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    Clinical Trial Results:
    A randomised, open-label, placebo-controlled, single centre study in healthy male volunteers to explore efficacy, safety and tolerability of single doses of low molecular weight dextran sulfate (LMW-DS) in combination with recombinant human granulocyte colony stimulating factor (rhG-CSF, filgrastim) and in comparison with plerixafor treatment and placebo

    Summary
    EudraCT number
    		 2014-000659-10
    Trial protocol
    		 SE  
    Global end of trial date
    13 Sep 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    11 Jul 2019
    First version publication date
    11 Jul 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    LMW-DS-103
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    TikoMed AB
    Sponsor organisation address
    P.O. Box 81, 263 03 VIKEN, Sweden,
    Public contact
    CEO, TikoMed AB, regulatory@tikomed.com
    Scientific contact
    CEO, TikoMed AB, regulatory@tikomed.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    13 Sep 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    13 Sep 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Sep 2014
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To determine the blood levels of CD34+ cells at different time points after treatment with filgrastim (for 5 days) in combination with low molecular weight dextran sulfate (LMW-DS) compared to filgrastim treatment (for 5 days) in combination with plerixafor or NaCl.
    Protection of trial subjects
    The potential study subject was informed that by signing the ICF he approved that authorized representatives from Sponsor and CTC, the concerned IEC and CA had direct access to his medical records for verification of clinical study procedures. An authorization from the hospital for access to medical records by the Monitor was available, as required by local legislation. The subject had the right to request access to his/her personal data and rectification of any data that was not correct and/or complete. The Investigator filed a Subject Identification List which included sufficient information to link records, i.e. the CRF and clinical records. This list will be preserved for possible future inspections/audits but has not been made available to the Sponsor except for monitoring or auditing purposes. As a precaution to minimize any hypersensitivity reactions to LMW-DS, an oral dose of Klemastin (antihistamine), 1 mg, was given to all subjects in Group 1, 2 h before start of the LMW-DS infusion. During the initial 4 days of filgrastim treatment, the subjects came to the clinic in the morning and received a subcutaneous injection of filgrastim. As a safety precaution, the subjects stayed at the clinic for 2 hours after the filgrastim injection. On day 5, the subjects arrived in the morning for filgrastim treatment followed by LMW-DS i.v. infusion (Group 1), plerixafor s.c. injection (Group 2) or 10-min i.v. infusion NaCl (Group 3). Blood samples, vital signs, and electrocardiogram (ECG) were recorded prior to treatment with LMW-DS and at several time points up to 24 h after the day 5 dose administration. Each subject stayed at the clinic until approximately 24 h post start of dose administration of LMW-DS/plerixafor/NaCl.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    27 May 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
    Sweden: 15
    Worldwide total number of subjects
    15
    EEA total number of subjects
    15
    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)
    15
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The subjects were recruited from a list of healthy volunteers.

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 15
    Number of subjects completed
    		 11

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Adverse event, non-fatal: 2
    Reason: Number of subjects
    		 Consent withdrawn by subject: 2
    Period 1
    Period 1 title
    Overall period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group 1 - Experimental Treatment
    Arm description
    		 LMW-DS + Filgrastim
    Arm type
    		 Experimental

    Investigational medicinal product name
    LMW-DS 20 mg/ml
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    20 mg/mL; 18 mg/kg administered by a short-term 10-min intravenous infusion on Day 5.

    Investigational medicinal product name
    Filgrastim
    Investigational medicinal product code
    Other name
    Neupogen
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    0.96 mg/mL; 10 μg/kg administered subcutaneously once daily for 5 days.

    Arm title
    		 Group 2 - Plerixafor control
    Arm description
    		 Plerixafor + Filgrastim
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Filgrastim
    Investigational medicinal product code
    Other name
    Neupogen
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    0.96 mg/mL; 10 μg/kg administered subcutaneously once daily for 5 days.

    Investigational medicinal product name
    Plerixafor
    Investigational medicinal product code
    Other name
    Mozobil
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    20 mg/mL; 240 μg/kg administered subcutaneously on Day 5.

    Arm title
    		 Group 3 - NaCl placebo control
    Arm description
    		 NaCl + Filgrastim
    Arm type
    		 Placebo

    Investigational medicinal product name
    Filgrastim
    Investigational medicinal product code
    Other name
    Neupogen
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    0.96 mg/mL; 10 μg/kg administered subcutaneously once daily for 5 days.

    Investigational medicinal product name
    NaCl
    Investigational medicinal product code
    Other name
    Sodium Chloride
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    9 mg/mL; 0.9 mL/kg administered intravenously on Day 5.

    Number of subjects in period 1 [1]
    		Group 1 - Experimental Treatment Group 2 - Plerixafor control Group 3 - NaCl placebo control
    Started
    3
    4
    4
    Completed
    3
    4
    4
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: In total, 15 subjects were enrolled. Two (2) subjects withdrew consent before any treatment and two (2) subjects withdrew from the study due to AEs during the filgrastim pre-assignment treatment. None of these four (4) subjects were included in the overall study period and therefore only 11 subjects are included in the Full / Safety Analysis Set.

    Baseline characteristics

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

    Reporting group values
    		 Overall period Total
    Number of subjects
    		 11 11
    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)
    		 0 0
        Adults (18-64 years)
    		 11 11
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
        Not recorded
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    		 30 (23 to 44) -
    Gender categorical
    Units: Subjects
        Female
    		 0 0
        Male
    		 11 11
    Weight
    Units: kilogram(s)
        arithmetic mean (full range (min-max))
    		 80.8 (67.8 to 90.3) -

    End points

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    End points reporting groups
    Reporting group title
    Group 1 - Experimental Treatment
    Reporting group description
    		 LMW-DS + Filgrastim

    Reporting group title
    Group 2 - Plerixafor control
    Reporting group description
    		 Plerixafor + Filgrastim

    Reporting group title
    Group 3 - NaCl placebo control
    Reporting group description
    		 NaCl + Filgrastim

    Primary: Absolute number of CD34+ cells

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    End point title
    		 Absolute number of CD34+ cells [1]
    End point description
    End point type
    Primary
    End point timeframe
    From -30 min pre-dose to 24 h after dose
    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: Due to premature termination of the study for efficacy reasons, the statistical analysis was not as extensive as described in the clinical study protocol. Only descriptive statistics have been described in the abbreviated study report.
    End point values
    		 Group 1 - Experimental Treatment Group 2 - Plerixafor control Group 3 - NaCl placebo control
    Number of subjects analysed
    3
    4
    4
    Units: x 10^6/L
    arithmetic mean (standard deviation)
        Pre-dose (-30 min)
    82.0 ± 24.1
    58.3 ± 18.6
    44.3 ± 7.5
        1 h after dose
    107.0 ± 29.5
    123.8 ± 52.7
    63.5 ± 11.0
        3 h after dose
    121.0 ± 33.9
    143.3 ± 49.0
    75.3 ± 16.5
        6 h after dose
    118.3 ± 44.8
    167.3 ± 44.4
    78.0 ± 16.0
        9 h after dose
    123.7 ± 34.0
    203.5 ± 59.7
    90.8 ± 10.5
        24 h after dose
    107.0 ± 30.1
    159.5 ± 66.6
    72.0 ± 10.9
    No statistical analyses for this end point

