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    Clinical Trial Results:
    A Multi Center Extension Study of PRX-102 Administered by Intravenous Infusions Every 2 Weeks for up to 60 Months to Adult Fabry Patients

    Summary
    EudraCT number
    		 2014-005544-18
    Trial protocol
    		 ES   GB  
    Global end of trial date
    26 Aug 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    18 Apr 2022
    First version publication date
    18 Apr 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    PB-102-F03
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01981720
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Protalix Ltd.
    Sponsor organisation address
    2 Snunit Street, Carmiel, Israel, 2161401
    Public contact
    Raul Chertkoff, Protalix Ltd., 972 4-902-8100, raul@protalix.com
    Scientific contact
    Sari Alon, Protalix Ltd., 972 4-902-8100, sari@protalix.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
    09 Nov 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    26 Aug 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Aug 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the ongoing safety, tolerability and efficacy parameters of pegunigalsidase alfa (PRX-102) in adult Fabry patients who have successfully completed treatment with PRX-102 in studies PB-102-F01 and PB-102-F02.
    Protection of trial subjects
    Throughout the study, infusion visits occurred EOW and at each infusion visit, vital signs were evaluated before starting the infusion, every 30 minutes during the first hour of infusion and then every 60 minutes up the end of the patient’s clinical observation period. Also, the injection site was evaluated at each infusion visit. The patients received the treatment at a home care set-up once the Investigator and Sponsor Medical Director agreed that it is safe.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    16 Jan 2014
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy, Ethical reason
    Long term follow-up duration
    		 60 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 11
    Country: Number of subjects enrolled
    Paraguay: 1
    Country: Number of subjects enrolled
    Spain: 2
    Country: Number of subjects enrolled
    United Kingdom: 1
    Worldwide total number of subjects
    15
    EEA total number of subjects
    2
    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)
    14
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Fabry patients who had completed 1 year of treatment with pegunigalsidase alfa (PRX-102) in studies PB-102-F01 and PB-102-F02 were continued to study PB-102-F03 for an additional 24-month treatment period, which was further amended to a 60-month treatment period.

    Pre-assignment
    Screening details
    		 A total of 15 adult patients (8 males and 7 females) who completed study PB-102-F02 were enrolled in this study and included in both the Safety and Efficacy populations.

    Period 1
    Period 1 title
    Patients enrolled and treated in F03 (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    Open Label

    Arms
    Arm title
    		 pegunigalsidase alfa
    Arm description
    		 pegunigalsidase alfa (PRX-102) 1mg/Kg every other week
    Arm type
    		 Experimental

    Investigational medicinal product name
    pegunigalsidase alfa
    Investigational medicinal product code
    Other name
    PRX-102
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    pegunigalsidase alfa (PRX-102) individual doses were prepared according to the each patient according to the patient's weight (measured every 6 months). PRX-102 was administered at the study dose of 1.0 mg/kg, as IV infusions, every other week (± 3 days). For patients who received 0.2 or 2.0 mg/kg in study PB-102-F02, the dose was gradually adjusted to 1.0 mg/kg during study PB-102-F03. Infusion time was reduced gradually up to 1.5 hours pending on patient tolerability.

    Number of subjects in period 1
    		pegunigalsidase alfa
    Started
    15
    Completed
    10
    Not completed
    5
         Consent withdrawn by subject
    3
         other reasons
    1
         Adverse event, non related, fatal
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Patients enrolled and treated in F03
    Reporting group description
    		 -

    Reporting group values
    		 Patients enrolled and treated in F03 Total
    Number of subjects
    		 15 15
    Age categorical
    Units: Subjects
        Adolescents (12-17 years)
    		 1 1
        Adults (18-64 years)
    		 14 14
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 33.4 ± 12.5 -
    Gender categorical
    Units: Subjects
        Female
    		 7 7
        Male
    		 8 8
    Subject analysis sets

    Subject analysis set title
    Safety population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Safety population defined as all patients who received any dose (partial or complete) of study treatment as part of study PB-102-F03

    Subject analysis set title
    Efficacy population
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Efficacy population defined as all patients who received at least one complete dose of the study treatment as part of study PB-102-F03

    Subject analysis set title
    Male
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Male subjects from safety/ efficacy population

    Subject analysis set title
    Female
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Female subjects from Safety/ efficacy population.

