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    Clinical Trial Results:
    A single center, open-label, dose escalation study of the safety and pharmacokinetics of rhLAMAN (recombinant human alpha-mannosidase or Lamazym) for the treatment of patients with alpha-mannosidosis.

    Summary
    EudraCT number
    		 2010-022084-36
    Trial protocol
    		 DK  
    Global end of trial date
    21 Jan 2011

    Results information
    Results version number
    		 v2(current)
    This version publication date
    29 Jul 2016
    First version publication date
    09 Aug 2015
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    Correction of the Sponsor organisation name and address.

    Trial information

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    Trial identification
    Sponsor protocol code
    rhLAMAN-02
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01268358
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Zymenex A/S
    Sponsor organisation address
    Roskildevej 12C, Hilleroed, Denmark, 3400
    Public contact
    Clinical Trial Transparency, Chiesi Farmaceutici Spa, clinicaltrials_info@chiesi.com
    Scientific contact
    Clinical Trial Transparency, Chiesi Farmaceutici Spa, clinicaltrials_info@chiesi.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-001056-PIP02-12
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    21 Jan 2011
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    21 Jan 2011
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Jan 2011
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objectives of the study are: • To evaluate the safety profile of rhLAMAN (Lamazym) • To determine the PK profile of rhLAMAN (Lamazym) in patients with alpha-mannosidosis as measured by rhLAMAN levels in plasma
    Protection of trial subjects
    The study was conducted in accordance with the declaration of Helsinki, good clinical practice (GCP) guidelines and local law requirements. Other than routine care, no specific measures for protection of trial subjects were implemented. Although an Independent Data Monitoring Committee was not formally established , a Safety Committee (SC) did exist for this study.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    24 Oct 2010
    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
    Denmark: 10
    Worldwide total number of subjects
    10
    EEA total number of subjects
    10
    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)
    5
    Adolescents (12-17 years)
    5
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 All patients were recruited at Copenhagen University Hospital, Denmark. Primary recruitment centers were: St Mary's Hospital, Manchester, UK; Children's Hospital, Mainz, DE; Hospices Civils in Lyon, FR; The Children's Memorial Health Institute, Warsaw, PL; Universitair Ziekenhuis, Brussels, BE; Hospital Universitario Reina Sofia, ES.

    Pre-assignment
    Screening details
    		 Ten patients were screened, entered the study and subsequently stratified. No patients failed screening or withdrew from treatment or study.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    The present study was open-labeled, as the primary objective of this study was to evaluate safety.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Lamazym 6.25 U/kg - Group 1
    Arm description
    		 A fixed dose regimen was chosen (6.25, 12.5, 25, 50 or 100 U/kg). The dose was determined after an evaluation at baseline and on the basis of which group the patient was stratified to (from 1-5). Each patient was to receive an infusion once a week. The number of infusions was dependant on the group number the patient was stratified to hence the onset of the first infusion for each patient. Infusions were administered weekly commencing with group 1, where patients received their first dose at Day 0 (Visit 3). One week later (7 days ± 2 days) group 2 received their first infusion (Visit 3) whereas group 1 received their second dose (Visit 4) and so on until group 5 who would have only one infusion before entering phase IIa. Group 1 was expected to receive a total of 5 doses, group 2, 4 doses and so on until group 5, which was expected to receive only 1 dose.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lamazym
    Investigational medicinal product code
    Other name
    recombinant human alpha-mannosidase
    Pharmaceutical forms
    Powder and solution for solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Patients were stratified into 5 groups (1-5) before entering the treatment phase, and each group was to receive one of the fixed doses (6.25, 12.5, 25, 50 or 100 U/kg). Treatment phase (Visit 3-12) Each patient was to receive an infusion once a week. The number of infusions was dependant on the group number the patient was stratified to hence the onset of the first infusion for each patient. Infusions were administered weekly commencing with group 1, where patients received their first dose at Day 0 (Visit 3). One week later (7 days ± 2 days) group 2 received their first infusion (Visit 3) whereas group 1 received their second dose (Visit 4) and so on until group 5 who would have only onefusion before entering phase IIa. Group 1 was expected to receive a total of 5 doses, group 2, 4 doses and so on until group 5, which was expected to receive only 1 dose.

    Arm title
    		 Lamazym 12.5 U/kg - Group 2
    Arm description
    		 A fixed dose regimen was chosen (6.25, 12.5, 25, 50 or 100 U/kg). The dose was determined after an evaluation at baseline and on the basis of which group the patient was stratified to (from 1-5). Each patient was to receive an infusion once a week. The number of infusions was dependant on the group number the patient was stratified to hence the onset of the first infusion for each patient. Infusions were administered weekly commencing with group 1, where patients received their first dose at Day 0 (Visit 3). One week later (7 days ± 2 days) group 2 received their first infusion (Visit 3) whereas group 1 received their second dose (Visit 4) and so on until group 5 who would have only one infusion before entering phase IIa.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lamazym
    Investigational medicinal product code
    Other name
    recombinant human alpha-mannosidase
    Pharmaceutical forms
    Powder and solution for solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Patients were stratified into 5 groups (1-5) before entering the treatment phase, and each group was to receive one of the fixed doses (6.25, 12.5, 25, 50 or 100 U/kg). Treatment phase (Visit 3-12) Each patient was to receive an infusion once a week. The number of infusions was dependant on the group number the patient was stratified to hence the onset of the first infusion for each patient. Infusions were administered weekly commencing with group 1, where patients received their first dose at Day 0 (Visit 3). One week later (7 days ± 2 days) group 2 received their first infusion (Visit 3) whereas group 1 received their second dose (Visit 4) and so on until group 5 who would have only onefusion before entering phase IIa. Group 1 was expected to receive a total of 5 doses, group 2, 4 doses and so on until group 5, which was expected to receive only 1 dose.