    Secondary: Hepatocyte growth factor

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    End point title
    		 Hepatocyte growth factor
    End point description
    End point type
    Secondary
    End point timeframe
    From -30 min pre-dose to 24 h after dose.
    End point values
    		 Group 1 - Experimental Treatment Group 2 - Plerixafor control Group 3 - NaCl placebo control
    Number of subjects analysed
    3
    4
    4
    Units: pg/mL
    arithmetic mean (standard deviation)
        Pre-dose (-30 min)
    2057.0 ± 292.9
    1976.8 ± 235.6
    1975.3 ± 402.3
        1 h
    109258.0 ± 21779.9
    6745.3 ± 1176.7
    6920.0 ± 778.1
        3 h
    116479.3 ± 19308.3
    9239.0 ± 3624.3
    7804.0 ± 1534.7
        6 h
    143585.0 ± 44596.1
    8978.5 ± 1578.4
    8519.5 ± 1420.0
        9 h
    93078.7 ± 23685.0
    9715.0 ± 1702.4
    8652.3 ± 793.6
        24 h
    16459.0 ± 7576.8
    8509.8 ± 1854.9
    8086.8 ± 213.9
    No statistical analyses for this end point

    Secondary: Stromal cell-derived factor-1

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    End point title
    		 Stromal cell-derived factor-1
    End point description
    End point type
    Secondary
    End point timeframe
    From -30 min pre-dose until 24 h after dose.
    End point values
    		 Group 1 - Experimental Treatment Group 2 - Plerixafor control Group 3 - NaCl placebo control
    Number of subjects analysed
    3
    4
    4
    Units: pg/mL
    arithmetic mean (standard deviation)
        Pre-dose (-30 min)
    1314.3 ± 124.7
    1437.3 ± 93.7
    1500.5 ± 312.5
        1 h
    3074.0 ± 438.5
    2499.8 ± 300.0
    1541.8 ± 330.1
        3 h
    2135.7 ± 226.7
    2281.8 ± 368.1
    1475.5 ± 320.0
        6 h
    1560.3 ± 250.5
    2238.3 ± 374.2
    1518.8 ± 285.8
        9 h
    1228.0 ± 69.5
    2035.8 ± 235.9
    1512.0 ± 303.4
        24 h
    1208.7 ± 199.2
    1681.0 ± 175.8
    1494.8 ± 199.1
    No statistical analyses for this end point

    Secondary: Lymphocytes

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    End point title
    		 Lymphocytes
    End point description
    End point type
    Secondary
    End point timeframe
    From screening until Follow-up 2 visit (day 19)
    End point values
    		 Group 1 - Experimental Treatment Group 2 - Plerixafor control Group 3 - NaCl placebo control
    Number of subjects analysed
    3
    4
    4
    Units: x 10^9/L
    arithmetic mean (standard deviation)
        Screening
    2.37 ± 0.64
    2.20 ± 0.36
    1.35 ± 0.17
        Pre-dose (-120 min)
    4.67 ± 2.10
    3.95 ± 0.58
    2.68 ± 0.80
        Pre-dose (-30 min)
    4.10 ± 1.51
    3.80 ± 0.80
    2.43 ± 0.38
        15 min
    6.77 ± 2.04
    6.00 ± 1.42
    3.30 ± 0.77
        30 min
    7.17 ± 1.36
    5.68 ± 0.53
    3.43 ± 0.57
        1 h
    8.80 ± 2.29
    6.88 ± 2.01
    2.63 ± 0.33
        3 h
    9.50 ± 3.36
    7.20 ± 0.36
    2.33 ± 0.93
        6 h
    8.03 ± 1.43
    8.85 ± 1.66
    2.47 ± 0.57
        9 h
    6.30 ± 1.85
    7.63 ± 1.07
    3.23 ± 0.81
        24 h
    6.70 ± 3.34
    6.00 ± 0.52
    2.60 ± 0.99
        Follow-up 2 (day 19)
    1.70 ± 0.87
    1.45 ± 0.35
    1.05 ± 0.10
    No statistical analyses for this end point

    Secondary: Clinical chemistry - Albumin

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    End point title
    		 Clinical chemistry - Albumin
    End point description
    End point type
    Secondary
    End point timeframe
    At baseline and Follow-up visit 2 (day 19).
    End point values
    		 Group 1 - Experimental Treatment Group 2 - Plerixafor control Group 3 - NaCl placebo control
    Number of subjects analysed
    3
    4
    4
    Units: subjects
        Baseline - Normal
    3
    4
    4
        Baseline - NCS
    0
    0
    0
        Baseline - CS
    0
    0
    0
        Baseline - ND/Miss
    0
    0
    0
        Follow-up 2 - Normal
    3
    4
    4
        Follow-up 2 - NCS
    0
    0
    0
        Follow-up 2 - CS
    0
    0
    0
        Follow-up 2 - ND/Miss
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Clinical chemistry - Alkaline phospatase

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    End point title
    		 Clinical chemistry - Alkaline phospatase
    End point description
    End point type
    Secondary
    End point timeframe
    At baseline and Follow-up visit 2 (day 19).
    End point values
    		 Group 1 - Experimental Treatment Group 2 - Plerixafor control Group 3 - NaCl placebo control
    Number of subjects analysed
    3
    4
    4
    Units: subjects
        Baseline - Normal
    3
    4
    4
        Baseline - NCS
    0
    0
    0
        Baseline - CS
    0
    0
    0
        Baseline - ND/Miss
    0
    0
    0
        Follow-up 2 - Normal
    3
    4
    4
        Follow-up 2 - NCS
    0
    0
    0
        Follow-up - CS
    0
    0
    0
        Follow-up - ND/Miss
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Clinical Chemistry - Alanine Aminotransferase

