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    Clinical Trial Results:
    A Multicenter, Open-Label, Single-arm Study to Assess the Efficacy and Safety of PF-06462700 Administered Intravenously at 40 mg/kg/day for 4 Days in Japanese Participants With Moderate and Above Aplastic Anemia

    Summary
    EudraCT number
    		 2021-002155-11
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    19 Apr 2021

    Results information
    Results version number
    		 v2
    This version publication date
    15 Apr 2022
    First version publication date
    21 Oct 2021
    Other versions
    		 v1 , v3
    Version creation reason
    • Correction of full data set
    Correct of data

    Trial information

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    Trial identification
    Sponsor protocol code
    B5411003
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04350606
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Pfizer Inc.
    Sponsor organisation address
    235 E 42nd Street, New York, NY 10017, United States,
    Public contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 18007181021, ClinicalTrials.gov_Inquiries@pfizer.com
    Scientific contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer Inc., 001 18007181021, ClinicalTrials.gov_Inquiries@pfizer.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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    09 Sep 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Apr 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To investigate the efficacy of PF- 06462700 administered intravenously at 40 mg/kg/day for 4 days in Japanese participants with moderate and above aplastic anemia.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Council for Harmonisation (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    25 Jul 2020
    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
    Japan: 3
    Worldwide total number of subjects
    3
    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)
    0
    Adolescents (12-17 years)
    1
    Adults (18-64 years)
    2
    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 single country from 25 July 2020 to 19 Apr 2021. Total 3 subjects signed the inform consent form (ICF). Out of which 0 subjects were screen failures, 3 actually enrolled into the study and assigned to a study treatment.

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

    Arms
    Arm title
    		 PF-06462700
    Arm description
    		 Subjects aged 2 years or greater than (>) 2 years with moderate and above severity aplastic anemia received PF-06462700 at a dose of 40 milligram per kilogram per day (mg/kg/day), intravenously (IV) for 4 days. Subjects after treatment were followed up for 24 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    PF-06462700
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received PF-06462700 dose of 40 mg/kg/day for 4 days.

    Number of subjects in period 1
    		PF-06462700
    Started
    3
    Treated
    3
    Follow-up
    3
    Completed
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    PF-06462700
    Reporting group description
    		 Subjects aged 2 years or greater than (>) 2 years with moderate and above severity aplastic anemia received PF-06462700 at a dose of 40 milligram per kilogram per day (mg/kg/day), intravenously (IV) for 4 days. Subjects after treatment were followed up for 24 weeks.

    Reporting group values
    		 PF-06462700 Total
    Number of subjects
    		 3 3
    Age Categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 1 1
        Adults (18-64 years)
    		 2 2
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 29.67 ( 16.56 ) -
    Gender Categorical
    Units: Subjects
        Female
    		 2 2
        Male
    		 1 1
    Race
    Units: Subjects
        White
    		 0 0
        Black or African American
    		 0 0
        Asian
    		 3 3
        American Indian or Alaska Native
    		 0 0
        Native Hawaiian or Other Pacific Islander
    		 0 0
        More than one race
    		 0 0
        Unknown or Not reported
    		 0 0
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 0 0
        Not Hispanic or Latino
    		 3 3
        Unknown or Not Reported
    		 0 0

    End points

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    End points reporting groups
    Reporting group title
    PF-06462700
    Reporting group description
    		 Subjects aged 2 years or greater than (>) 2 years with moderate and above severity aplastic anemia received PF-06462700 at a dose of 40 milligram per kilogram per day (mg/kg/day), intravenously (IV) for 4 days. Subjects after treatment were followed up for 24 weeks.