    Arm title
    		 Lamazym 25 U/kg - Group 3
    Arm description
    		 A fixed dose regimen was chosen (6.25, 12.5, 25, 50 or 100 U/kg). The dose was determined after an evaluation at baseline and on the basis of which group the patient was stratified to (from 1-5). Each patient was to receive an infusion once a week. The number of infusions was dependant on the group number the patient was stratified to hence the onset of the first infusion for each patient. Infusions were administered weekly commencing with group 1, where patients received their first dose at Day 0 (Visit 3). One week later (7 days ± 2 days) group 2 received their first infusion (Visit 3) whereas group 1 received their second dose (Visit 4) and so on until group 5 who would have only one infusion before entering phase IIa.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lamazym
    Investigational medicinal product code
    Other name
    recombinant human alpha-mannosidase
    Pharmaceutical forms
    Powder and solution for solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Patients were stratified into 5 groups (1-5) before entering the treatment phase, and each group was to receive one of the fixed doses (6.25, 12.5, 25, 50 or 100 U/kg). Treatment phase (Visit 3-12) Each patient was to receive an infusion once a week. The number of infusions was dependant on the group number the patient was stratified to hence the onset of the first infusion for each patient. Infusions were administered weekly commencing with group 1, where patients received their first dose at Day 0 (Visit 3). One week later (7 days ± 2 days) group 2 received their first infusion (Visit 3) whereas group 1 received their second dose (Visit 4) and so on until group 5 who would have only onefusion before entering phase IIa. Group 1 was expected to receive a total of 5 doses, group 2, 4 doses and so on until group 5, which was expected to receive only 1 dose.

    Arm title
    		 Lamazym 50 U/kg - Group 4
    Arm description
    		 A fixed dose regimen was chosen (6.25, 12.5, 25, 50 or 100 U/kg). The dose was determined after an evaluation at baseline and on the basis of which group the patient was stratified to (from 1-5). Each patient was to receive an infusion once a week. The number of infusions was dependant on the group number the patient was stratified to hence the onset of the first infusion for each patient. Infusions were administered weekly commencing with group 1, where patients received their first dose at Day 0 (Visit 3). One week later (7 days ± 2 days) group 2 received their first infusion (Visit 3) whereas group 1 received their second dose (Visit 4) and so on until group 5 who would have only one infusion before entering phase IIa.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lamazym
    Investigational medicinal product code
    Other name
    recombinant human alpha-mannosidase
    Pharmaceutical forms
    Powder and solution for solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Patients were stratified into 5 groups (1-5) before entering the treatment phase, and each group was to receive one of the fixed doses (6.25, 12.5, 25, 50 or 100 U/kg). Treatment phase (Visit 3-12) Each patient was to receive an infusion once a week. The number of infusions was dependant on the group number the patient was stratified to hence the onset of the first infusion for each patient. Infusions were administered weekly commencing with group 1, where patients received their first dose at Day 0 (Visit 3). One week later (7 days ± 2 days) group 2 received their first infusion (Visit 3) whereas group 1 received their second dose (Visit 4) and so on until group 5 who would have only onefusion before entering phase IIa. Group 1 was expected to receive a total of 5 doses, group 2, 4 doses and so on until group 5, which was expected to receive only 1 dose.

    Arm title
    		 Lamazym 100 U/kg - Group 5
    Arm description
    		 A fixed dose regimen was chosen (6.25, 12.5, 25, 50 or 100 U/kg). The dose was determined after an evaluation at baseline and on the basis of which group the patient was stratified to (from 1-5). Each patient was to receive an infusion once a week. The number of infusions was dependant on the group number the patient was stratified to hence the onset of the first infusion for each patient. Infusions were administered weekly commencing with group 1, where patients received their first dose at Day 0 (Visit 3). One week later (7 days ± 2 days) group 2 received their first infusion (Visit 3) whereas group 1 received their second dose (Visit 4) and so on until group 5 who would have only one infusion before entering phase IIa.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lamazym
    Investigational medicinal product code
    Other name
    recombinant human alpha-mannosidase
    Pharmaceutical forms
    Powder and solution for solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Patients were stratified into 5 groups (1-5) before entering the treatment phase, and each group was to receive one of the fixed doses (6.25, 12.5, 25, 50 or 100 U/kg). Treatment phase (Visit 3-12) Each patient was to receive an infusion once a week. The number of infusions was dependant on the group number the patient was stratified to hence the onset of the first infusion for each patient. Infusions were administered weekly commencing with group 1, where patients received their first dose at Day 0 (Visit 3). One week later (7 days ± 2 days) group 2 received their first infusion (Visit 3) whereas group 1 received their second dose (Visit 4) and so on until group 5 who would have only onefusion before entering phase IIa. Group 1 was expected to receive a total of 5 doses, group 2, 4 doses and so on until group 5, which was expected to receive only 1 dose.

    Number of subjects in period 1
    		Lamazym 6.25 U/kg - Group 1 Lamazym 12.5 U/kg - Group 2 Lamazym 25 U/kg - Group 3 Lamazym 50 U/kg - Group 4 Lamazym 100 U/kg - Group 5
    Started
    2
    2
    2
    2
    2
    Completed
    2
    2
    2
    2
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Lamazym 6.25 U/kg - Group 1
    Reporting group description
    		 A fixed dose regimen was chosen (6.25, 12.5, 25, 50 or 100 U/kg). The dose was determined after an evaluation at baseline and on the basis of which group the patient was stratified to (from 1-5). Each patient was to receive an infusion once a week. The number of infusions was dependant on the group number the patient was stratified to hence the onset of the first infusion for each patient. Infusions were administered weekly commencing with group 1, where patients received their first dose at Day 0 (Visit 3). One week later (7 days ± 2 days) group 2 received their first infusion (Visit 3) whereas group 1 received their second dose (Visit 4) and so on until group 5 who would have only one infusion before entering phase IIa. Group 1 was expected to receive a total of 5 doses, group 2, 4 doses and so on until group 5, which was expected to receive only 1 dose.

    Reporting group title
    Lamazym 12.5 U/kg - Group 2
    Reporting group description
    		 A fixed dose regimen was chosen (6.25, 12.5, 25, 50 or 100 U/kg). The dose was determined after an evaluation at baseline and on the basis of which group the patient was stratified to (from 1-5). Each patient was to receive an infusion once a week. The number of infusions was dependant on the group number the patient was stratified to hence the onset of the first infusion for each patient. Infusions were administered weekly commencing with group 1, where patients received their first dose at Day 0 (Visit 3). One week later (7 days ± 2 days) group 2 received their first infusion (Visit 3) whereas group 1 received their second dose (Visit 4) and so on until group 5 who would have only one infusion before entering phase IIa.

    Reporting group title
    Lamazym 25 U/kg - Group 3
    Reporting group description
    		 A fixed dose regimen was chosen (6.25, 12.5, 25, 50 or 100 U/kg). The dose was determined after an evaluation at baseline and on the basis of which group the patient was stratified to (from 1-5). Each patient was to receive an infusion once a week. The number of infusions was dependant on the group number the patient was stratified to hence the onset of the first infusion for each patient. Infusions were administered weekly commencing with group 1, where patients received their first dose at Day 0 (Visit 3). One week later (7 days ± 2 days) group 2 received their first infusion (Visit 3) whereas group 1 received their second dose (Visit 4) and so on until group 5 who would have only one infusion before entering phase IIa.