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    End point title
    		 Clinical Chemistry - Alanine Aminotransferase
    End point description
    End point type
    Secondary
    End point timeframe
    At baseline and Follow-up visit 2 (day 19).
    End point values
    		 Group 1 - Experimental Treatment Group 2 - Plerixafor control Group 3 - NaCl placebo control
    Number of subjects analysed
    3
    4
    4
    Units: subjects
        Baseline - Normal
    3
    4
    4
        Baseline - NCS
    0
    0
    0
        Baseline - CS
    0
    0
    0
        Baseline - ND/Miss
    0
    0
    0
        Follow-up 2 - Normal
    2
    4
    4
        Follow-up 2 - NCS
    1
    0
    0
        Follow-up 2 - CS
    0
    0
    0
        Follow-up 2 - ND/Miss
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Clinical chemistry - Aspartate aminotransferase

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    End point title
    		 Clinical chemistry - Aspartate aminotransferase
    End point description
    End point type
    Secondary
    End point timeframe
    At baseline and Follow-up visit 2 (day 19).
    End point values
    		 Group 1 - Experimental Treatment Group 2 - Plerixafor control Group 3 - NaCl placebo control
    Number of subjects analysed
    3
    4
    4
    Units: subjects
        Baseline - Normal
    3
    4
    3
        Baseline - NCS
    0
    0
    1
        Baseline - CS
    0
    0
    0
        Baseline ND/Miss
    0
    0
    0
        Follow-up 2 - Normal
    3
    4
    4
        Follow-up 2 - NCS
    0
    0
    0
        Follow-up 2 - CS
    0
    0
    0
        Follow-up 2 - ND/Miss
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Clinical chemistry - bilirubin

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    End point title
    		 Clinical chemistry - bilirubin
    End point description
    End point type
    Secondary
    End point timeframe
    At baseline and Follow-up visit 2 (day 19).
    End point values
    		 Group 1 - Experimental Treatment Group 2 - Plerixafor control Group 3 - NaCl placebo control
    Number of subjects analysed
    3
    4
    4
    Units: subjects
        Baseline - Normal
    3
    4
    4
        Baseline - NCS
    0
    0
    0
        Baseline - CS
    0
    0
    0
        Baseline - ND/Miss
    0
    0
    0
        Follow-up 2 - Normal
    3
    4
    4
        Follow-up 2 - NCS
    0
    0
    0
        Follow-up 2 - CS
    0
    0
    0
        Follow-up 2 - ND/Miss
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Clinical chemistry - calcium

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    End point title
    		 Clinical chemistry - calcium
    End point description
    End point type
    Secondary
    End point timeframe
    At baseline and Follow-up visit 2 (day 19).
    End point values
    		 Group 1 - Experimental Treatment Group 2 - Plerixafor control Group 3 - NaCl placebo control
    Number of subjects analysed
    3
    4
    4
    Units: subjects
        Baseline - Normal
    3
    4
    3
        Baseline - NCS
    0
    0
    1
        Baseline - CS
    0
    0
    0
        Baseline - ND/Miss
    0
    0
    0
        Follow-up 2 - Normal
    3
    4
    4
        Follow-up 2 - NCS
    0
    0
    0
        Follow-up 2 - CS
    0
    0
    0
        Follow-up 2 ND/Miss
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Clinical chemistry - chloride

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    End point title
    		 Clinical chemistry - chloride
    End point description
    End point type
    Secondary
    End point timeframe
    At baseline and Follow-up visit 2 (day 19).
    End point values
    		 Group 1 - Experimental Treatment Group 2 - Plerixafor control Group 3 - NaCl placebo control
    Number of subjects analysed
    3
    4
    4
    Units: subjects
        Baseline - Normal
    3
    4
    4
        Baseline - NCS
    0
    0
    0
        Baseline - CS
    0
    0
    0
        Baseline - ND/Miss
    0
    0
    0
        Follow-up 2 - Normal
    2
    3
    3
        Follow-up 2 - NCS
    1
    1
    1
        Follow-up 2 - CS
    0
    0
    0
        Follow-up 2 - ND/Miss
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Clinical chemistry - creatinine

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    End point title
    		 Clinical chemistry - creatinine
    End point description
    End point type
    Secondary
    End point timeframe
    At baseline and Follow-up visit 2 (day 19).
    End point values
    		 Group 1 - Experimental Treatment Group 2 - Plerixafor control Group 3 - NaCl placebo control
    Number of subjects analysed
    3
    4
    4
    Units: subjects
        Baseline - Normal
    3
    4
    4
        Baseline - NCS
    0
    0
    0
        Baseline - CS
    0
    0
    0
        Baseline - ND/Miss
    0
    0
    0
        Follow-up 2 - Normal
    3
    4
    3
        Follow-up 2 - NCS
    0
    0
    0
        Follow-up 2 - CS
    0
    0
    1
        Follow-up 2 - ND/Miss
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Clinical chemistry - C reactive protein

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    End point title
    		 Clinical chemistry - C reactive protein
    End point description
    End point type
    Secondary
    End point timeframe
    At baseline and Follow-up visit 2 (day 19).
    End point values
    		 Group 1 - Experimental Treatment Group 2 - Plerixafor control Group 3 - NaCl placebo control
    Number of subjects analysed
    3
    4
    4
    Units: patients
        Baseline - Normal
    3
    4
    4
        Baseline - NCS
    0
    0
    0
        Baseline - CS
    0
    0
    0
        Baseline - ND/Miss
    0
    0
    0
        Follow-up 2 - Normal
    3
    3
    3
        Follow-up 2 - NCS
    0
    1
    1
        Follow-up 2 - CS
    0
    0
    0
        Follow-up 2 - ND/Miss
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Clinical chemistry - glucose

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    End point title
    		 Clinical chemistry - glucose
    End point description
    End point type
    Secondary
    End point timeframe
    At baseline and Follow-up visit 2 (day 19).
    End point values
    		 Group 1 - Experimental Treatment Group 2 - Plerixafor control Group 3 - NaCl placebo control
    Number of subjects analysed
    3
    4
    4
    Units: subjects
        Baseline - Normal
    3
    4
    3
        Baseline - NCS
    0
    0
    1
        Baseline - CS
    0
    0
    0
        Baseline - ND/Miss
    0
    0
    0
        Follow-up 2 - Normal
    3
    4
    4
        Follow-up 2 - NCS
    0
    0
    0
        Follow-up 2 - CS
    0
    0
    0
        Follow-up 2 - ND/Miss
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Clinical chemistry - potassium