    Subject analysis sets values
    		 Safety population Efficacy population Male Female
    Number of subjects
    15
    15
    8
    7
    Age categorical
    Units: Subjects
        Adolescents (12-17 years)
    1
    1
    1
    0
        Adults (18-64 years)
    14
    14
    7
    7
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    33.4 ± 12.5
    33.4 ± 12.5
    29.8 ± 9.9
    37.6 ± 14.5
    Gender categorical
    Units: Subjects
        Female
    7
    7
    0
    7
        Male
    8
    8
    8
    0

    End points

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    End points reporting groups
    Reporting group title
    pegunigalsidase alfa
    Reporting group description
    		 pegunigalsidase alfa (PRX-102) 1mg/Kg every other week

    Subject analysis set title
    Safety population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Safety population defined as all patients who received any dose (partial or complete) of study treatment as part of study PB-102-F03

    Subject analysis set title
    Efficacy population
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Efficacy population defined as all patients who received at least one complete dose of the study treatment as part of study PB-102-F03

    Subject analysis set title
    Male
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Male subjects from safety/ efficacy population

    Subject analysis set title
    Female
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Female subjects from Safety/ efficacy population.

    Primary: Number of participants experiencing adverse events (AEs)

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    End point title
    		 Number of participants experiencing adverse events (AEs) [1]
    End point description
    Results represent the number of treatment-emergent adverse events (TEAE) that were considered definitely, probably or possibly related to study treatment.
    End point type
    Primary
    End point timeframe
    60 month
    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: No formal statistical analysis was specified for this study, the data was summarized using descriptive statistics.
    End point values
    		 pegunigalsidase alfa Safety population
    Number of subjects analysed
    15
    15
    Units: Subjects
        At least 1 TEAE
    15
    13
        At least 1 mild or moderate TEAE
    15
    13
        At least 1 severe TEAE
    5
    5
        At least 1 SAE
    3
    2
        At least 1 definitely, probably or possibly relate
    9
    4
        At least 1 TEAE leading to discontinuation
    1
    1
        At least 1 TEAE leading to death
    1
    1
    No statistical analyses for this end point

    Other pre-specified: Plasma Lyso-Gb3 concentration

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    End point title
    		 Plasma Lyso-Gb3 concentration
    End point description
    Globotriaosylsphingosine (Lyso-Gb3) is Fabry disease specific biomarker.
    End point type
    Other pre-specified
    End point timeframe
    60 Months
    End point values
    		 Efficacy population Male Female
    Number of subjects analysed
    15
    8
    7
    Units: ng/mL
    arithmetic mean (standard error)
        Baseline
    70.8 ± 20.4
    124.4 ± 25.9
    9.6 ± 2.1
        Month 60
    6.4 ± 1.5
    9.2 ± 1.6
    2.1 ± 0.9
        Change from Baseline to Month 60
    -68.4 ± 25
    -111.0 ± 31
    -4.6 ± 0.9
    No statistical analyses for this end point

    Other pre-specified: Estimated Glomerular Filtration Rate (eGFR)

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    End point title
    		 Estimated Glomerular Filtration Rate (eGFR)
    End point description
    eGFR was calculated based on the serum creatinine values according to the CKD-EPI equation. The absolute change in eGFR from baseline measurement at visit 1 to Month 60 was summarized using descriptive statistics.
    End point type
    Other pre-specified
    End point timeframe
    Up to 60 months.
    End point values
    		 Efficacy population Male Female
    Number of subjects analysed
    15
    8
    7
    Units: ml/min/1.73 m^2
    arithmetic mean (standard error)
        Baseline
    111.7 ± 5.5
    118.1 ± 7.7
    104.4 ± 7.5
        Month 60
    97.0 ± 6.4
    100.0 ± 8.3
    92.4 ± 11.4
        Change from Baseline to Month 60
    -10.9 ± 2.0
    -14.5 ± 1.7
    -5.6 ± 2.6
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    The AD were collected during the overall treatment period: from baseline (Visit 1 in study PB-102-F01) up to the end of study PB-102-F03 (up to 72 months per protocol).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    15.0
    Reporting groups
    Reporting group title
    All patients
    Reporting group description
    		 Analysis of AEs was preformed on TEAEs, defined as any AE occurring after the start of the first infusion of study treatment.

