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    Clinical Trial Results:
    Pilot study to investigate the clinical effect of orally inhaled AP301 on treatment of primary graft dysfunction (PGD) in mechanically ventilated patients after primary lung transplantation

    Summary
    EudraCT number
    		 2013-000716-21
    Trial protocol
    		 AT  
    Global end of trial date
    18 Mar 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    06 Aug 2016
    First version publication date
    06 Aug 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    AP301-III-001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Apeptico GmbH
    Sponsor organisation address
    Mariahilfer Straße 136, Vienna, Austria, 1150
    Public contact
    Head of Company, Apeptico Forschung und Entwicklung GmbH, 0043 6641432919, b.fischer@apeptico.com
    Scientific contact
    Head of Company, Apeptico Forschung und Entwicklung GmbH, 0043 6641432919, b.fischer@apeptico.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
    02 Nov 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    18 Mar 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    18 Mar 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Primary objective was to assess the clinical effect of orally inhaled AP301 on treatment of primary graft dysfunction (PGD) according to ISHLT (International Society for Heart and Lung Transplantation) criteria in patients after primary LuTX in comparison to placebo. Secondary Objectives were to -evaluate recipients mortality at 30 days after transplantation (%) -duration of intubation -requirement of mechanical ventilation -length of ICU stay -incidence of acute rejections -freedom of chronic lung allograft dysfunction -graft survival within 30 days -local and systematic safety and tolerability of AP 301
    Protection of trial subjects
    To guarantee the highest possible protection of subjects, safety measures were put in place throughout Screening, Treatment and Follow up. Withdrawal rules including safety endpoints were defined carefully. Specific safety measures concerned : Administration of AP301 AP301 or any other ingredients of the IMP can potentially cause hypersensitivity reactions, including serious anaphylactic/anaphylactoid reactions . Local ICU staff had proven expertise in rapid diagnoses and treatment of these disease patterns. The Staff was advised to withdraw any subject, who showes corresponding symptoms immediately from this study. Resuscitation measures including airway management, administration of large volumes of intravenous fluids and 1:1000 adrenalin solution for i.m. injection were all time and without delay enforceable at ICU. The subject's protection from dose dependent side effects had crucial importance.For the subject’s safety, selection oft he administered dose was based on prior scientific evidence about pharmacokinetics- and dynamics of AP301 and influencing factors of the nebulizing process. Prior to site initiation, all site staff had received hands- on training regarding the dosage regimen and handling of the nebulizer unit. Medical and Safety Assessment During screening, Inclusion/Exclusion criteria, medical history, physical examination, vital signs and pregnancy test (if applicable) were evaluated. During treatment, vital signs were assessed daily. On EOT visit, physical examination was repeated. Monitoring of ventilation parameters and evaluation of PGD score, CXR and EVLW was carried out daily during treatment in accordance to national LuTX guidelines. Special Safety Assessment including Hematology, Clinical Chemistry and blood gasses was carried out daily during screening and treatment. As many patients were multimorbid,the need for change in comitant medication was frequently evaluated and, if necessary, conducted by qualified staff
    Background therapy
    		 As this study has been performed with ICU patients under severe health conditions, a high number of different concomitant medications have been administered. Apart from cancer Therapy (chemotherapy or biological), any other medically indicated medications were allowed, including immunsupressive therapies. Modifications of concomitant treatment during the clinical investigation were allowed as necessary and were documented in the patients record by staff with proven qualification.
    Evidence for comparator
    		 Treatment of PGD is supportive and in severe cases may include lung-protective ventilation strategies , inhaled nitric oxide and temporary ECMO support.Retransplantation represents a last resort (Fuehner, Grer, Welte&Gottlieb, 2012) In cases of established PGD, NO-therapy seems to be useful for improving gas exchange it. Nevertheless, there are currently no studies supporting its use for ventilatory or survival benefit. Regarding prophylactic inhaled NO there are currently no randomised controlled studies that demonstrate a reduction in morbidity( time to extubation, length of ICU stay or hospital stay and mortality ( Tavare& Tsakok, 2011) If compared to other investigational medicinal products, AP301 represents a new molecular type and new concept for prevention and treatment of pulmonary permeability edema and prevention of ischemia - reperfusion injury. The test compound- for the first time - represents a molecule that directly improves alveolar fluid clearance and that restores the endothelial barrier function of the micro-capillary and alveolar tissue.AP301 is expected to therapeutically treat primary graft dysfunction by reducing leakage fluids from capillaries in the lungs, by activating alveolar edema clearance and by restoring the endothelial barrier function. The therapeutic potential of AP301 in PGD has been demonstrated in preclinical studies in rats (Hemacher et al, 2010). In another preclinical transplantation study in pigs at the department of Thoracic Surgery of the Medical department of the Medical University of Vienna, it was demonstrated that inhalative application of nebulized AP301 during an extracorporal mode simulating LUTX to severely pre-damaged donor lungs significantly improved the gas exchange compared to placebo treatment(Aigner et al, 2013).Also, the therapeutic potential of AP301 to treat pulmonary permeability edema has been highlighted in Critical Care medicine (Matthay, 2008) and Vascular Pharmacology (Black,2010)
    Actual start date of recruitment
    20 Jun 2013
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Austria: 20
    Worldwide total number of subjects
    20
    EEA total number of subjects
    20
    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)
    20
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Start date: 20.6.2013 Trial country: Austria Planned number of subjects: 20 Actual number of subjects enrolled: 20 The subjects were recruited from the AKH 's waiting list for primary single or double LuTX