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    End point title
    		 Clinical chemistry - potassium
    End point description
    End point type
    Secondary
    End point timeframe
    At baseline and Follow-up visit 2 (day 19).
    End point values
    		 Group 1 - Experimental Treatment Group 2 - Plerixafor control Group 3 - NaCl placebo control
    Number of subjects analysed
    3
    4
    4
    Units: subjects
        Baseline - Normal
    3
    4
    4
        Baseline - NCS
    0
    0
    0
        Baseline - CS
    0
    0
    0
        Baseline - ND/Miss
    0
    0
    0
        Follow-up 2 - Normal
    3
    4
    4
        Follow-up 2 - NCS
    0
    0
    0
        Follow-up 2 - CS
    0
    0
    0
        Follow-up 2 - ND/Miss
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Clinical chemistry - sodium

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    End point title
    		 Clinical chemistry - sodium
    End point description
    End point type
    Secondary
    End point timeframe
    At baseline and Follow-up visit 2 (day 19).
    End point values
    		 Group 1 - Experimental Treatment Group 2 - Plerixafor control Group 3 - NaCl placebo control
    Number of subjects analysed
    3
    4
    4
    Units: subjects
        Baseline - Normal
    2
    2
    3
        Baseline - NCS
    1
    2
    1
        Baseline - CS
    0
    0
    0
        Baseline - ND/Miss
    0
    0
    0
        Follow-up 2 - Normal
    3
    4
    3
        Follow-up 2 - NCS
    0
    0
    1
        Follow-up 2 - CS
    0
    0
    0
        Follow-up 2 - ND/Miss
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Haematology - Basophils

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    End point title
    		 Haematology - Basophils
    End point description
    End point type
    Secondary
    End point timeframe
    From Screening until Follow-up visit 2.
    End point values
    		 Group 1 - Experimental Treatment Group 2 - Plerixafor control Group 3 - NaCl placebo control
    Number of subjects analysed
    3
    4
    4
    Units: x10^9/L
    arithmetic mean (standard deviation)
        Screening
    0.10 ± 0
    0.10 ± 0
    0.10 ± 0
        Pre-dose (-120 min)
    0.23 ± 0.15
    0.18 ± 0.05
    0.23 ± 0.13
        Pre-dose (-30 min)
    0.20 ± 0.10
    0.10 ± 0
    0.15 ± 0.06
        15 min
    0.10 ± 0
    0.10 ± 0
    0.13 ± 0.05
        30 min
    0.17 ± 0.12
    0.18 ± 0.10
    0.15 ± 0.10
        1 h
    0.13 ± 0.06
    0.18 ± 0.10
    0.13 ± 0.05
        3 h
    0.27 ± 0.06
    0.28 ± 0.29
    0.13 ± 0.05
        6 h
    0.20 ± 0.10
    0.25 ± 0.24
    0.10 ± 0
        9 h
    0.17 ± 0.12
    0.28 ± 0.21
    0.20 ± 0.14
        24 h
    0.13 ± 0.06
    0.18 ± 0.10
    0.23 ± 0.13
        Follow-up 2 (day 19)
    0.10 ± 0
    0.10 ± 0
    0.10 ± 0
    No statistical analyses for this end point

    Secondary: Haematology - eosinophils

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    End point title
    		 Haematology - eosinophils
    End point description
    End point type
    Secondary
    End point timeframe
    From Screening until Follow-up visit 2.
    End point values
    		 Group 1 - Experimental Treatment Group 2 - Plerixafor control Group 3 - NaCl placebo control
    Number of subjects analysed
    3
    4
    4
    Units: x10^9/L
    arithmetic mean (standard deviation)
        Screening
    0.17 ± 0.06
    0.33 ± 0.26
    0.15 ± 0.06
        Pre-dose (-120 min)
    0.60 ± 0.10
    0.70 ± 0.29
    0.90 ± 0.24
        Pre-dose (-30 min)
    0.63 ± 0.23
    0.90 ± 0.34
    0.63 ± 0.10
        15 min
    0.77 ± 0.40
    0.83 ± 0.26
    0.60 ± 0.24
        30 min
    1.13 ± 0.74
    0.70 ± 0.53
    0.70 ± 0.18
        1 h
    1.10 ± 0.70
    0.95 ± 0.44
    0.65 ± 0.31
        3 h
    1.03 ± 0.15
    1.40 ± 0.61
    0.55 ± 0.29
        6 h
    1.23 ± 0.90
    1.55 ± 0.31
    0.55 ± 0.34
        9 h
    1.20 ± 0.30
    2.05 ± 0.54
    0.33 ± 0.21
        24 h
    0.83 ± 0.64
    0.83 ± 0.48
    0.30 ± 0.14
        Follow-up 2 (day 19)
    0.20 ± 0.10
    0.23 ± 0.19
    0.15 ± 0.06
    No statistical analyses for this end point

    Secondary: Haematology - haematocrit

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    End point title
    		 Haematology - haematocrit
    End point description
    End point type
    Secondary
    End point timeframe
    From Screening until Follow-up visit 2.
    End point values
    		 Group 1 - Experimental Treatment Group 2 - Plerixafor control Group 3 - NaCl placebo control
    Number of subjects analysed
    3
    4
    4
    Units: (no unit)
    arithmetic mean (standard deviation)
        Screening
    0.430 ± 0.010
    0.435 ± 0.025
    0.415 ± 0.029
        Day 2
    0.427 ± 0.012
    0.443 ± 0.026
    0.428 ± 0.022
        Day 3
    0.430 ± 0.010
    0.440 ± 0.022
    0.413 ± 0.026
        Day 4
    0.430 ± 0.017
    0.428 ± 0.026
    0.413 ± 0.019
        Day 5 Pre-dose (-120 min)
    0.427 ± 0.012
    0.433 ± 0.033
    0.420 ± 0.022
        Pre-dose (-30 min)
    0.420 ± 0.01
    0.423 ± 0.033
    0.420 ± 0.032
        15 min
    0.427 ± 0.012
    0.425 ± 0.026
    0.413 ± 0.028
        30 min
    0.430 ± 0.010
    0.425 ± 0.031
    0.413 ± 0.028
        1 h
    0.430 ± 0.017
    0.423 ± 0.033
    0.413 ± 0.030
        3 h
    0.430 ± 0.017
    0.428 ± 0.039
    0.415 ± 0.031
        6 h
    0.437 ± 0.012
    0.430 ± 0.038
    0.420 ± 0.022
        9 h
    0.433 ± 0.006
    0.433 ± 0.039
    0.420 ± 0.018
        24 h
    0.430 ± 0.010
    0.438 ± 0.030
    0.437 ± 0.021
        Follow-up 2 (day 19)
    0.370 ± 0.010
    0.398 ± 0.036
    0.375 ± 0.021
    No statistical analyses for this end point