    Primary: Number of Subjects With Hematologic Response at Week 12

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    End point title
    		 Number of Subjects With Hematologic Response at Week 12 [1]
    End point description
    Hematologic response was considered to be “effective” when 2 or more of the following criteria were met: absolute neutrophil count greater than or equal to (>=) 500 per microliters, platelet count >=20,000 per microliters and reticulocyte count >=60,000 per microliters was observed. In this outcome measure, number of subjects with hematologic response classified as effective and not effective were reported. Improvement in counts that were dependent upon exogenously administered growth factors or transfusion, was not considered as fulfilling response criteria. Full analysis set (FAS) included subjects were assigned to investigational product and who took at least 1 dose of investigational product.
    End point type
    Primary
    End point timeframe
    Week 12 Follow-up Visit
    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: Only descriptive data was planned to be analyzed for this endpoint because of the limited sample size (n=3), no summary statistics were planned to be provided, and the result of primary endpoint was planned to be listed individually for each patients.
    End point values
    		 PF-06462700
    Number of subjects analysed
    3
    Units: Subjects
        Effective
    2
        Not Effective
    1
    No statistical analyses for this end point

    Secondary: Number of Subjects With Hematologic Response at Week 24

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    End point title
    		 Number of Subjects With Hematologic Response at Week 24
    End point description
    Hematologic response was considered to be “effective” when 2 or more of the following criteria were met: absolute neutrophil count >=500 per microliters, platelet count >=20,000 per microliters and reticulocyte count >=60,000 per microliters was observed. In this outcome measure, number of subjects with hematologic response classified as effective and not effective were reported. Improvement in counts that were dependent upon exogenously administered growth factors or transfusion, was not been considered as fulfilling response criteria. FAS included subjects were assigned to investigational product and who took at least 1 dose of investigational product.
    End point type
    Secondary
    End point timeframe
    Week 24 Follow-up Visit
    End point values
    		 PF-06462700
    Number of subjects analysed
    3
    Units: Subjects
        Effective
    2
        Not Effective
    1
    No statistical analyses for this end point

    Secondary: Absolute Neutrophil Count at Day 4, Weeks 1, 2, 4, 6, 8, 10, 12, 24

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    End point title
    		 Absolute Neutrophil Count at Day 4, Weeks 1, 2, 4, 6, 8, 10, 12, 24
    End point description
    FAS included subjects who were assigned to investigational product and who took at least 1 dose of investigational product. Here, "n" signifies the number of subjects evaluable at specific time points.
    End point type
    Secondary
    End point timeframe
    Treatment: Day 4; Follow-up: Week 1, 2, 4, 6, 8, 10, 12, 24
    End point values
    		 PF-06462700
    Number of subjects analysed
    3
    Units: Neutrophil cells per microliter
        Subject 1 : Day 4 (n=1)
    300
        Subject 1 : Week 1 (n=1)
    300
        Subject 1 : Week 2 (n=1)
    700
        Subject 1 : Week 4 (n=1)
    200
        Subject 1 : Week 6 (n=1)
    700
        Subject 1 : Week 8 (n=1)
    2100
        Subject 1 : Week 10 (n=1)
    2400
        Subject 1 : Week 12 (n=1)
    2300
        Subject 1 : Week 24 (n=1)
    2700
        Subject 2 : Day 4 (n=1)
    64
        Subject 2 : Week 1 (n=1)
    252
        Subject 2 : Week 2 (n=1)
    495
        Subject 2 : Week 4 (n=1)
    814
        Subject 2 : Week 6 (n=1)
    300
        Subject 2 : Week 8 (n=1)
    450
        Subject 2 : Week 10 (n=1)
    750
        Subject 2 : Week 12 (n=1)
    450
        Subject 2 : Week 24 (n=1)
    750
        Subject 3 : Day 4 (n=1)
    8
        Subject 3 : Week 1 (n=1)
    180
        Subject 3 : Week 2 (n=1)
    258
        Subject 3 : Week 4 (n=1)
    175
        Subject 3 : Week 6 (n=1)
    1679
        Subject 3 : Week 8 (n=1)
    2432
        Subject 3 : Week 10 (n=1)
    4335
        Subject 3 : Week 12 (n=1)
    5330
        Subject 3 : Week 24 (n=1)
    1755
    No statistical analyses for this end point