    Reporting group title
    Lamazym 50 U/kg - Group 4
    Reporting group description
    		 A fixed dose regimen was chosen (6.25, 12.5, 25, 50 or 100 U/kg). The dose was determined after an evaluation at baseline and on the basis of which group the patient was stratified to (from 1-5). Each patient was to receive an infusion once a week. The number of infusions was dependant on the group number the patient was stratified to hence the onset of the first infusion for each patient. Infusions were administered weekly commencing with group 1, where patients received their first dose at Day 0 (Visit 3). One week later (7 days ± 2 days) group 2 received their first infusion (Visit 3) whereas group 1 received their second dose (Visit 4) and so on until group 5 who would have only one infusion before entering phase IIa.

    Reporting group title
    Lamazym 100 U/kg - Group 5
    Reporting group description
    		 A fixed dose regimen was chosen (6.25, 12.5, 25, 50 or 100 U/kg). The dose was determined after an evaluation at baseline and on the basis of which group the patient was stratified to (from 1-5). Each patient was to receive an infusion once a week. The number of infusions was dependant on the group number the patient was stratified to hence the onset of the first infusion for each patient. Infusions were administered weekly commencing with group 1, where patients received their first dose at Day 0 (Visit 3). One week later (7 days ± 2 days) group 2 received their first infusion (Visit 3) whereas group 1 received their second dose (Visit 4) and so on until group 5 who would have only one infusion before entering phase IIa.

    Reporting group values
    		 Lamazym 6.25 U/kg - Group 1 Lamazym 12.5 U/kg - Group 2 Lamazym 25 U/kg - Group 3 Lamazym 50 U/kg - Group 4 Lamazym 100 U/kg - Group 5 Total
    Number of subjects
    		 2 2 2 2 2 10
    Age categorical
    Units: Subjects
        Children (2-11 years)
    		 0 1 2 1 0 4
        Adolescents (12-17 years)
    		 2 1 0 1 2 6
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 15.1 ( 0.1 ) 13.2 ( 3.9 ) 8.1 ( 0.5 ) 9.8 ( 3.1 ) 16.7 ( 1.2 ) -
    Gender categorical
    Units: Subjects
        Female
    		 0 1 2 0 0 3
        Male
    		 2 1 0 2 2 7

    End points

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    End points reporting groups
    Reporting group title
    Lamazym 6.25 U/kg - Group 1
    Reporting group description
    		 A fixed dose regimen was chosen (6.25, 12.5, 25, 50 or 100 U/kg). The dose was determined after an evaluation at baseline and on the basis of which group the patient was stratified to (from 1-5). Each patient was to receive an infusion once a week. The number of infusions was dependant on the group number the patient was stratified to hence the onset of the first infusion for each patient. Infusions were administered weekly commencing with group 1, where patients received their first dose at Day 0 (Visit 3). One week later (7 days ± 2 days) group 2 received their first infusion (Visit 3) whereas group 1 received their second dose (Visit 4) and so on until group 5 who would have only one infusion before entering phase IIa. Group 1 was expected to receive a total of 5 doses, group 2, 4 doses and so on until group 5, which was expected to receive only 1 dose.

    Reporting group title
    Lamazym 12.5 U/kg - Group 2
    Reporting group description
    		 A fixed dose regimen was chosen (6.25, 12.5, 25, 50 or 100 U/kg). The dose was determined after an evaluation at baseline and on the basis of which group the patient was stratified to (from 1-5). Each patient was to receive an infusion once a week. The number of infusions was dependant on the group number the patient was stratified to hence the onset of the first infusion for each patient. Infusions were administered weekly commencing with group 1, where patients received their first dose at Day 0 (Visit 3). One week later (7 days ± 2 days) group 2 received their first infusion (Visit 3) whereas group 1 received their second dose (Visit 4) and so on until group 5 who would have only one infusion before entering phase IIa.

    Reporting group title
    Lamazym 25 U/kg - Group 3
    Reporting group description
    		 A fixed dose regimen was chosen (6.25, 12.5, 25, 50 or 100 U/kg). The dose was determined after an evaluation at baseline and on the basis of which group the patient was stratified to (from 1-5). Each patient was to receive an infusion once a week. The number of infusions was dependant on the group number the patient was stratified to hence the onset of the first infusion for each patient. Infusions were administered weekly commencing with group 1, where patients received their first dose at Day 0 (Visit 3). One week later (7 days ± 2 days) group 2 received their first infusion (Visit 3) whereas group 1 received their second dose (Visit 4) and so on until group 5 who would have only one infusion before entering phase IIa.

    Reporting group title
    Lamazym 50 U/kg - Group 4
    Reporting group description
    		 A fixed dose regimen was chosen (6.25, 12.5, 25, 50 or 100 U/kg). The dose was determined after an evaluation at baseline and on the basis of which group the patient was stratified to (from 1-5). Each patient was to receive an infusion once a week. The number of infusions was dependant on the group number the patient was stratified to hence the onset of the first infusion for each patient. Infusions were administered weekly commencing with group 1, where patients received their first dose at Day 0 (Visit 3). One week later (7 days ± 2 days) group 2 received their first infusion (Visit 3) whereas group 1 received their second dose (Visit 4) and so on until group 5 who would have only one infusion before entering phase IIa.

    Reporting group title
    Lamazym 100 U/kg - Group 5
    Reporting group description
    		 A fixed dose regimen was chosen (6.25, 12.5, 25, 50 or 100 U/kg). The dose was determined after an evaluation at baseline and on the basis of which group the patient was stratified to (from 1-5). Each patient was to receive an infusion once a week. The number of infusions was dependant on the group number the patient was stratified to hence the onset of the first infusion for each patient. Infusions were administered weekly commencing with group 1, where patients received their first dose at Day 0 (Visit 3). One week later (7 days ± 2 days) group 2 received their first infusion (Visit 3) whereas group 1 received their second dose (Visit 4) and so on until group 5 who would have only one infusion before entering phase IIa.