    Secondary: Haematology - haemoglobin

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    End point title
    		 Haematology - haemoglobin
    End point description
    End point type
    Secondary
    End point timeframe
    From Screening until Follow-up visit 2.
    End point values
    		 Group 1 - Experimental Treatment Group 2 - Plerixafor control Group 3 - NaCl placebo control
    Number of subjects analysed
    3
    4
    4
    Units: gram(s)/litre
    arithmetic mean (standard deviation)
        Screening
    150.3 ± 2.1
    152.3 ± 10.4
    145.3 ± 6.9
        Day 2
    147.0 ± 2.0
    151.5 ± 9.9
    146.0 ± 3.6
        Day 3
    148.3 ± 2.1
    150.3 ± 10.2
    141.8 ± 7.5
        Day 4
    147.7 ± 4.7
    147.3 ± 11.3
    139.8 ± 4.6
        Day 5 - Pre-dose (-120 min)
    146.0 ± 3.6
    145.3 ± 14.0
    143.0 ± 4.2
        Pre-dose (-30 min)
    144.7 ± 1.5
    145.3 ± 14.0
    142.3 ± 9.9
        15 min
    144.3 ± 2.3
    144.0 ± 12.5
    140.3 ± 7.9
        30 min
    145.7 ± 1.2
    145.3 ± 13.2
    140.3 ± 8.7
        1 h
    148.0 ± 5.0
    144.5 ± 12.4
    141.5 ± 9.0
        3 h
    148.0 ± 1.7
    146.8 ± 15.8
    141.0 ± 8.0
        6 h
    150.0 ± 3.0
    146.3 ± 13.5
    143.3 ± 8.2
        9 h
    149.7 ± 3.8
    149.5 ± 14.9
    144.0 ± 7.1
        24 h
    146.7 ± 2.9
    149.8 ± 9.3
    148.7 ± 5.5
        Follow-up 2 (day 19)
    130.0 ± 3.5
    139.5 ± 12.8
    130.3 ± 8.2
    No statistical analyses for this end point

    Secondary: Haematology - monocytes

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    End point title
    		 Haematology - monocytes
    End point description
    End point type
    Secondary
    End point timeframe
    From Screening until Follow-up visit 2.
    End point values
    		 Group 1 - Experimental Treatment Group 2 - Plerixafor control Group 3 - NaCl placebo control
    Number of subjects analysed
    3
    4
    4
    Units: x10^9/L
    arithmetic mean (standard deviation)
        Screening
    0.50 ± 0.10
    0.78 ± 0.13
    0.48 ± 0.05
        Pre-dose (-120 min)
    1.73 ± 0.60
    3.25 ± 0.70
    2.30 ± 0.67
        Pre-dose (-30 min)
    1.43 ± 0.60
    1.38 ± 0.56
    0.93 ± 0.22
        15 min
    2.53 ± 0.67
    2.43 ± 0.98
    1.30 ± 0.67
        30 min
    1.63 ± 0.75
    2.80 ± 1.03
    1.73 ± 0.39
        1 h
    1.80 ± 0.17
    3.00 ± 1.12
    1.45 ± 0.26
        3 h
    2.13 ± 0.64
    4.68 ± 2.26
    1.40 ± 0.23
        6 h
    3.10 ± 1.57
    5.63 ± 3.01
    2.72 ± 0.59
        9 h
    2.77 ± 1.96
    4.98 ± 1.02
    2.75 ± 1.23
        24 h
    1.50 ± 1.15
    4.60 ± 1.54
    2.00 ± 1.05
        Follow-up 2 (day 19)
    0.37 ± 0.12
    0.55 ± 0.24
    0.40 ± 0.08
    No statistical analyses for this end point

    Secondary: Haematology - neutrophils

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    End point title
    		 Haematology - neutrophils
    End point description
    End point type
    Secondary
    End point timeframe
    From Screening until Follow-up visit 2.
    End point values
    		 Group 1 - Experimental Treatment Group 2 - Plerixafor control Group 3 - NaCl placebo control
    Number of subjects analysed
    3
    4
    4
    Units: x10^9/L
    arithmetic mean (standard deviation)
        Screening
    3.93 ± 0.51
    4.03 ± 0.92
    3.40 ± 1.27
        Pre-dose (-120 min)
    32.83 ± 0.76
    28.35 ± 5.63
    25.80 ± 8.92
        Pre-dose (-30 min)
    18.30 ± 6.67
    12.70 ± 4.31
    8.08 ± 4.83
        15 min
    23.17 ± 1.95
    19.10 ± 3.88
    12.80 ± 5.70
        30 min
    26.93 ± 1.66
    22.88 ± 4.50
    13.28 ± 5.51
        1 h
    30.93 ± 2.86
    24.35 ± 6.28
    15.88 ± 5.19
        3 h
    42.93 ± 2.59
    35.15 ± 8.33
    23.85 ± 6.88
        6 h
    50.93 ± 1.66
    42.85 ± 7.40
    30.58 ± 9.41
        9 h
    51.47 ± 5.93
    47.35 ± 9.34
    34.10 ± 10.53
        24 h
    39.23 ± 6.78
    43.38 ± 10.43
    26.28 ± 7.74
        Follow-up 2 (day 19)
    2.17 ± 0.74
    2.63 ± 0.74
    1.73 ± 0.78
    No statistical analyses for this end point

    Secondary: Haematology - platelets

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    End point title
    		 Haematology - platelets
    End point description
    End point type
    Secondary
    End point timeframe
    From Screening until Follow-up visit 2.
    End point values
    		 Group 1 - Experimental Treatment Group 2 - Plerixafor control Group 3 - NaCl placebo control
    Number of subjects analysed
    3
    4
    4
    Units: x10^9/L
    arithmetic mean (standard deviation)
        Screening
    213.0 ± 24.6
    260.0 ± 26.0
    194.3 ± 27.0
        Day 2
    190.3 ± 34.7
    246.0 ± 31.4
    191.0 ± 38.9
        Day 3
    192.0 ± 37.0
    237.5 ± 27.4
    180.8 ± 26.7
        Day 4
    189.0 ± 33.0
    223.8 ± 43.1
    176.3 ± 22.1
        Day 5 - Pre-dose (-120 min)
    171.0 ± 25.1
    221.8 ± 37.6
    175.8 ± 17.7
        Pre-dose (-30 min)
    165.3 ± 24.9
    207.5 ± 34.7
    162.3 ± 19.4
        15 min
    182.7 ± 35.5
    215.3 ± 28.8
    168.3 ± 15.9
        30 min
    185.3 ± 37.1
    219.0 ± 32.8
    165.3 ± 21.8
        1 h
    181.0 ± 29.1
    207.8 ± 31.1
    165.5 ± 24.5
        3 h
    175.3 ± 25.5
    211.0 ± 33.3
    165.5 ± 13.5
        6 h
    187.0 ± 27.6
    229.8 ± 39.4
    174.3 ± 20.4
        9 h
    175.7 ± 22.1
    222.3 ± 31.4
    173.5 ± 15.5
        24 h
    142.3 ± 11.6
    217.0 ± 34.8
    166.7 ± 24.2
        Follow-up 2 (day 19)
    273.0 ± 5.2
    268.5 ± 77.0
    240.8 ± 85.9
    No statistical analyses for this end point

