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    Clinical Trial Results:
    A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C) in Symptomatic Subjects with Generalized Myasthenia Gravis

    Summary
    EudraCT number
    		 2014-003997-18
    Trial protocol
    		 LT   EE   HU   CZ   DE   BE  
    Global end of trial date
    26 Jan 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    08 Feb 2019
    First version publication date
    08 Feb 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GTI1408
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02473952
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Grifols Therapeutics LLC
    Sponsor organisation address
    79 TW Alexander Drive, Research Triangle Park, North Carolina, United States, NC 27709
    Public contact
    Rhonda Griffin, Grifols Therapeutics LLC, rhonda.griffin@grifols.com
    Scientific contact
    Rhonda Griffin, Grifols Therapeutics LLC, rhonda.griffin@grifols.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
    26 Jan 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Jan 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C) in subjects with generalized myasthenia gravis (MG) on standard of care treatment at study entry in terms of improvement in MG symptoms as measured by the mean change in Quantitative Myasthenia Gravis (QMG) total score from baseline (Week 0) to Week 24 as compared to placebo.
    Protection of trial subjects
    Standards for Good Clinical Practice were adhered to for all procedures in this clinical study. The investigators ensured that the clinical study was conducted in full conformance with appropriate local laws and regulations and the Declaration of Helsinki.
    Background therapy
    		 Standard of care treatment for MG included cholinesterase inhibitors, corticosteroid (CS) as an immunosuppressant/immunomodulator alone or in combination with other MG medications, any non-CS immunosuppressant/immunomodulator alone or in combination with other MG medications.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    14 Aug 2015
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 15
    Country: Number of subjects enrolled
    Canada: 8
    Country: Number of subjects enrolled
    Czech Republic: 9
    Country: Number of subjects enrolled
    Germany: 3
    Country: Number of subjects enrolled
    Hungary: 6
    Country: Number of subjects enrolled
    Poland: 15
    Country: Number of subjects enrolled
    Estonia: 2
    Country: Number of subjects enrolled
    Lithuania: 4
    Worldwide total number of subjects
    62
    EEA total number of subjects
    39
    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)
    49
    From 65 to 84 years
    13
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Sixty two subjects with MG who were symptomatic on standard of care treatment with a QMG total score of at least 10 at screening were enrolled from August 2015 to January 2018 in this multicenter study.

    Pre-assignment
    Screening details
    		 Randomization was stratified according to baseline standard of care MG treatment at time of randomization: Cholinesterase inhibitors only; CS alone or with other MG medications and any non-CS immunosuppressant/immunomodulator alone or with other MG medications which may include CS.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer
    Blinding implementation details
    To maintain blinding, the unblinded pharmacist or designee prepared all investigational product (IP) infusion bags with no visual differences between IGIV-C and placebo, which included covering the IP infusion with a non-transparent blinding bag cover. Results of the central laboratory analysis of immunoglobulin G (IgG) levels were not shared with the investigator, or other blinded study staff involved with study conduct.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 IGIV-C
    Arm description
    		 Subjects were randomized to receive IGIV-C. An initial loading dose of 2 grams per kilogram (g/kg) of body weight was administered after completing baseline assessments at the Baseline Visit (Week 0, Visit 1). Seven subsequent maintenance doses of 1 g/kg of body weight were administered every third week from Week 3 (Visit 2) to Week 21 (Visit 8).
    Arm type
    		 Experimental

    Investigational medicinal product name
    IGIV-C
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    IGIV-C was administered as intravenous infusions with a limit of no more than 80 g/day, corresponding to body weight of 80 kg for a 1 g/kg per diem dosage. The loading dose of 2 g/kg was administered as divided doses over 2 consecutive days with an extension of up to 4 days to account for tolerability/weight in subjects weighing >80 kg. Maintenance doses of 1 g/kg were administered in 1 day with extension to 2 consecutive days to account for tolerability/weight in subjects weighing >80 kg.

    Arm title
    		 Placebo
    Arm description
    		 Subjects were randomized to receive placebo. An initial loading dose using the same volume as would be required for the IGIV-C loading dose was administered after completing baseline assessments at the Baseline Visit (Week 0, Visit 1). Seven subsequent placebo maintenance doses were matched in volume to the IGIV-C maintenance doses, administered every third week from Week 3 (Visit 2) to Week 21 (Visit 8).
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Placebo consisting of sterile 0.9% sodium chloride was administered as intravenous infusion in a volume approximate to that required for the appropriate weight-based dose of IGIV-C.