    Secondary: Platelet Count at Day 4, Weeks 1, 2, 4, 6, 8, 10, 12, 24

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    End point title
    		 Platelet Count at Day 4, Weeks 1, 2, 4, 6, 8, 10, 12, 24
    End point description
    FAS included subjects who were assigned to investigational product and who took at least 1 dose of investigational product. Here, "n" signifies the number of subjects evaluable at specific time points.
    End point type
    Secondary
    End point timeframe
    Treatment: Day 4; Follow-up: Week 1, 2, 4, 6, 8, 10, 12, 24
    End point values
    		 PF-06462700
    Number of subjects analysed
    3
    Units: Platelet cells per microliter
        Subject 1 : Day 4 (n=1)
    34000
        Subject 1 : Week 1 (n=1)
    23000
        Subject 1 : Week 2 (n=1)
    9000
        Subject 1 : Week 4 (n=1)
    11000
        Subject 1 : Week 6 (n=1)
    22000
        Subject 1 : Week 8 (n=1)
    46000
        Subject 1 : Week 10 (n=1)
    72000
        Subject 1 : Week 12 (n=1)
    77000
        Subject 1 : Week 24 (n=1)
    139000
        Subject 2 : Day 4 (n=1)
    34000
        Subject 2 : Week 1 (n=1)
    8000
        Subject 2 : Week 2 (n=1)
    56000
        Subject 2 : Week 4 (n=1)
    15000
        Subject 2 : Week 6 (n=1)
    21000
        Subject 2 : Week 8 (n=1)
    21000
        Subject 2 : Week 10 (n=1)
    37000
        Subject 2 : Week 12 (n=1)
    47000
        Subject 2 : Week 24 (n=1)
    58000
        Subject 3 : Day 4 (n=1)
    21000
        Subject 3 : Week 1 (n=1)
    7000
        Subject 3 : Week 2 (n=1)
    40000
        Subject 3 : Week 4 (n=1)
    9000
        Subject 3 : Week 6 (n=1)
    8000
        Subject 3 : Week 8 (n=1)
    36000
        Subject 3 : Week 10 (n=1)
    45000
        Subject 3 : Week 12 (n=1)
    88000
        Subject 3 : Week 24 (n=1)
    16000
    No statistical analyses for this end point

    Secondary: Reticulocyte Count at Day 4, Weeks 1, 2, 4, 6, 8, 10, 12, 24

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    End point title
    		 Reticulocyte Count at Day 4, Weeks 1, 2, 4, 6, 8, 10, 12, 24
    End point description
    FAS included subjects who were assigned to investigational product and who took at least 1 dose of investigational product. Here, "n" signifies the number of subjects evaluable at specific time points.
    End point type
    Secondary
    End point timeframe
    Treatment: Day 4; Follow-up: Week 1, 2, 4, 6, 8, 10, 12, 24
    End point values
    		 PF-06462700
    Number of subjects analysed
    3
    Units: Reticulocyte cells per microliter
        Subject 1 : Day 4 (n=1)
    14100
        Subject 1 : Week 1 (n=1)
    7350
        Subject 1 : Week 2 (n=1)
    8840
        Subject 1 : Week 4 (n=1)
    17780
        Subject 1 : Week 6 (n=1)
    34650
        Subject 1 : Week 8 (n=1)
    90090
        Subject 1 : Week 10 (n=1)
    113600
        Subject 1 : Week 12 (n=1)
    84300
        Subject 1 : Week 24 (n=1)
    53760
        Subject 2 : Day 4 (n=1)
    5000
        Subject 2 : Week 1 (n=1)
    6000
        Subject 2 : Week 2 (n=1)
    6000
        Subject 2 : Week 4 (n=1)
    12000
        Subject 2 : Week 6 (n=1)
    16000
        Subject 2 : Week 8 (n=1)
    37000
        Subject 2 : Week 10 (n=1)
    44000
        Subject 2 : Week 12 (n=1)
    69000
        Subject 2 : Week 24 (n=1)
    85000
        Subject 3 : Day 4 (n=1)
    14400
        Subject 3 : Week 1 (n=1)
    10800
        Subject 3 : Week 2 (n=1)
    9600
        Subject 3 : Week 4 (n=1)
    14700
        Subject 3 : Week 6 (n=1)
    11200
        Subject 3 : Week 8 (n=1)
    26300
        Subject 3 : Week 10 (n=1)
    230200
        Subject 3 : Week 12 (n=1)
    261200
        Subject 3 : Week 24 (n=1)
    57600
    No statistical analyses for this end point