    Primary: rhLaman level in plasma

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    End point title
    		 rhLaman level in plasma
    End point description
    The rhLaman level in plasma is measured as AUC.
    End point type
    Primary
    End point timeframe
    At Visit 3 (first dose)
    End point values
    		 Lamazym 6.25 U/kg - Group 1 Lamazym 12.5 U/kg - Group 2 Lamazym 25 U/kg - Group 3 Lamazym 50 U/kg - Group 4 Lamazym 100 U/kg - Group 5
    Number of subjects analysed
    2
    2
    2
    2
    2
    Units: μg*h/L
        arithmetic mean (standard deviation)
    12221 ( 7388 )
    54684 ( 14056 )
    101930 ( 27336 )
    268538 ( 44872 )
    697375 ( 264080 )
    Statistical analysis title
    		 Evaluation of dose proportionality
    Comparison groups
    Lamazym 6.25 U/kg - Group 1 v Lamazym 12.5 U/kg - Group 2 v Lamazym 25 U/kg - Group 3 v Lamazym 50 U/kg - Group 4 v Lamazym 100 U/kg - Group 5
    Number of subjects included in analysis
    10
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    Method
    Parameter type
    		 linear regression model
    Point estimate
    1.42
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 1.19
         upper limit
    		 1.64
    Notes
    [1] - This is a dose finding (dose-escalation) study

    Secondary: DBP

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    End point title
    		 DBP
    End point description
    Only descriptive statistical data of Diastolic Blood Pressure at Visit 3 - 24 Hours 30 Minutes Post Infusion Stop are reported here.
    End point type
    Secondary
    End point timeframe
    At Visit 3, 4, 5, 6 and 7 (pre-infusion, multiple post infusion start and multiple post infusion stop timepoints)
    End point values
    		 Lamazym 6.25 U/kg - Group 1 Lamazym 12.5 U/kg - Group 2 Lamazym 25 U/kg - Group 3 Lamazym 50 U/kg - Group 4 Lamazym 100 U/kg - Group 5
    Number of subjects analysed
    2
    2
    2
    2
    2
    Units: mmHg
        arithmetic mean (standard deviation)
    81 ( 2.8 )
    59.5 ( 2.1 )
    66.5 ( 0.7 )
    70 ( 12.5 )
    69 ( 1.4 )
    No statistical analyses for this end point

    Secondary: SBP

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    End point title
    		 SBP
    End point description
    Only descriptive statistical data on Visit 3 - 24h post infusion stop are reported here.
    End point type
    Secondary
    End point timeframe
    At Visit 3, 4, 5, 6 and 7 (pre-infusion, multiple post infusion start and multiple post infusion stop timepoints).
    End point values
    		 Lamazym 6.25 U/kg - Group 1 Lamazym 12.5 U/kg - Group 2 Lamazym 25 U/kg - Group 3 Lamazym 50 U/kg - Group 4 Lamazym 100 U/kg - Group 5
    Number of subjects analysed
    2
    2
    2
    2
    2
    Units: mmHg
        arithmetic mean (standard deviation)
    142 ( 2.8 )
    112.5 ( 2.1 )
    95.5 ( 10.6 )
    113.5 ( 13.4 )
    135 ( 2.8 )
    No statistical analyses for this end point

    Secondary: Heart rate

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    End point title
    		 Heart rate
    End point description
    Only descriptive statistical data at Visit 3 - 24 h post infusion stop are reported here.
    End point type
    Secondary
    End point timeframe
    At Visit 3, 4, 5, 6 and 7 (pre-infusion, multiple post infusion start and multiple post infusion stop timepoints)
    End point values
    		 Lamazym 6.25 U/kg - Group 1 Lamazym 12.5 U/kg - Group 2 Lamazym 25 U/kg - Group 3 Lamazym 50 U/kg - Group 4 Lamazym 100 U/kg - Group 5
    Number of subjects analysed
    2
    2
    2
    2
    2
    Units: bpm
        arithmetic mean (standard deviation)
    101 ( 1.4 )
    69 ( 22.6 )
    93 ( 1.4 )
    81 ( 18.4 )
    64.5 ( 3.5 )
    No statistical analyses for this end point

    Secondary: Temperature

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    End point title
    		 Temperature
    End point description
    Only descriptive statistical data at Visit 3 - 24 h post infusion stop are reported here.
    End point type
    Secondary
    End point timeframe
    At Visit 3, 4, 5, 6 and 7 (pre-infusion, multiple post infusion start and multiple post infusion stop timepoints).
    End point values
    		 Lamazym 6.25 U/kg - Group 1 Lamazym 12.5 U/kg - Group 2 Lamazym 25 U/kg - Group 3 Lamazym 50 U/kg - Group 4 Lamazym 100 U/kg - Group 5
    Number of subjects analysed
    2
    2
    2
    2
    2
    Units: Celsius degrees
        arithmetic mean (standard deviation)
    36.8 ( 1 )
    36.9 ( 0.1 )
    37.6 ( 0.5 )
    36.8 ( 0.1 )
    37.7 ( 0.4 )
    No statistical analyses for this end point

    Secondary: Respiration rate

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    End point title
    		 Respiration rate
    End point description
    Only descriptive statistical data at Visit 3 - 24 h post infusion stop are reported here.
    End point type
    Secondary
    End point timeframe
    At Visit 3, 4, 5, 6 and 7 (pre-infusion, multiple post infusion start and multiple post infusion stop timepoints).
    End point values
    		 Lamazym 6.25 U/kg - Group 1 Lamazym 12.5 U/kg - Group 2 Lamazym 25 U/kg - Group 3 Lamazym 50 U/kg - Group 4 Lamazym 100 U/kg - Group 5
    Number of subjects analysed
    2
    2
    2
    2
    2
    Units: beats/min
        arithmetic mean (standard deviation)
    27 ( 4.2 )
    21 ( 4.2 )
    21 ( 1.4 )
    21 ( 1.4 )
    20 ( 0 )
    No statistical analyses for this end point

    Secondary: Hematology - Basophilocytes

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    End point title
    		 Hematology - Basophilocytes
    End point description
    Only descriptive statistical data at Visit 3 - 24 h post infusion stop are reported here.
    End point type
    Secondary
    End point timeframe
    At Visit 2 (baseline), 3 (pre infusion, 24 h post infusion stop), and 7 (pre-infusion)
    End point values
    		 Lamazym 6.25 U/kg - Group 1 Lamazym 12.5 U/kg - Group 2 Lamazym 25 U/kg - Group 3 Lamazym 50 U/kg - Group 4 Lamazym 100 U/kg - Group 5
    Number of subjects analysed
    2
    2
    2
    2
    2
    Units: 10E9/L
        arithmetic mean (standard deviation)
    0.05 ( 0.07 )
    0.1 ( 0 )
    0 ( 0 )
    0.05 ( 0.07 )
    0.05 ( 0.07 )
    No statistical analyses for this end point

