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    Clinical Trial Results:
    A Phase 2, Randomized, Multicenter, Placebo-Controlled, Double-Blind, Parallel-Group Study, with an Open-Label Extension to Evaluate the Efficacy, Safety, and Pharmacokinetics of E5501 in Subjects with Chronic Hepatitis C Virus Related Thrombocytopenia who are Potential Candidates for Antiviral Treatment

    Summary
    EudraCT number
    		 2010-024479-20
    Trial protocol
    		 DE   BG  
    Global end of trial date
    01 May 2014

    Results information
    Results version number
    		 v1
    This version publication date
    10 Mar 2016
    First version publication date
    05 Aug 2015
    Other versions
    		 v2

    Trial information

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    Trial identification
    Sponsor protocol code
    E5501-G000-203
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01355289
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Eisai
    Sponsor organisation address
    155 Tice Boulevard, Woodcliff Lake, United States, 07677
    Public contact
    Medical Information, Eisai Limited, +44 08456761400, LmedInfo@eisai.net
    Scientific contact
    Medical Information, Eisai Limited, +44 08456761400, LmedInfo@eisai.net
    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
    01 May 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    01 May 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of E5501 by measuring platelet response in subjects with chronic hepatitis C virus (HCV)-related thrombocytopenia who require antiviral treatment
    Protection of trial subjects
    This study was performed in full compliance with International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and all applicable local Good Clinical Practice (GCP) and regulations. All required study documentation is archived as required by regulatory authorities.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    10 Nov 2011
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Bulgaria: 3
    Country: Number of subjects enrolled
    France: 3
    Country: Number of subjects enrolled
    Germany: 5
    Country: Number of subjects enrolled
    Israel: 9
    Country: Number of subjects enrolled
    United States: 45
    Worldwide total number of subjects
    65
    EEA total number of subjects
    11
    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)
    60
    From 65 to 84 years
    5
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 The Screening Period encompassed 14 days ±7 days. Prerandomization assessments took place in all subjects who had provided informed consent.

    Period 1
    Period 1 title
    Core Study
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Carer, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Placebo, was administered orally, once daily for upto 21 days.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Once daily.

    Arm title
    		 Avatrombopag 10 mg
    Arm description
    		 Avatrombopag 10 mg, was administered orally, once daily, preferably with food for upto 21 days.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Avatrombopag
    Investigational medicinal product code
    E5501
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    10 mg, tablet form, orally, once daily.

    Arm title
    		 Avatrombopag 20 mg
    Arm description
    		 Avatrombopag 20 mg, was administered orally, once daily, preferably with food for upto 21 days.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Avatrombopag
    Investigational medicinal product code
    E5501
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    20 mg, tablet form, orally, once daily.

    Arm title
    		 Avatrombopag 30 mg
    Arm description
    		 Avatrombopag 30 mg, was administered orally, once daily, preferably with food for upto 21 days.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Avatrombopag
    Investigational medicinal product code
    E5501
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    30 mg, tablet form, orally, once daily.

    Number of subjects in period 1
    		Placebo Avatrombopag 10 mg Avatrombopag 20 mg Avatrombopag 30 mg
    Started
    17
    16
    18
    14
    Completed
    16
    16
    18
    12
    Not completed
    1
    0
    0
    2
         Adverse event, non-fatal
    1
    -
    -
    -
         Not specified
    -
    -
    -
    1
         Inadequate therapeutic effect
    -
    -
    -
    1
    Period 2
    Period 2 title
    Open Label Extension (OLE)
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Avatrombopag (Open label extension)
    Arm description
    		 Avatrombopag was initiated at a dose of 20 mg, once daily in the OLE period. The avatrombopag dose was titrated up or down in accordance with their individual response within the range of a minimum of 5 mg and a maximum of 50 mg for up to 48 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Avatrombopag
    Investigational medicinal product code
    E5501
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    5-50 mg, tablet form, orally, once daily.

    Number of subjects in period 2
    		Avatrombopag (Open label extension)
    Started
    62
    Completed
    28
    Not completed
    34
         Adverse event, non-fatal
    1
         Not specified
    3
         Lost to follow-up
    1
         Lack of efficacy
    29

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo, was administered orally, once daily for upto 21 days.

    Reporting group title
    Avatrombopag 10 mg
    Reporting group description
    		 Avatrombopag 10 mg, was administered orally, once daily, preferably with food for upto 21 days.

    Reporting group title
    Avatrombopag 20 mg
    Reporting group description
    		 Avatrombopag 20 mg, was administered orally, once daily, preferably with food for upto 21 days.

    Reporting group title
    Avatrombopag 30 mg
    Reporting group description
    		 Avatrombopag 30 mg, was administered orally, once daily, preferably with food for upto 21 days.

    Reporting group values
    		 Placebo Avatrombopag 10 mg Avatrombopag 20 mg Avatrombopag 30 mg Total
    Number of subjects
    		 17 16 18 14 65
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 50.2 ( 7.96 ) 55.3 ( 8.06 ) 54.9 ( 7.38 ) 53.6 ( 7.26 ) -
    Gender categorical
    Units: Subjects
        Female
    		 3 4 5 5 17
        Male
    		 14 12 13 9 48

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo, was administered orally, once daily for upto 21 days.