    Number of subjects in period 1
    		IGIV-C Placebo
    Started
    30
    32
    Completed
    28
    24
    Not completed
    2
    8
         Consent withdrawn by subject
    -
    6
         Adverse event, non-fatal
    2
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    IGIV-C
    Reporting group description
    		 Subjects were randomized to receive IGIV-C. An initial loading dose of 2 grams per kilogram (g/kg) of body weight was administered after completing baseline assessments at the Baseline Visit (Week 0, Visit 1). Seven subsequent maintenance doses of 1 g/kg of body weight were administered every third week from Week 3 (Visit 2) to Week 21 (Visit 8).

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects were randomized to receive placebo. An initial loading dose using the same volume as would be required for the IGIV-C loading dose was administered after completing baseline assessments at the Baseline Visit (Week 0, Visit 1). Seven subsequent placebo maintenance doses were matched in volume to the IGIV-C maintenance doses, administered every third week from Week 3 (Visit 2) to Week 21 (Visit 8).

    Reporting group values
    		 IGIV-C Placebo Total
    Number of subjects
    		 30 32
    Age categorical
    Units: Subjects
    Age continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 54.6 ± 17.06 48.0 ± 13.66 -
    Gender categorical
    Units: Subjects
        Female
    		 14 19 33
        Male
    		 16 13 29
    Standard of Care MG Treatment Regimen at Randomization
    Units: Subjects
        Only Cholinesterase Inhibitors
    		 8 10 18
        CS as Only Immunosuppressant/Immunomodulator
    		 6 4 10
        Any Non-CS Immunosuppressant/Immunomodulator
    		 16 18 34

    End points

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    End points reporting groups
    Reporting group title
    IGIV-C
    Reporting group description
    		 Subjects were randomized to receive IGIV-C. An initial loading dose of 2 grams per kilogram (g/kg) of body weight was administered after completing baseline assessments at the Baseline Visit (Week 0, Visit 1). Seven subsequent maintenance doses of 1 g/kg of body weight were administered every third week from Week 3 (Visit 2) to Week 21 (Visit 8).

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects were randomized to receive placebo. An initial loading dose using the same volume as would be required for the IGIV-C loading dose was administered after completing baseline assessments at the Baseline Visit (Week 0, Visit 1). Seven subsequent placebo maintenance doses were matched in volume to the IGIV-C maintenance doses, administered every third week from Week 3 (Visit 2) to Week 21 (Visit 8).

    Primary: Mean Change in QMG Total Score from Baseline to Week 24

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    End point title
    		 Mean Change in QMG Total Score from Baseline to Week 24
    End point description
    The efficacy of IGIV-C was evaluated in subjects with MG through the assessment of change from baseline (Week 0) to Week 24 in the QMG total score. The QMG consists of 13 test items, each graded according to level of symptoms with none=0, mild=1, moderate=2 or severe=3. The scores for each individual item are added together for the total score, ranging from 0 (least severe symptoms) to 39 (most severe symptoms). Data is presented for the last observation carried forward (LOCF) in the modified intent-to-treat (mITT) population. Baseline was defined as the last non-missing measurement taken prior to first dose of IP.
    End point type
    Primary
    End point timeframe
    Baseline (Week 0) to Week 24.
    End point values
    		 IGIV-C Placebo
    Number of subjects analysed
    30
    32
    Units: Units on a scale
        arithmetic mean (standard deviation)
    -4.6 ± 5.11
    -2.7 ± 6.23
    Statistical analysis title
    		 Treatment difference (IGIV-C - Placebo)
    Statistical analysis description
    The analysis of covariance (ANCOVA) model included change from baseline in QMG total score as the dependent variable, with treatment and baseline standard of care treatment regimen as fixed factors, and baseline QMG total score as a covariate.
    Comparison groups
    IGIV-C v Placebo
    Number of subjects included in analysis
    62
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.187
    Method
    		 ANCOVA
    Parameter type
    		 Least squares mean treatment difference
    Point estimate
    -2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5
         upper limit
    		 1

    Secondary: Percentage of Subjects who Experienced a Clinical Improvement Assessed by QMG Total Score from Baseline to Week 24