    Secondary: Hematology - Eosinophilocytes

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    End point title
    		 Hematology - Eosinophilocytes
    End point description
    Only descriptive statistical data at Visit 3 - 24 h post infusion stop are reported here.
    End point type
    Secondary
    End point timeframe
    At Visit 2 (baseline), 3 (pre infusion, 24 h post infusion stop), and 7 (pre-infusion)
    End point values
    		 Lamazym 6.25 U/kg - Group 1 Lamazym 12.5 U/kg - Group 2 Lamazym 25 U/kg - Group 3 Lamazym 50 U/kg - Group 4 Lamazym 100 U/kg - Group 5
    Number of subjects analysed
    2
    2
    2
    2
    2
    Units: 10E9/L
        arithmetic mean (standard deviation)
    0.1 ( 0 )
    0.05 ( 0.07 )
    0.15 ( 0.21 )
    0.05 ( 0.07 )
    0.8 ( 0.99 )
    No statistical analyses for this end point

    Secondary: Hematology - Haemoglobin (Fe)

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    End point title
    		 Hematology - Haemoglobin (Fe)
    End point description
    Only descriptive statistical data at Visit 3 - 24 h post infusion stop are reported here.
    End point type
    Secondary
    End point timeframe
    At Visit 2 (baseline), 3 (pre infusion, 24 h post infusion stop), and 7 (pre-infusion)
    End point values
    		 Lamazym 6.25 U/kg - Group 1 Lamazym 12.5 U/kg - Group 2 Lamazym 25 U/kg - Group 3 Lamazym 50 U/kg - Group 4 Lamazym 100 U/kg - Group 5
    Number of subjects analysed
    2
    2
    2
    2
    2
    Units: mmol/L
        arithmetic mean (standard deviation)
    9.5 ( 0.14 )
    7.7 ( 0.28 )
    7.45 ( 0.35 )
    7.05 ( 0.78 )
    9 ( 0.57 )
    No statistical analyses for this end point

    Secondary: Hematology - Mean cell haemoglobin concentration

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    End point title
    		 Hematology - Mean cell haemoglobin concentration
    End point description
    Only descriptive statistical data at Visit 3 - 24 h post infusion stop are reported here.
    End point type
    Secondary
    End point timeframe
    At Visit 2 (baseline), 3 (pre infusion, 24 h post infusion stop), and 7 (pre-infusion)
    End point values
    		 Lamazym 6.25 U/kg - Group 1 Lamazym 12.5 U/kg - Group 2 Lamazym 25 U/kg - Group 3 Lamazym 50 U/kg - Group 4 Lamazym 100 U/kg - Group 5
    Number of subjects analysed
    2
    2
    2
    2
    2
    Units: mmol/L
        arithmetic mean (standard deviation)
    21.5 ( 0.7 )
    21 ( 0 )
    21 ( 0 )
    21 ( 0 )
    21 ( 0 )
    No statistical analyses for this end point

    Secondary: Hematology - Mean cell haemoglobin

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    End point title
    		 Hematology - Mean cell haemoglobin
    End point description
    Only descriptive statistical data at Visit 3 - 24 h post infusion stop are reported here.
    End point type
    Secondary
    End point timeframe
    At Visit 2 (baseline), 3 (pre infusion, 24 h post infusion stop), and 7 (pre-infusion)
    End point values
    		 Lamazym 6.25 U/kg - Group 1 Lamazym 12.5 U/kg - Group 2 Lamazym 25 U/kg - Group 3 Lamazym 50 U/kg - Group 4 Lamazym 100 U/kg - Group 5
    Number of subjects analysed
    2
    2
    2
    2
    2
    Units: fmol
        arithmetic mean (standard deviation)
    1.85 ( 0.07 )
    1.85 ( 0.21 )
    1.75 ( 0.07 )
    1.65 ( 0.07 )
    1.8 ( 0.14 )
    No statistical analyses for this end point

    Secondary: Hematology - Lymphocytes

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    End point title
    		 Hematology - Lymphocytes
    End point description
    Only descriptive statistical data at Visit 3 - 24 h post infusion stop are reported here.
    End point type
    Secondary
    End point timeframe
    At Visit 2 (baseline), 3 (pre infusion, 24 h post infusion stop), and 7 (pre-infusion)
    End point values
    		 Lamazym 6.25 U/kg - Group 1 Lamazym 12.5 U/kg - Group 2 Lamazym 25 U/kg - Group 3 Lamazym 50 U/kg - Group 4 Lamazym 100 U/kg - Group 5
    Number of subjects analysed
    2
    2
    2
    2
    2
    Units: 10E9/L
        arithmetic mean (standard deviation)
    1.65 ( 0.49 )
    1.45 ( 0.21 )
    1.6 ( 0.57 )
    2.3 ( 0.42 )
    3.05 ( 1.06 )
    No statistical analyses for this end point

    Secondary: Hematology - Monocytes

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    End point title
    		 Hematology - Monocytes
    End point description
    Only descriptive statistical data at Visit 3 - 24 h post infusion stop are reported here.
    End point type
    Secondary
    End point timeframe
    At Visit 2 (baseline), 3 (pre infusion, 24 h post infusion stop), and 7 (pre-infusion).
    End point values
    		 Lamazym 6.25 U/kg - Group 1 Lamazym 12.5 U/kg - Group 2 Lamazym 25 U/kg - Group 3 Lamazym 50 U/kg - Group 4 Lamazym 100 U/kg - Group 5
    Number of subjects analysed
    2
    2
    2
    2
    2
    Units: 10E9/L
        arithmetic mean (standard deviation)
    0.35 ( 0.07 )
    0.4 ( 0.14 )
    0.1 ( 0 )
    0.3 ( 0 )
    0.35 ( 0.21 )
    No statistical analyses for this end point