    Reporting group title
    Avatrombopag 10 mg
    Reporting group description
    		 Avatrombopag 10 mg, was administered orally, once daily, preferably with food for upto 21 days.

    Reporting group title
    Avatrombopag 20 mg
    Reporting group description
    		 Avatrombopag 20 mg, was administered orally, once daily, preferably with food for upto 21 days.

    Reporting group title
    Avatrombopag 30 mg
    Reporting group description
    		 Avatrombopag 30 mg, was administered orally, once daily, preferably with food for upto 21 days.
    Reporting group title
    Avatrombopag (Open label extension)
    Reporting group description
    		 Avatrombopag was initiated at a dose of 20 mg, once daily in the OLE period. The avatrombopag dose was titrated up or down in accordance with their individual response within the range of a minimum of 5 mg and a maximum of 50 mg for up to 48 weeks.

    Primary: Number of participants who achieved Platelet Response (greater than or equal to 100 x 109/L) by Day 21 of Treatment Period A1 of Core Study

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    End point title
    		 Number of participants who achieved Platelet Response (greater than or equal to 100 x 109/L) by Day 21 of Treatment Period A1 of Core Study
    End point description
    Responders are defined as a participant having a platelet count of greater than or equal to 100x109/L by Day 21 starting from an average baseline platelet count of greater than 20 x 109/L to less than or equal to 70 x 109/L.
    End point type
    Primary
    End point timeframe
    Baseline to Day 21
    End point values
    		 Placebo Avatrombopag 10 mg Avatrombopag 20 mg Avatrombopag 30 mg
    Number of subjects analysed
    17
    16
    18
    14
    Units: Participants
    number (not applicable)
        Yes
    1
    6
    12
    9
        No
    16
    10
    6
    5
    Statistical analysis title
    		 Difference of response rate (10 mg) vs placebo
    Comparison groups
    Avatrombopag 10 mg v Placebo
    Number of subjects included in analysis
    33
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0236
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Median difference (final values)
    Point estimate
    31.62
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 5.39
         upper limit
    		 57.84
    Statistical analysis title
    		 Difference of response rate (20 mg) vs placebo
    Comparison groups
    Placebo v Avatrombopag 20 mg
    Number of subjects included in analysis
    35
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0003
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Median difference (final values)
    Point estimate
    60.78
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 36.3
         upper limit
    		 85.27
    Statistical analysis title
    		 Difference of response rate (30 mg) vs placebo
    Comparison groups
    Placebo v Avatrombopag 30 mg
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0003
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Median difference (final values)
    Point estimate
    58.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 30.92
         upper limit
    		 85.88

    Secondary: Change from Baseline of Local Platelet Count by Visit during Treatment Period A1 of Core Study

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    End point title
    		 Change from Baseline of Local Platelet Count by Visit during Treatment Period A1 of Core Study
    End point description
    Missing platelet counts were imputed using LOCF (last observation carried forward) approach for subjects who achieved platelet response at prior visits.
    End point type
    Secondary
    End point timeframe
    Baseline, Day 7 and Day 14
    End point values
    		 Placebo Avatrombopag 10 mg Avatrombopag 20 mg Avatrombopag 30 mg
    Number of subjects analysed
    17
    16
    18
    14
    Units: x109/L
    arithmetic mean (standard deviation)
        Day 7
    -0.1 ( 7.15 )
    19.8 ( 17.59 )
    26.5 ( 22.06 )
    30.9 ( 37.65 )
        Day 14
    -0.2 ( 13.79 )
    29.2 ( 18.32 )
    57.2 ( 31.39 )
    55.4 ( 37.47 )
    No statistical analyses for this end point

    Secondary: Number of Participants who achieved Platelet Count greater than 30 X 109/L from Baseline to Day 21 during Treatment Period A1 of Core Study

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    End point title
    		 Number of Participants who achieved Platelet Count greater than 30 X 109/L from Baseline to Day 21 during Treatment Period A1 of Core Study
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to Day 21
    End point values
    		 Placebo Avatrombopag 10 mg Avatrombopag 20 mg Avatrombopag 30 mg
    Number of subjects analysed
    17
    16
    18
    14
    Units: Participants
    number (not applicable)
        Yes
    1
    9
    16
    11
        No
    16
    7
    2
    3
    No statistical analyses for this end point

    Secondary: Number of Participants who initiated Antiviral Treatment by Day 21 of Period A1 of Core Study