    Secondary: Haematology - erythrocytes

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    End point title
    		 Haematology - erythrocytes
    End point description
    End point type
    Secondary
    End point timeframe
    From Screening until Follow-up visit 2.
    End point values
    		 Group 1 - Experimental Treatment Group 2 - Plerixafor control Group 3 - NaCl placebo control
    Number of subjects analysed
    3
    4
    4
    Units: x10^12/L
    arithmetic mean (standard deviation)
        Screening
    5.10 ± 0
    5.10 ± 0.43
    4.80 ± 0.34
        Day 2
    4.93 ± 0.06
    5.08 ± 0.44
    4.90 ± 0.22
        Day 3
    5.00 ± 0.10
    5.00 ± 0.42
    4.73 ± 0.30
        Day 4
    4.97 ± 0.12
    4.88 ± 0.50
    4.68 ± 0.25
        Day 5 - Pre-dose (-120 min)
    4.90 ± 0.10
    4.90 ± 0.54
    4.78 ± 0.21
        Pre-dose (-30 min)
    4.87 ± 0.06
    4.83 ± 0.50
    4.78 ± 0.40
        15 min
    4.87 ± 0.06
    4.88 ± 0.51
    4.68 ± 0.34
        30 min
    4.93 ± 0.12
    4.85 ± 0.55
    4.70 ± 0.36
        1 h
    4.93 ± 0.12
    4.83 ± 0.57
    4.70 ± 0.34
        3 h
    4.93 ± 0.06
    4.90 ± 0.61
    4.73 ± 0.36
        6 h
    4.97 ± 0.06
    4.93 ± 0.56
    4.73 ± 0.29
        9 h
    4.93 ± 0.06
    4.93 ± 0.59
    4.78 ± 0.26
        24 h
    4.93 ± 0.06
    5.03 ± 0.46
    5.00 ± 0
        Follow-up 2 (day 19)
    4.40 ± 0.10
    4.68 ± 0.52
    4.35 ± 0.31
    No statistical analyses for this end point

    Secondary: White blood cells / leukocytes

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    End point title
    		 White blood cells / leukocytes
    End point description
    End point type
    Secondary
    End point timeframe
    From Screening until Follow-up visit 2.
    End point values
    		 Group 1 - Experimental Treatment Group 2 - Plerixafor control Group 3 - NaCl placebo control
    Number of subjects analysed
    3
    4
    4
    Units: x10^9/L
    arithmetic mean (standard deviation)
        Screening
    7.03 ± 0.71
    7.33 ± 0.94
    5.43 ± 1.09
        Day 2
    28.90 ± 2.36
    30.25 ± 2.89
    25.28 ± 8.39
        Day 3
    34.90 ± 4.43
    32.05 ± 3.14
    27.00 ± 8.72
        Day 4
    38.17 ± 4.32
    37.05 ± 7.55
    30.80 ± 9.85
        Day 5 - Pre-dose (-120 min)
    41.90 ± 2.97
    37.53 ± 7.20
    33.08 ± 9.24
        Pre-dose (-30 min)
    25.70 ± 9.09
    19.65 ± 4.98
    12.78 ± 4.34
        15 min
    34.30 ± 4.13
    30.30 ± 4.97
    19.23 ± 5.85
        30 min
    38.50 ± 4.31
    34.18 ± 4.35
    20.25 ± 6.40
        1 h
    44.47 ± 4.97
    37.15 ± 5.96
    21.78 ± 5.21
        3 h
    57.53 ± 6.26
    51.08 ± 9.35
    29.58 ± 7.65
        6 h
    65.87 ± 3.93
    63.33 ± 12.47
    38.48 ± 10.50
        9 h
    64.73 ± 3.19
    65.85 ± 11.70
    42.48 ± 9.42
        24 h
    49.90 ± 10.58
    57.05 ± 12.90
    33.08 ± 5.31
        Follow-up 2 (day 19)
    4.47 ± 1.11
    4.98 ± 0.97
    3.38 ± 0.94
    No statistical analyses for this end point

    Secondary: APTT

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    End point title
    		 APTT [2]
    End point description
    End point type
    Secondary
    End point timeframe
    From Screening until 24 hours after dose (Group 1)
    Notes
    [2] - 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: The study drug administered in Group 1 (Experimental Arm, LMW-DS) has a specific property of prolonging the APTT significantly, which the drugs in the control Arms (Group 2, Group 3) do not have, which is why the APTT parameter was relevant to study only for Group 1.
    End point values
    		 Group 1 - Experimental Treatment
    Number of subjects analysed
    3
    Units: second
    arithmetic mean (standard deviation)
        Screening
    33.7 ± 0.6
        Pre-dose (-30 min)
    30.7 ± 0.6
        6 h
    104.0 ± 11.4
        9 h
    73.7 ± 5.7
        24 h
    38.7 ± 2.1
    No statistical analyses for this end point

    Secondary: Systolic blood pressure

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    End point title
    		 Systolic blood pressure
    End point description
    End point type
    Secondary
    End point timeframe
    From Screening until Follow-up visit 2.
    End point values
    		 Group 1 - Experimental Treatment Group 2 - Plerixafor control Group 3 - NaCl placebo control
    Number of subjects analysed
    3
    4
    4
    Units: mmHg
    arithmetic mean (standard deviation)
        Screening
    127.3 ± 4.6
    131.8 ± 6.7
    134.5 ± 5.2
        Pre-dose (-30 min)
    118.3 ± 8.7
    126.3 ± 1.5
    123.8 ± 11.9
        15 min
    121.7 ± 6.5
    126.8 ± 5.5
    127.5 ± 3.9
        30 min
    126.0 ± 3.0
    123.8 ± 3.5
    117.3 ± 6.6
        1 h
    129.3 ± 4.2
    125.0 ± 8.5
    125.5 ± 12.1
        2 h
    125.3 ± 7.2
    123.5 ± 4.5
    126.3 ± 10.9
        3 h
    125.0 ± 7.2
    134.8 ± 5.1
    131.0 ± 12.9
        4 h
    127.0 ± 5.3
    128.3 ± 5.9
    126.0 ± 5.0
        5 h
    124.7 ± 14.5
    126.0 ± 9.3
    125.3 ± 5.1
        6 h
    131.5 ± 0.7
    123.5 ± 9.5
    125.3 ± 6.8
        7 h
    127.7 ± 4.2
    127.5 ± 7.2
    129.0 ± 11.2
        8 h
    130.7 ± 1.2
    131.3 ± 11.0
    127.5 ± 3.9
        Follow-up 2 (day 19)
    124.7 ± 5.1
    128.5 ± 4.2
    130.3 ± 7.4
    No statistical analyses for this end point