    Secondary: Hematology - Neutrophilocytes

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    End point title
    		 Hematology - Neutrophilocytes
    End point description
    Only descriptive statistical data at Visit 3 - 24 h post infusion stop are reported here.
    End point type
    Secondary
    End point timeframe
    At Visit 2 (baseline), 3 (pre infusion, 24 h post infusion stop), and 7 (pre-infusion)
    End point values
    		 Lamazym 6.25 U/kg - Group 1 Lamazym 12.5 U/kg - Group 2 Lamazym 25 U/kg - Group 3 Lamazym 50 U/kg - Group 4 Lamazym 100 U/kg - Group 5
    Number of subjects analysed
    2
    2
    2
    2
    2
    Units: 10E9/L
        arithmetic mean (standard deviation)
    2.85 ( 1.63 )
    2.85 ( 0.64 )
    2.5 ( 0.92 )
    2.1 ( 0.28 )
    3.15 ( 1.34 )
    No statistical analyses for this end point

    Secondary: Hematology - Platelets

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    End point title
    		 Hematology - Platelets
    End point description
    Only descriptive statistical data at Visit 3 - 24 h post infusion stop are reported here.
    End point type
    Secondary
    End point timeframe
    At Visit 2 (baseline), 3 (pre infusion, 24 h post infusion stop), and 7 (pre-infusion)
    End point values
    		 Lamazym 6.25 U/kg - Group 1 Lamazym 12.5 U/kg - Group 2 Lamazym 25 U/kg - Group 3 Lamazym 50 U/kg - Group 4 Lamazym 100 U/kg - Group 5
    Number of subjects analysed
    2
    2
    2
    2
    2
    Units: 10E9/L
        arithmetic mean (standard deviation)
    206.5 ( 30.4 )
    177 ( 7.1 )
    223.5 ( 60.1 )
    167.5 ( 14.8 )
    194.5 ( 12 )
    No statistical analyses for this end point

    Secondary: Hematology - Erythrocytes

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    End point title
    		 Hematology - Erythrocytes
    End point description
    Only descriptive statistical data at Visit 3 - 24 h post infusion stop are reported here.
    End point type
    Secondary
    End point timeframe
    At Visit 2 (baseline), 3 (pre infusion, 24 h post infusion stop), and 7 (pre-infusion)
    End point values
    		 Lamazym 6.25 U/kg - Group 1 Lamazym 12.5 U/kg - Group 2 Lamazym 25 U/kg - Group 3 Lamazym 50 U/kg - Group 4 Lamazym 100 U/kg - Group 5
    Number of subjects analysed
    2
    2
    2
    2
    2
    Units: 10E12/L
        arithmetic mean (standard deviation)
    5.1 ( 0.14 )
    4.2 ( 0.42 )
    4.2 ( 0 )
    4.25 ( 0.35 )
    5.05 ( 0.64 )
    No statistical analyses for this end point

    Secondary: Hematology - Leucocytes

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    End point title
    		 Hematology - Leucocytes
    End point description
    Only descriptive statistical data at Visit 3 - 24 h post infusion stop are reported here.
    End point type
    Secondary
    End point timeframe
    At Visit 2 (baseline), 3 (pre infusion, 24 h post infusion stop), and 7 (pre-infusion)
    End point values
    		 Lamazym 6.25 U/kg - Group 1 Lamazym 12.5 U/kg - Group 2 Lamazym 25 U/kg - Group 3 Lamazym 50 U/kg - Group 4 Lamazym 100 U/kg - Group 5
    Number of subjects analysed
    2
    2
    2
    2
    2
    Units: 10E9/L
        arithmetic mean (standard deviation)
    4.95 ( 1.06 )
    4.75 ( 0.21 )
    3.95 ( 0.07 )
    4.8 ( 0.14 )
    7.35 ( 3.61 )
    No statistical analyses for this end point

    Secondary: Blood Chemistry - S-Alat

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    End point title
    		 Blood Chemistry - S-Alat
    End point description
    Only descriptive statistical data at Visit 3 - 24 h post infusion stop are reported here.
    End point type
    Secondary
    End point timeframe
    At Visit 2 (baseline), 3 (pre infusion, 24 h post infusion stop), and 7 (pre-infusion).
    End point values
    		 Lamazym 6.25 U/kg - Group 1 Lamazym 12.5 U/kg - Group 2 Lamazym 25 U/kg - Group 3 Lamazym 50 U/kg - Group 4 Lamazym 100 U/kg - Group 5
    Number of subjects analysed
    2
    2
    2
    2
    2
    Units: U/L
        arithmetic mean (standard deviation)
    14.5 ( 3.5 )
    18.5 ( 7.8 )
    15 ( 4.2 )
    25 ( 11.3 )
    14 ( 1.4 )
    No statistical analyses for this end point

    Secondary: Blood chemistry - S-Alkaline phosphatase

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    End point title
    		 Blood chemistry - S-Alkaline phosphatase
    End point description
    Only descriptive statistical data at Visit 3 - 24 h post infusion stop are reported here.
    End point type
    Secondary
    End point timeframe
    At Visit 2 (baseline), 3 (pre infusion, 24 h post infusion stop), and 7 (pre-infusion).
    End point values
    		 Lamazym 6.25 U/kg - Group 1 Lamazym 12.5 U/kg - Group 2 Lamazym 25 U/kg - Group 3 Lamazym 50 U/kg - Group 4 Lamazym 100 U/kg - Group 5
    Number of subjects analysed
    2
    2
    2
    2
    2
    Units: U/L
        arithmetic mean (standard deviation)
    121.5 ( 19.1 )
    183 ( 124.5 )
    246 ( 79.2 )
    248.5 ( 106.8 )
    120.5 ( 13.4 )
    No statistical analyses for this end point

    Secondary: Blood chemistry - S-Amilase

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    End point title
    		 Blood chemistry - S-Amilase
    End point description
    Only descriptive statistical data at Visit 3 - 24 h post infusion stop are reported here.
    End point type
    Secondary
    End point timeframe
    At Visit 2 (baseline), 3 (pre infusion, 24 h post infusion stop), and 7 (pre-infusion)
    End point values
    		 Lamazym 6.25 U/kg - Group 1 Lamazym 12.5 U/kg - Group 2 Lamazym 25 U/kg - Group 3 Lamazym 50 U/kg - Group 4 Lamazym 100 U/kg - Group 5
    Number of subjects analysed
    2
    2
    2
    2
    2
    Units: U/L
        arithmetic mean (standard deviation)
    57 ( 8.5 )
    52 ( 4.2 )
    43 ( 24 )
    35.5 ( 3.5 )
    63 ( 2.8 )
    No statistical analyses for this end point

