinth disorders
    middle ear effusion
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    0
    1
    Eye disorders
    eyelid bleeding
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Gastrointestinal disorders
    constipation
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    1
    0
    0
    tooth loss
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Reproductive system and breast disorders
    erectile dysfunction
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed [1]
    0 / 6 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    0
    penis disorder
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed [2]
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Respiratory, thoracic and mediastinal disorders
    asthma
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    2 / 9 (22.22%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    2
    0
    cough
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    2 / 15 (13.33%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    2
    1
    0
    0
    epistaxis
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    0
    1
    nasal congestion
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    1
    0
    1
    oropharyngeal pain
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    0
    1
    rhinorrhoea
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    2 / 9 (22.22%)
         occurrences all number
    1
    0
    0
    2
    wheezing
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Skin and subcutaneous tissue disorders
    rash
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    0
    1
    rash papular
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    1
    0
    skin swelling
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Musculoskeletal and connective tissue disorders
    arthralgia
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    0
    1
    back pain
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
         occurrences all number
    0
    0
    0
    1
    pain in extremity
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Infections and infestations
    hordeolum
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    1
    0
    0
    otitis media
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    1
    0
    viral infection
    alternative dictionary used: MedDRA 15.1
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 9 (11.11%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly.
    [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly.

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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? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    Data for the Primary Outcome Measures 1 and 2 were collected for presentation of results in a scatter plot and were not intended to be summarized due to the limited number of participants per treatment.
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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
    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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