    Secondary: Diastolic blood pressure

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    End point title
    		 Diastolic blood pressure
    End point description
    End point type
    Secondary
    End point timeframe
    From Screening until Follow-up visit 2.
    End point values
    		 Group 1 - Experimental Treatment Group 2 - Plerixafor control Group 3 - NaCl placebo control
    Number of subjects analysed
    3
    4
    4
    Units: mmHg
    arithmetic mean (standard deviation)
        Screening
    73.0 ± 5.0
    81.3 ± 3.3
    76.0 ± 4.3
        Pre-dose (-30 min)
    72.0 ± 5.0
    77.5 ± 3.9
    73.5 ± 7.9
        15 min
    72.7 ± 5.9
    77.0 ± 3.6
    72.8 ± 1.9
        30 min
    75.3 ± 8.1
    74.3 ± 4.9
    70.8 ± 5.1
        1 h
    74.0 ± 7.5
    73.0 ± 6.4
    75.0 ± 9.1
        2 h
    72.3 ± 5.0
    75.0 ± 5.9
    71.8 ± 8.2
        3 h
    74.3 ± 7.6
    73.0 ± 10.6
    71.8 ± 7.6
        4 h
    70.0 ± 5.3
    73.8 ± 7.4
    69.0 ± 2.9
        5 h
    73.3 ± 9.9
    75.5 ± 5.6
    73.8 ± 2.8
        6 h
    78.5 ± 2.1
    72.0 ± 5.0
    73.3 ± 7.5
        7 h
    77.0 ± 4.0
    77.0 ± 7.1
    76.8 ± 5.6
        8 h
    78.0 ± 7.9
    77.0 ± 4.2
    73.8 ± 4.5
        Follow-up 2 (day 19)
    73.0 ± 10.1
    78.5 ± 5.3
    72.5 ± 4.5
    No statistical analyses for this end point

    Secondary: Pulse rate

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    End point title
    		 Pulse rate
    End point description
    End point type
    Secondary
    End point timeframe
    From Screening until Follow-up visit 2.
    End point values
    		 Group 1 - Experimental Treatment Group 2 - Plerixafor control Group 3 - NaCl placebo control
    Number of subjects analysed
    3
    4
    4
    Units: bpm
    arithmetic mean (standard deviation)
        Screening
    51.7 ± 5.5
    55.0 ± 7.5
    60.5 ± 2.6
        Pre-dose (-30 min)
    55.3 ± 7.2
    57.3 ± 13.0
    56.0 ± 4.7
        15 min
    60.7 ± 11.5
    58.0 ± 13.7
    52.5 ± 2.6
        30 min
    57.0 ± 7.5
    55.8 ± 12.7
    53.5 ± 6.0
        1 h
    59.7 ± 3.5
    57.3 ± 16.0
    56.8 ± 12.3
        2 h
    62.3 ± 11.0
    59.3 ± 14.7
    61.5 ± 11.4
        3 h
    71.7 ± 8.1
    68.5 ± 20.8
    67.5 ± 4.7
        4 h
    67.0 ± 3.5
    64.5 ± 18.6
    64.5 ± 6.6
        5 h
    67.0 ± 11.3
    69.0 ± 18.5
    63.3 ± 9.0
        6 h
    63.3 ± 3.2
    69.5 ± 20.6
    62.0 ± 10.0
        7 h
    70.0 ± 12.2
    64.8 ± 19.1
    65.3 ± 6.7
        8 h
    62.3 ± 6.7
    65.3 ± 16.0
    65.5 ± 11.4
        Follow-up 2 (day 19)
    56.7 ± 8.4
    66.0 ± 8.7
    66.5 ± 3.5
    No statistical analyses for this end point

    Secondary: Tympanic body temperature

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    End point title
    		 Tympanic body temperature
    End point description
    End point type
    Secondary
    End point timeframe
    From Screening until Follow-up visit 2.
    End point values
    		 Group 1 - Experimental Treatment Group 2 - Plerixafor control Group 3 - NaCl placebo control
    Number of subjects analysed
    3
    4
    4
    Units: celsius temperature
    arithmetic mean (standard deviation)
        Screening
    36.30 ± 0.20
    36.28 ± 0.31
    36.83 ± 0.47
        Pre-dose (-30 min)
    36.43 ± 0.49
    36.60 ± 0.14
    36.68 ± 0.55
        15 min
    36.43 ± 0.50
    36.55 ± 0.30
    36.65 ± 0.29
        30 min
    36.47 ± 0.32
    36.63 ± 0.37
    36.53 ± 0.46
        1 h
    36.47 ± 0.23
    36.43 ± 0.34
    36.60 ± 0.24
        2 h
    36.63 ± 0.31
    36.78 ± 0.37
    36.70 ± 0.55
        3 h
    36.93 ± 0.21
    37.03 ± 0.33
    36.78 ± 0.21
        4 h
    37.13 ± 0.32
    36.80 ± 0.08
    36.93 ± 0.36
        5 h
    36.93 ± 0.40
    36.63 ± 0.73
    37.05 ± 0.53
        6 h
    36.97 ± 0.29
    37.08 ± 0.22
    37.08 ± 0.33
        7 h
    36.90 ± 0.50
    36.95 ± 0.52
    37.03 ± 0.36
        8 h
    36.87 ± 0.35
    37.13 ± 0.15
    37.05 ± 0.17
        Follow-up 2 (day 19)
    36.33 ± 0.12
    36.50 ± 0.32
    36.48 ± 0.29
    No statistical analyses for this end point

    Secondary: ECG

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    End point title
    		 ECG
    End point description
    End point type
    Secondary
    End point timeframe
    At baseline and Follow-up visit 2 (day 19).
    End point values
    		 Group 1 - Experimental Treatment Group 2 - Plerixafor control Group 3 - NaCl placebo control
    Number of subjects analysed
    3
    4
    4
    Units: subjects
        Baseline - Normal
    2
    4
    4
        Baseline - NCS
    1
    0
    0
        Baseline - CS
    0
    0
    0
        Follow-up 2 - Normal
    2
    4
    4
        Follow-up 2 - NCS
    1
    0
    0
        Follow-up 2 - CS
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Physical exam