    Secondary: Blood chemistry - S-Bilirubin

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    End point title
    		 Blood chemistry - S-Bilirubin
    End point description
    Only descriptive statistical data at Visit 3 - 24 h post infusion stop are reported here.
    End point type
    Secondary
    End point timeframe
    At Visit 2 (baseline), 3 (pre infusion, 24 h post infusion stop), and 7 (pre-infusion)
    End point values
    		 Lamazym 6.25 U/kg - Group 1 Lamazym 12.5 U/kg - Group 2 Lamazym 25 U/kg - Group 3 Lamazym 50 U/kg - Group 4 Lamazym 100 U/kg - Group 5
    Number of subjects analysed
    2
    2
    2
    2
    2
    Units: μmol/L
        arithmetic mean (standard deviation)
    23 ( 4.2 )
    23.5 ( 23.3 )
    8.5 ( 0.7 )
    6 ( 2.8 )
    17 ( 8.5 )
    No statistical analyses for this end point

    Secondary: Blood chemistry - S-Calcium

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    End point title
    		 Blood chemistry - S-Calcium
    End point description
    Only descriptive statistical data at Visit 3 - 24 h post infusion stop are reported here.
    End point type
    Secondary
    End point timeframe
    At Visit 2 (baseline), 3 (pre infusion, 24 h post infusion stop), and 7 (pre-infusion)
    End point values
    		 Lamazym 6.25 U/kg - Group 1 Lamazym 12.5 U/kg - Group 2 Lamazym 25 U/kg - Group 3 Lamazym 50 U/kg - Group 4 Lamazym 100 U/kg - Group 5
    Number of subjects analysed
    2
    2
    2
    2
    2
    Units: mmol/L
        arithmetic mean (standard deviation)
    2.36 ( 0.01 )
    2.38 ( 0.14 )
    2.36 ( 0.04 )
    2.37 ( 0.04 )
    2.4 ( 0.02 )
    No statistical analyses for this end point

    Secondary: Blood chemistry - S-Creatin kinase

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    End point title
    		 Blood chemistry - S-Creatin kinase
    End point description
    Only descriptive statistical data at Visit 3 - 24 h post infusion stop are reported here.
    End point type
    Secondary
    End point timeframe
    At Visit 2 (baseline), 3 (pre infusion, 24 h post infusion stop), and 7 (pre-infusion)
    End point values
    		 Lamazym 6.25 U/kg - Group 1 Lamazym 12.5 U/kg - Group 2 Lamazym 25 U/kg - Group 3 Lamazym 50 U/kg - Group 4 Lamazym 100 U/kg - Group 5
    Number of subjects analysed
    2
    2
    2
    2
    2
    Units: U/L
        arithmetic mean (standard deviation)
    74.5 ( 20.5 )
    61 ( 22.6 )
    63 ( 5.7 )
    102.5 ( 50.2 )
    72.5 ( 23.3 )
    No statistical analyses for this end point

    Secondary: Blood chemistry - S-Creatininium substr.c.

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    End point title
    		 Blood chemistry - S-Creatininium substr.c.
    End point description
    Only descriptive statistical data at Visit 3 - 24 h post infusion stop are reported here.
    End point type
    Secondary
    End point timeframe
    At Visit 2 (baseline), 3 (pre infusion, 24 h post infusion stop), and 7 (pre-infusion)
    End point values
    		 Lamazym 6.25 U/kg - Group 1 Lamazym 12.5 U/kg - Group 2 Lamazym 25 U/kg - Group 3 Lamazym 50 U/kg - Group 4 Lamazym 100 U/kg - Group 5
    Number of subjects analysed
    2
    2
    2
    2
    2
    Units: μmol/L
        arithmetic mean (standard deviation)
    88.5 ( 7.8 )
    67.5 ( 0.7 )
    61 ( 2.8 )
    63.5 ( 9.2 )
    83 ( 4.2 )
    No statistical analyses for this end point

    Secondary: Blood chemistry - S-Potassium ion subst.c.

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    End point title
    		 Blood chemistry - S-Potassium ion subst.c.
    End point description
    Only descriptive statistical data at Visit 3 - 24 h post infusion stop are reported here.
    End point type
    Secondary
    End point timeframe
    At Visit 2 (baseline), 3 (pre infusion, 24 h post infusion stop), and 7 (pre-infusion)
    End point values
    		 Lamazym 6.25 U/kg - Group 1 Lamazym 12.5 U/kg - Group 2 Lamazym 25 U/kg - Group 3 Lamazym 50 U/kg - Group 4 Lamazym 100 U/kg - Group 5
    Number of subjects analysed
    2
    2
    2
    2
    2
    Units: mmol/L
        arithmetic mean (standard deviation)
    3.65 ( 0.21 )
    3.85 ( 0.07 )
    4 ( 0 )
    4.05 ( 0.07 )
    3.65 ( 0.07 )
    No statistical analyses for this end point

    Secondary: Blood Chemistry - S-LDH

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    End point title
    		 Blood Chemistry - S-LDH
    End point description
    Only descriptive statistical data at Visit 3 - 24 h post infusion stop are reported here.
    End point type
    Secondary
    End point timeframe
    At Visit 2 (baseline), 3 (pre infusion, 24 h post infusion stop), and 7 (pre-infusion).
    End point values
    		 Lamazym 6.25 U/kg - Group 1 Lamazym 12.5 U/kg - Group 2 Lamazym 25 U/kg - Group 3 Lamazym 50 U/kg - Group 4 Lamazym 100 U/kg - Group 5
    Number of subjects analysed
    2
    2
    2
    2
    2
    Units: U/L
        arithmetic mean (standard deviation)
    183.5 ( 3.5 )
    187.5 ( 94 )
    214.5 ( 10.6 )
    232.5 ( 21.9 )
    187.5 ( 4.9 )
    No statistical analyses for this end point

    Secondary: Blood Chemistry - S-Phosphate inorg.