    Secondary: Number of Subjects who Survived During the Study

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    End point title
    		 Number of Subjects who Survived During the Study
    End point description
    In this endpoint, number of subjects who survived during the study were observed. FAS included subjects who were assigned to investigational product and who took at least 1 dose of investigational product.
    End point type
    Secondary
    End point timeframe
    Screening (up to 28 days prior to Day 1 of treatment) up to 24 weeks of follow-up (approximately up to 28 weeks)
    End point values
    		 PF-06462700
    Number of subjects analysed
    3
    Units: Subjects
    3
    No statistical analyses for this end point

    Secondary: Number of Subjects With Transfusion Independence at Weeks 12 and 24

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    End point title
    		 Number of Subjects With Transfusion Independence at Weeks 12 and 24
    End point description
    Transfusion independence at Week 12 was defined as when subjects did not have any transfusion records from the time of the first dose of the investigational product at Day 1 to the day of Week 12 visit (inclusive). Transfusion independence at Week 24 was defined as when subjects did not have any transfusion records from the day after Week 12 visit to the day of Week 24 visit (inclusive). FAS included subjects who were assigned to investigational product and who took at least 1 dose of investigational product.
    End point type
    Secondary
    End point timeframe
    Week 12 Transfusion Independence: Day 1 of Treatment up to Week 12 Follow-up Visit (approximately 12 weeks); Week 24 Transfusion Independence: Day after Week 12 Follow-up visit to Week 24 Follow-up Visit (approximately 12 weeks)
    End point values
    		 PF-06462700
    Number of subjects analysed
    3
    Units: Subjects
        Week 12 Transfusion Independence
    0
        Week 24 Transfusion Independence
    2
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Screening up to 24 weeks of follow-up (approximately up to 28 weeks)
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.0
    Reporting groups
    Reporting group title
    PF-06462700
    Reporting group description
    		 Subjects aged 2 years or >2 years with moderate and above severity aplastic anemia received PF-06462700 at a dose of 40 mg/kg/day, IV for 4 days. Subjects after treatment were followed up for 24 weeks.

    Serious adverse events
    		 PF-06462700
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 3 (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
    		 PF-06462700
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 3 (100.00%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    2 / 3 (66.67%)
         occurrences all number
    3
    General disorders and administration site conditions
    Infusion site extravasation
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Feeling abnormal
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Oedema
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Immune system disorders
    Hypogammaglobulinaemia
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Serum sickness
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Reproductive system and breast disorders
    Genital haemorrhage
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Productive cough
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Blood bilirubin increased
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Blood creatinine increased
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    C-reactive protein increased
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    2
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Lymphocyte count decreased
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Oxygen saturation abnormal
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    White blood cell count decreased
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Nervous system disorders
    Tremor
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Abdominal pain
         subjects affected / exposed
    2 / 3 (66.67%)
         occurrences all number
    2
    Dental caries
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Nausea
         subjects affected / exposed
    2 / 3 (66.67%)
         occurrences all number
    2
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Gastrointestinal disorder
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Proctalgia
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Dry skin
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Nail bed inflammation
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Renal and urinary disorders
    Proteinuria
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Renal impairment
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Endocrine disorders
    Adrenal insufficiency
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Infections and infestations
    Cytomegalovirus viraemia
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Cytomegalovirus infection
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Staphylococcal infection
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    1
    Metabolism and nutrition disorders
    Hypokalaemia
         subjects affected / exposed
    1 / 3 (33.33%)
         occurrences all number
    2
    Hyperglycaemia
         subjects affected / exposed
    2 / 3 (66.67%)
         occurrences all number
    2

    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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