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    End point title
    		 Number of Participants who initiated Antiviral Treatment by Day 21 of Period A1 of Core Study
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to Day 21
    End point values
    		 Placebo Avatrombopag 10 mg Avatrombopag 20 mg Avatrombopag 30 mg
    Number of subjects analysed
    17
    16
    18
    14
    Units: Participants
    number (not applicable)
        Yes
    1
    6
    13
    9
        No
    16
    10
    5
    5
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Through the end of study
    Adverse event reporting additional description
    Safety Analysis Set was used which combines data of the Core and Extension Phase and includes subjects who had at least 1 dose of avatrombopag. Placebo treatment arm was excluded since not part of study design for the Extension Phase.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16
    Reporting groups
    Reporting group title
    Avatrombopag
    Reporting group description
    		 During the core study, participants were administered a fixed dose of Avatrombopag 10mg, 20mg, or 30mg,orally, once daily, preferably with food for upto 21 days. The participants initiated Open label extension with Avontrombopag 20 mg, once daily. The avotrambopag dose was titrated up or down in accordance with their individual response, within the range of a minimum of 5mg and a maximum of 50 mg.

    Serious adverse events
    		 Avatrombopag
    Total subjects affected by serious adverse events
         subjects affected / exposed
    13 / 64 (20.31%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Nervous system disorders
    Paraesthesia
         subjects affected / exposed
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    2 / 64 (3.13%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Leukopenia
         subjects affected / exposed
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Neutropenia
         subjects affected / exposed
    2 / 64 (3.13%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Pancytopenia
         subjects affected / exposed
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    2 / 64 (3.13%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hepatobiliary disorders
    Hepatic mass
         subjects affected / exposed
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal failure acute
         subjects affected / exposed
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Gastroenteritis
         subjects affected / exposed
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    Hyperglycaemia
         subjects affected / exposed
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hyperuricaemia
         subjects affected / exposed
    1 / 64 (1.56%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Avatrombopag
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    55 / 64 (85.94%)
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    4 / 64 (6.25%)
         occurrences all number
    4
    Headache
         subjects affected / exposed
    12 / 64 (18.75%)
         occurrences all number
    17
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    21 / 64 (32.81%)
         occurrences all number
    31
    Leukopenia
         subjects affected / exposed
    14 / 64 (21.88%)
         occurrences all number
    20
    Lymphopenia
         subjects affected / exposed
    5 / 64 (7.81%)
         occurrences all number
    7
    Neutropenia
         subjects affected / exposed
    20 / 64 (31.25%)
         occurrences all number
    25
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    8 / 64 (12.50%)
         occurrences all number
    9
    Chills
         subjects affected / exposed
    13 / 64 (20.31%)
         occurrences all number
    14
    Fatigue
         subjects affected / exposed
    16 / 64 (25.00%)
         occurrences all number
    17
    Influenza like illness
         subjects affected / exposed
    11 / 64 (17.19%)
         occurrences all number
    13
    Injection site erythema
         subjects affected / exposed
    6 / 64 (9.38%)
         occurrences all number
    7
    Irritability
         subjects affected / exposed
    7 / 64 (10.94%)
         occurrences all number
    7
    Oedema peripheral
         subjects affected / exposed
    6 / 64 (9.38%)
         occurrences all number
    6
    Pyrexia
         subjects affected / exposed
    9 / 64 (14.06%)
         occurrences all number
    13
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    6 / 64 (9.38%)
         occurrences all number
    6
    Abdominal pain upper
         subjects affected / exposed
    5 / 64 (7.81%)
         occurrences all number
    6
    Ascites
         subjects affected / exposed
    6 / 64 (9.38%)
         occurrences all number
    7
    Diarrhoea
         subjects affected / exposed
    11 / 64 (17.19%)
         occurrences all number
    12
    Dyspepsia
         subjects affected / exposed
    4 / 64 (6.25%)
         occurrences all number
    4
    Haemorrhoids
         subjects affected / exposed
    4 / 64 (6.25%)
         occurrences all number
    6
    Nausea
         subjects affected / exposed
    20 / 64 (31.25%)
         occurrences all number
    22
    Vomiting
         subjects affected / exposed
    8 / 64 (12.50%)
         occurrences all number
    10
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    9 / 64 (14.06%)
         occurrences all number
    10
    Dyspnoea
         subjects affected / exposed
    4 / 64 (6.25%)
         occurrences all number
    4
    Dyspnoea exertional
         subjects affected / exposed
    4 / 64 (6.25%)
         occurrences all number
    5
    Epistaxis
         subjects affected / exposed
    6 / 64 (9.38%)
         occurrences all number
    7
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    15 / 64 (23.44%)
         occurrences all number
    15
    Rash
         subjects affected / exposed
    12 / 64 (18.75%)
         occurrences all number
    16
    Psychiatric disorders
    Depression
         subjects affected / exposed
    5 / 64 (7.81%)
         occurrences all number
    6
    Insomnia
         subjects affected / exposed
    13 / 64 (20.31%)
         occurrences all number
    13
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    4 / 64 (6.25%)
         occurrences all number
    4
    Upper respiratory tract infection
         subjects affected / exposed
    4 / 64 (6.25%)
         occurrences all number
    6
    Metabolism and nutrition disorders
    Hyperuricaemia
         subjects affected / exposed
    4 / 64 (6.25%)
         occurrences all number
    5

    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? 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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