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    End point title
    		 Blood Chemistry - S-Phosphate inorg.
    End point description
    Only descriptive statistical data at Visit 3 - 24 h post infusion stop are reported here.
    End point type
    Secondary
    End point timeframe
    At Visit 2 (baseline), 3 (pre infusion, 24 h post infusion stop), and 7 (pre-infusion)
    End point values
    		 Lamazym 6.25 U/kg - Group 1 Lamazym 12.5 U/kg - Group 2 Lamazym 25 U/kg - Group 3 Lamazym 50 U/kg - Group 4 Lamazym 100 U/kg - Group 5
    Number of subjects analysed
    2
    2
    2
    2
    2
    Units: mmol/L
        arithmetic mean (standard deviation)
    1.03 ( 0.04 )
    1.04 ( 0.03 )
    1.32 ( 0.11 )
    1.3 ( 0.18 )
    1.09 ( 0 )
    No statistical analyses for this end point

    Secondary: Blood Chemistry - S-Sodium ion

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    End point title
    		 Blood Chemistry - S-Sodium ion
    End point description
    Only descriptive statistical data at Visit 3 - 24 h post infusion stop are reported here.
    End point type
    Secondary
    End point timeframe
    At Visit 2 (baseline), 3 (pre infusion, 24 h post infusion stop), and 7 (pre-infusion)
    End point values
    		 Lamazym 6.25 U/kg - Group 1 Lamazym 12.5 U/kg - Group 2 Lamazym 25 U/kg - Group 3 Lamazym 50 U/kg - Group 4 Lamazym 100 U/kg - Group 5
    Number of subjects analysed
    2
    2
    2
    2
    2
    Units: mmol/L
        arithmetic mean (standard deviation)
    140.5 ( 0.7 )
    140.5 ( 0.7 )
    139 ( 0 )
    138.5 ( 0.7 )
    139 ( 2.1 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From Visit 2 (baseline) to Visit 12
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    13.0
    Reporting groups
    Reporting group title
    Lamazym 6.25 U/kg - Group 1
    Reporting group description
    		 A fixed dose regimen was chosen (6.25, 12.5, 25, 50 or 100 U/kg). The dose was determined after an evaluation at baseline and on the basis of which group the patient was stratified to (from 1-5). Each patient was to receive an infusion once a week. The number of infusions was dependant on the group number the patient was stratified to hence the onset of the first infusion for each patient. Infusions were administered weekly commencing with group 1, where patients received their first dose at Day 0 (Visit 3). One week later (7 days ± 2 days) group 2 received their first infusion (Visit 3) whereas group 1 received their second dose (Visit 4) and so on until group 5 who would have only one fusion before entering phase IIa. Group 1 was expected to receive a total of 5 doses, group 2, 4 doses and so on until group 5, which was expected to receive only 1 dose.

    Reporting group title
    Lamazym 12.5 U/kg - Group 2
    Reporting group description
    		 A fixed dose regimen was chosen (6.25, 12.5, 25, 50 or 100 U/kg). The dose was determined after an evaluation at baseline and on the basis of which group the patient was stratified to (from 1-5). Each patient was to receive an infusion once a week. The number of infusions was dependant on the group number the patient was stratified to hence the onset of the first infusion for each patient. Infusions were administered weekly commencing with group 1, where patients received their first dose at Day 0 (Visit 3). One week later (7 days ± 2 days) group 2 received their first infusion (Visit 3) whereas group 1 received their second dose (Visit 4) and so on until group 5 who would have only one fusion before entering phase IIa.

    Reporting group title
    Lamazym 25 U/kg - Group 3
    Reporting group description
    		 A fixed dose regimen was chosen (6.25, 12.5, 25, 50 or 100 U/kg). The dose was determined after an evaluation at baseline and on the basis of which group the patient was stratified to (from 1-5). Each patient was to receive an infusion once a week. The number of infusions was dependant on the group number the patient was stratified to hence the onset of the first infusion for each patient. Infusions were administered weekly commencing with group 1, where patients received their first dose at Day 0 (Visit 3). One week later (7 days ± 2 days) group 2 received their first infusion (Visit 3) whereas group 1 received their second dose (Visit 4) and so on until group 5 who would have only one fusion before entering phase IIa.

    Reporting group title
    Lamazym 50 U/kg - Group 4
    Reporting group description
    		 A fixed dose regimen was chosen (6.25, 12.5, 25, 50 or 100 U/kg). The dose was determined after an evaluation at baseline and on the basis of which group the patient was stratified to (from 1-5). Each patient was to receive an infusion once a week. The number of infusions was dependant on the group number the patient was stratified to hence the onset of the first infusion for each patient. Infusions were administered weekly commencing with group 1, where patients received their first dose at Day 0 (Visit 3). One week later (7 days ± 2 days) group 2 received their first infusion (Visit 3) whereas group 1 received their second dose (Visit 4) and so on until group 5 who would have only one fusion before entering phase IIa.

    Reporting group title
    Lamazym 100 U/kg - Group 5
    Reporting group description
    		 A fixed dose regimen was chosen (6.25, 12.5, 25, 50 or 100 U/kg). The dose was determined after an evaluation at baseline and on the basis of which group the patient was stratified to (from 1-5). Each patient was to receive an infusion once a week. The number of infusions was dependant on the group number the patient was stratified to hence the onset of the first infusion for each patient. Infusions were administered weekly commencing with group 1, where patients received their first dose at Day 0 (Visit 3). One week later (7 days ± 2 days) group 2 received their first infusion (Visit 3) whereas group 1 received their second dose (Visit 4) and so on until group 5 who would have only one fusion before entering phase IIa.

    Serious adverse events
    		 Lamazym 6.25 U/kg - Group 1 Lamazym 12.5 U/kg - Group 2 Lamazym 25 U/kg - Group 3 Lamazym 50 U/kg - Group 4 Lamazym 100 U/kg - Group 5
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Lamazym 6.25 U/kg - Group 1 Lamazym 12.5 U/kg - Group 2 Lamazym 25 U/kg - Group 3 Lamazym 50 U/kg - Group 4 Lamazym 100 U/kg - Group 5
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2 / 2 (100.00%)
    1 / 2 (50.00%)
    1 / 2 (50.00%)
    1 / 2 (50.00%)
    1 / 2 (50.00%)
    Investigations
    Urine analysis abnormal
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    1 / 2 (50.00%)
    1 / 2 (50.00%)
    1 / 2 (50.00%)
         occurrences all number
    0
    0
    1
    1
    1
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 2 (50.00%)
    0 / 2 (0.00%)
    1 / 2 (50.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    Reflux gastritis
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    1 / 2 (50.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Vomiting
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Infections and infestations
    Skin infection
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 2 (50.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    15 Oct 2010
    • Addition of a pregnancy test in the post-menarchal adolescents women at inclusion and throughout the study as requested by the IEC. • Reduction of the infusion rate from 1.5 mg/min to 0.5 mg/min as requested by the SC. • Addition of an ECG taken immediately after the infusion stop, as requested by the SC.

    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.
    NO limitations or caveats are applicable to this summary.
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    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
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