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    End point title
    		 Percentage of Subjects who Experienced a Clinical Improvement Assessed by QMG Total Score from Baseline to Week 24
    End point description
    The percentage of subjects who experienced a clinical improvement as assessed by change in QMG total score from baseline (Week 0) to Week 24, where clinical improvement was defined as at least a 3-point decrease in QMG total score, is presented. Data is presented for the LOCF in the mITT population. Baseline was defined as the last non-missing measurement taken prior to first dose of IP.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0) to Week 24.
    End point values
    		 IGIV-C Placebo
    Number of subjects analysed
    30
    32
    Units: Percentage of subjects
        number (not applicable)
    70.0
    59.4
    Statistical analysis title
    		 IGIV-C versus Placebo
    Statistical analysis description
    The ratio of the proportion of subjects experiencing a clinical improvement in the 2 treatment groups (IGIV-C relative to Placebo) is presented.
    Comparison groups
    IGIV-C v Placebo
    Number of subjects included in analysis
    62
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.442 [1]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    1.159
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.798
         upper limit
    		 1.683
    Notes
    [1] - The Cochran-Mantel-Haenszel test was adjusted for baseline standard of care treatment regimen.

    Secondary: Percentage of Subjects who Experienced a Clinical Improvement Assessed by the MG Composite Scale from Baseline to Week 24

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    End point title
    		 Percentage of Subjects who Experienced a Clinical Improvement Assessed by the MG Composite Scale from Baseline to Week 24
    End point description
    The percentage of subjects who experienced a clinical improvement as assessed by change in MG Composite score from baseline (Week 0) to Week 24, where clinical improvement was defined as at least a 3-point decrease in MG Composite total score, is presented. The MG Composite scale consists of 10 items, and the total score ranges from 0 to 50, with a higher score indicating more severe symptoms. Data is presented for the LOCF in the mITT population. Baseline was defined as the last non-missing measurement taken prior to first dose of IP.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0) to Week 24.
    End point values
    		 IGIV-C Placebo
    Number of subjects analysed
    30
    32
    Units: Percentage of subjects
        number (not applicable)
    60.0
    53.1
    Statistical analysis title
    		 IGIV-C versus Placebo
    Statistical analysis description
    The ratio of the proportion of subjects who experienced a clinical improvement in the 2 treatment groups (IGIV-C relative to Placebo) is presented.
    Comparison groups
    IGIV-C v Placebo
    Number of subjects included in analysis
    62
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.61 [2]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    1.123
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.73
         upper limit
    		 1.728
    Notes
    [2] - The Cochran-Mantel-Haenszel test was adjusted for baseline standard of care treatment regimen.

    Secondary: Percentage of Subjects who Experienced a Clinical Improvement Assessed by the MG - Activities of Daily Living (MG-ADL) Questionnaire from Baseline to Week 24

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    End point title
    		 Percentage of Subjects who Experienced a Clinical Improvement Assessed by the MG - Activities of Daily Living (MG-ADL) Questionnaire from Baseline to Week 24
    End point description
    The percentage of subjects who experienced a clinical improvement as assessed by change in MG-ADL score from baseline to Week 24, where clinical improvement was defined as at least a 2-point decrease in MG-ADL total score, is presented. The MG-ADL is an 8-item questionnaire, in which each item is graded from 0 to 3, and the total score ranges from 0 to 24, with a higher score indicating more severe symptoms. Data is presented for the LOCF in the mITT population. Baseline was defined as the last non-missing measurement taken prior to first dose of IP.
    End point type
    Secondary
    End point timeframe
    Baseline (Week 0) to Week 24.
    End point values
    		 IGIV-C Placebo
    Number of subjects analysed
    30
    32
    Units: Percentage of subjects
        number (not applicable)
    70.0
    40.6
    Statistical analysis title
    		 IGIV-C versus Placebo
    Statistical analysis description
    The ratio of the proportion of subjects who experienced a clinical improvement in the 2 treatment groups (IGIV-C relative to Placebo) is presented.
    Comparison groups
    IGIV-C v Placebo
    Number of subjects included in analysis
    62
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.025 [3]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    1.701
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.061
         upper limit
    		 2.727
    Notes
    [3] - The Cochran-Mantel-Haenszel test was adjusted for baseline standard of care treatment regimen.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Treatment emergent adverse events were collected, defined as adverse events that started on or after the beginning of the first infusion of IP and prior to the final study visit.
    Adverse event reporting additional description
    The safety population consisted of all randomized subjects who received any amount of IP, and subjects were classified according to treatment received.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Subjects were randomized to receive placebo. An initial loading dose using the same volume as would be required for the IGIV-C loading dose was administered after completing baseline assessments at the Baseline Visit (Week 0, Visit 1). Seven subsequent placebo maintenance doses were matched in volume to the IGIV-C maintenance doses, administered every third week from Week 3 (Visit 2) to Week 21 (Visit 8).