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    End point title
    		 Physical exam
    End point description
    End point type
    Secondary
    End point timeframe
    At baseline and Follow-up visit 2 (day 19).
    End point values
    		 Group 1 - Experimental Treatment Group 2 - Plerixafor control Group 3 - NaCl placebo control
    Number of subjects analysed
    3
    4
    4
    Units: subjects
        Baseline - Normal
    2
    2
    2
        Baseline - NCS
    1
    2
    2
        Baseline - CS
    0
    0
    0
        Follow-up 2 - Normal
    3
    3
    4
        Follow-up 2 - NCS
    0
    0
    0
        Follow-up 2 - CS
    0
    1
    0
    No statistical analyses for this end point

    Secondary: Clinical Chemistry - creatinine kinase

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    End point title
    		 Clinical Chemistry - creatinine kinase
    End point description
    End point type
    Secondary
    End point timeframe
    At baseline and Follow-up visit 2 (day 19).
    End point values
    		 Group 1 - Experimental Treatment Group 2 - Plerixafor control Group 3 - NaCl placebo control
    Number of subjects analysed
    3
    4
    4
    Units: subjects
        Baseline - Normal
    2
    4
    4
        Baseline - NCS
    1
    0
    0
        Baseline - CS
    0
    0
    0
        Baseline - ND/Miss
    0
    0
    0
        Follow-up 2 - Normal
    3
    4
    4
        Follow-up 2 - NCS
    0
    0
    0
        Follow-up 2 - CS
    0
    0
    0
        Follow-up 2 - ND/Miss
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Spirometry - FEV1, FVC, PEF, VC

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    End point title
    		 Spirometry - FEV1, FVC, PEF, VC
    End point description
    FEV1 = Forced Expiratory Volume in 1 Second (L) FVC = Forced Vital Capacity (L) PEF = Peak Expiratory Flow (L) VC = Vital Capacity (L)
    End point type
    Secondary
    End point timeframe
    At baseline and Follow-up visit 2 (day 19).
    End point values
    		 Group 1 - Experimental Treatment Group 2 - Plerixafor control Group 3 - NaCl placebo control
    Number of subjects analysed
    3
    4
    4
    Units: subjects
        Baseline FEV1 - Normal
    2
    4
    4
        Baseline FEV1 - NCS
    1
    0
    0
        Baseline FEV1 - CS
    0
    0
    0
        Baseline FVC - Normal
    3
    3
    4
        Baseline FVC - NCS
    0
    1
    0
        Baseline FVC - CS
    0
    0
    0
        Baseline PEF - Normal
    2
    4
    4
        Baseline PEF - NCS
    1
    0
    0
        Baseline PEF - CS
    0
    0
    0
        Baseline VC - Normal
    2
    3
    4
        Baseline VC - NCS
    1
    1
    0
        Baseline VC - CS
    0
    0
    0
        Follow-up 2 FEV1 - Normal
    2
    4
    4
        Follow-up 2 FEV1 - NCS
    1
    0
    0
        Follow-up 2 FEV1 - CS
    0
    0
    0
        Follow-up 2 FVC - Normal
    3
    3
    4
        Follow-up 2 FVC -NCS
    0
    1
    0
        Follow-up 2 FVC - CS
    0
    0
    0
        Follow-up 2 PEF - Normal
    3
    3
    3
        Follow-up 2 PEF - NCS
    0
    1
    1
        Follow-up 2 PEF - CS
    0
    0
    0
        Follow-up 2 VC - Normal
    2
    1
    4
        Follow-up 2 VC - NCS
    1
    3
    0
        Follow-up 2 VC - CS
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Spirometry - PP FEV1/FVC

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    End point title
    		 Spirometry - PP FEV1/FVC
    End point description
    Percent Predicted Forced Expiratory Volume in 1 Second / Forced Vital Capacity (%)
    End point type
    Secondary
    End point timeframe
    At baseline and Follow-up visit 2 (day 19).
    End point values
    		 Group 1 - Experimental Treatment Group 2 - Plerixafor control Group 3 - NaCl placebo control
    Number of subjects analysed
    3
    4
    4
    Units: percent
    arithmetic mean (standard deviation)
        Baseline
    78.64 ± 9.39
    76.66 ± 5.98
    75.85 ± 5.53
        Follow-up 2
    77.69 ± 8.64
    74.17 ± 4.79
    75.89 ± 7.58
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    After administration of LMW-DS/Plerixafor/NaCl
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.0
    Reporting groups
    Reporting group title
    Group 1 - Experimental Treatment
    Reporting group description
    		 LMW-DS + Filgrastim

    Reporting group title
    Group 2 - Plerixafor control
    Reporting group description
    		 Plerixafor + Filgrastim

    Reporting group title
    Group 3 - NaCl placebo control
    Reporting group description
    		 NaCl + Filgrastim

    Serious adverse events
    		 Group 1 - Experimental Treatment Group 2 - Plerixafor control Group 3 - NaCl placebo control
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Group 1 - Experimental Treatment Group 2 - Plerixafor control Group 3 - NaCl placebo control
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 3 (100.00%)
    4 / 4 (100.00%)
    4 / 4 (100.00%)
    Investigations
    Activated partial thromboplastin time prolonged
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    Vascular disorders
    Hot flush
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    2 / 3 (66.67%)
    1 / 4 (25.00%)
    1 / 4 (25.00%)
         occurrences all number
    2
    1
    1
    Dizziness
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    Hypoaesthesia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    1
    Blood and lymphatic system disorders
    Leukopenia
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    3 / 4 (75.00%)
         occurrences all number
    1
    0
    3
    Neutropenia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    2 / 4 (50.00%)
         occurrences all number
    0
    0
    2
    Thrombocytopenia
         subjects affected / exposed
    0 / 3 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    0
    1
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    2
    0
    Feeling hot
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    Influenza like illness
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 3 (0.00%)
    2 / 4 (50.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    2
    0
    Abdominal tenderness
         subjects affected / exposed
    1 / 3 (33.33%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Dyspepsia
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    Flatulence
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    Hypoaesthesia oral
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 3 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    Skin and subcutaneous tissue disorders
    Hyperhidrosis
         subjects affected / exposed
    1 / 3 (33.33%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    1
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    1 / 3 (33.33%)
    1 / 4 (25.00%)
    1 / 4 (25.00%)
         occurrences all number
    1
    1
    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? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    The study was terminated early due to lack of effect on the primary endpoint, mobilization of CD34+ cells, in the experimental group. Only 3 subjects received the experimental treatment and the statistical analysis was not as extensive as planned.
    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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