    Serious adverse events
    		 All patients
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 15 (20.00%)
         number of deaths (all causes)
    1
         number of deaths resulting from adverse events
    0
    Injury, poisoning and procedural complications
    Clavicle fracture
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 All patients
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    15 / 15 (100.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Anogenital warts
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Melanocytic naevus
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    3 / 15 (20.00%)
         occurrences all number
    3
    Fatigue
         subjects affected / exposed
    3 / 15 (20.00%)
         occurrences all number
    3
    Pyrexia
         subjects affected / exposed
    2 / 15 (13.33%)
         occurrences all number
    2
    Asthenia
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    2
    Feeling hot
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Infusion site bruising
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Injection site pain
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Oedema
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Oedema peripheral
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Pain
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Peripheral swelling
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Immune system disorders
    Drug hypersensitivity
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Seasonal allergy
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Reproductive system and breast disorders
    Breast tenderness
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Pruritus genital
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    5 / 15 (33.33%)
         occurrences all number
    6
    Nasal congestion
         subjects affected / exposed
    2 / 15 (13.33%)
         occurrences all number
    2
    Oropharyngeal pain
         subjects affected / exposed
    2 / 15 (13.33%)
         occurrences all number
    2
    Paranasal sinus hypersecretion
         subjects affected / exposed
    2 / 15 (13.33%)
         occurrences all number
    2
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Emphysema
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    4
    Pleuritic pain
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Pulmonary embolism
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Respiratory tract congestion
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Sleep apnoea syndrome
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Rhinorrhoea
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Sneezing
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Wheezing
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Insomnia
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    2
    Blood creatine phosphokinase increased
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    3
    Cardiac murmur
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Chest X-ray abnormal
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Electrocardiogram ST segment abnormal
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Electrocardiogram ST segment depression
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Nuclear magnetic resonance imaging abnormal
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Injury, poisoning and procedural complications
    Animal bite
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Clavicle fracture
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Contusion
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Humerus fracture
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Post-traumatic pain
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Sunburn
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Vaccination complication
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Congenital, familial and genetic disorders
    Fabry's disease
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    2
    Cardiac disorders
    Left ventricular dysfunction
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Left ventricular hypertrophy
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Palpitations
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Sinus arrhythmia
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Tachycardia
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    3
    Tricuspid valve incompetence
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Ventricular hypertrophy
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    4 / 15 (26.67%)
         occurrences all number
    12
    Paraesthesia
         subjects affected / exposed
    4 / 15 (26.67%)
         occurrences all number
    6
    Dizziness
         subjects affected / exposed
    2 / 15 (13.33%)
         occurrences all number
    3
    Balance disorder
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Burning sensation
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Migraine
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Neuralgia
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Visual field defect
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    2 / 15 (13.33%)
         occurrences all number
    3
    Vertigo
         subjects affected / exposed
    2 / 15 (13.33%)
         occurrences all number
    2
    Deafness bilateral
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Ear discomfort
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Hypoacusis
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    2
    Eye disorders
    Conjunctival haemorrhage
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    4 / 15 (26.67%)
         occurrences all number
    9
    Abdominal pain
         subjects affected / exposed
    4 / 15 (26.67%)
         occurrences all number
    9
    Diarrhoea
         subjects affected / exposed
    4 / 15 (26.67%)
         occurrences all number
    9
    Haemorrhoids
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Inguinal hernia
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Tooth disorder
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Toothache
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Vomiting
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    3 / 15 (20.00%)
         occurrences all number
    3
    Urticaria
         subjects affected / exposed
    2 / 15 (13.33%)
         occurrences all number
    2
    Acne
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Dermatitis allergic
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Dermatitis contact
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Hypohidrosis
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Night sweats
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    2 / 15 (13.33%)
         occurrences all number
    2
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    3 / 15 (20.00%)
         occurrences all number
    4
    Back pain
         subjects affected / exposed
    3 / 15 (20.00%)
         occurrences all number
    3
    Pain in extremity
         subjects affected / exposed
    3 / 15 (20.00%)
         occurrences all number
    4
    Musculoskeletal pain
         subjects affected / exposed
    2 / 15 (13.33%)
         occurrences all number
    2
    Clubbing
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Groin pain
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Intervertebral disc protrusion
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Joint swelling
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    2
    Muscle spasms
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Musculoskeletal stiffness
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Osteoarthritis
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Spondyloarthropathy
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    5 / 15 (33.33%)
         occurrences all number
    8
    Upper respiratory tract infection
         subjects affected / exposed
    5 / 15 (33.33%)
         occurrences all number
    8
    Influenza
         subjects affected / exposed
    3 / 15 (20.00%)
         occurrences all number
    4
    Gastroenteritis viral
         subjects affected / exposed
    2 / 15 (13.33%)
         occurrences all number
    2
    Bronchitis
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Gastroenteritis
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    3
    Herpes virus infection
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Lower respiratory tract infection
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    3
    Onychomycosis
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Pharyngitis
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Pneumonia
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Respiratory tract infection
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    3
    Sinusitis
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Subcutaneous abscess
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Tooth infection
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Viral infection
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    1
    Viral upper respiratory tract infection
         subjects affected / exposed
    1 / 15 (6.67%)
         occurrences all number
    5

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    05 Jan 2016
    Study extension from 24 month to 60 month.

    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.
    Small sample size.
    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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