    Reporting group title
    IGIV-C
    Reporting group description
    		 Subjects were randomized to receive IGIV-C. An initial loading dose of 2 grams per kilogram (g/kg) of body weight was administered after completing baseline assessments at the Baseline Visit (Week 0, Visit 1). Seven subsequent maintenance doses of 1 g/kg of body weight were administered every third week from Week 3 (Visit 2) to Week 21 (Visit 8).

    Serious adverse events
    		 Placebo IGIV-C
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 32 (12.50%)
    5 / 30 (16.67%)
         number of deaths (all causes)
    0
    1
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Lower limb fracture
         subjects affected / exposed
    1 / 32 (3.13%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wrist fracture
         subjects affected / exposed
    1 / 32 (3.13%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiopulmonary failure
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Nervous system disorders
    Myasthenia gravis
         subjects affected / exposed
    1 / 32 (3.13%)
    3 / 30 (10.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral haemorrhage
         subjects affected / exposed
    1 / 32 (3.13%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic stroke
         subjects affected / exposed
    1 / 32 (3.13%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Haemorrhoids thrombosed
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Panic attack
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    0 / 32 (0.00%)
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo IGIV-C
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    12 / 32 (37.50%)
    18 / 30 (60.00%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    2 / 32 (6.25%)
    3 / 30 (10.00%)
         occurrences all number
    3
    5
    Nervous system disorders
    Headache
         subjects affected / exposed
    4 / 32 (12.50%)
    9 / 30 (30.00%)
         occurrences all number
    6
    22
    Myasthenia gravis
         subjects affected / exposed
    2 / 32 (6.25%)
    0 / 30 (0.00%)
         occurrences all number
    2
    0
    Dizziness
         subjects affected / exposed
    1 / 32 (3.13%)
    2 / 30 (6.67%)
         occurrences all number
    1
    2
    General disorders and administration site conditions
    Chills
         subjects affected / exposed
    0 / 32 (0.00%)
    2 / 30 (6.67%)
         occurrences all number
    0
    2
    Fatigue
         subjects affected / exposed
    0 / 32 (0.00%)
    2 / 30 (6.67%)
         occurrences all number
    0
    3
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    2 / 32 (6.25%)
    3 / 30 (10.00%)
         occurrences all number
    2
    4
    Nausea
         subjects affected / exposed
    1 / 32 (3.13%)
    3 / 30 (10.00%)
         occurrences all number
    1
    13
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 32 (0.00%)
    3 / 30 (10.00%)
         occurrences all number
    0
    4
    Catarrh
         subjects affected / exposed
    0 / 32 (0.00%)
    2 / 30 (6.67%)
         occurrences all number
    0
    3
    Dyspnoea
         subjects affected / exposed
    0 / 32 (0.00%)
    2 / 30 (6.67%)
         occurrences all number
    0
    2
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    1 / 32 (3.13%)
    2 / 30 (6.67%)
         occurrences all number
    1
    2
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 32 (0.00%)
    2 / 30 (6.67%)
         occurrences all number
    0
    2
    Back pain
         subjects affected / exposed
    1 / 32 (3.13%)
    2 / 30 (6.67%)
         occurrences all number
    1
    3
    Neck pain
         subjects affected / exposed
    0 / 32 (0.00%)
    2 / 30 (6.67%)
         occurrences all number
    0
    2
    Pain in extremity
         subjects affected / exposed
    2 / 32 (6.25%)
    1 / 30 (3.33%)
         occurrences all number
    2
    1
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    4 / 32 (12.50%)
    3 / 30 (10.00%)
         occurrences all number
    4
    3
    Upper respiratory tract infection
         subjects affected / exposed
    3 / 32 (9.38%)
    0 / 30 (0.00%)
         occurrences all number
    4
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    15 Jul 2015
    - Inclusion criteria modified including: prednisone requirement changed from 1 to 2 months prior to screening, methotrexate was included to accommodate current clinical practice patterns for MG. - Exclusion criteria modified including: clarification regarding subjects with evidence of malignancy within the past 5 years to be excluded from the study; extension of the timeframe of subjects receiving thymectomies from 3 months to 6 months; extension of timeframe of subjects receiving plasma exchange from 2 to 3 months. - The Independent Safety Review Committee was added. - Clarification provided that diphenhydramine, acetaminophen/ibuprofen, and nonsteroidal anti-inflammatory drugs were allowed as pre-medications. - Additional hemolysis laboratory assessments were added. - Hemolytic adverse reactions were defined as temporally associated with the study drug within 7 days post-infusion.

    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
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