    Pre-assignment
    Screening details
    		 Study screening procedures included the following: Inclusion/Exclusion criteria, demographic data, physical examination, vital signs, medical history and concomitant diseases, clinical laboratory tests and pregnancy test for females.

    Pre-assignment period milestones
    Number of subjects started
    		 20
    Number of subjects completed
    		 20

    Period 1
    Period 1 title
    Treatment-Period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 AP301
    Arm description
    		 Subjects randomized to AP301 administration
    Arm type
    		 Experimental

    Investigational medicinal product name
    AP301
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for nebuliser solution
    Routes of administration
    Inhalation use
    Dosage and administration details
    The IMP was reconstituted in water for injection to a final concentration of 25mg/ml.After randomization patients received 5ml of the study drug according to treatment allocation via endotracheal nebulisation every 12 hours for a maximum of 7 days using an Aerob Solo nebulizer (Aerogen, Galway, Ireland).This equates to a nebulizer filling dose of 125 mg AP301 peptide. This filling dose corresponds with an orally delivered dose of 87,6 mg AP301. The timepoints for inhalations were 9.00 a.m. (+/-60 min) and 9.00 p.m. (+/-60 min).After diagnosis of PGD , study drug was administered immediately, if the interval for next regularly scheduled time point for administration would have exceeded more than three hours.

    Arm title
    		 PLACEBO
    Arm description
    		 Subjects randomized to Placebo administration
    Arm type
    		 Placebo

    Investigational medicinal product name
    0.9% Na-Cl Solution
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Inhalation use
    Dosage and administration details
    5 ml nebulizer filling dose was inhaled after endotracheally nebulization via device (Aeroneb® solo nebulizing system) every 12 hours for a total of 7 days or till day of extubation.

    Number of subjects in period 1
    		AP301 PLACEBO
    Started
    10
    10
    IMP adm. till extubation
    10
    10
    First administration of IMP
    10
    10
    Completed
    10
    10
    Period 2
    Period 2 title
    Follow-up Period
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 AP301
    Arm description
    		 Patients who had received AP301 in period 1
    Arm type
    		 Experimental

    Investigational medicinal product name
    AP301
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for nebuliser solution
    Routes of administration
    Inhalation use
    Dosage and administration details
    The IMP was reconstituted in water for injection to a final concentration of 25mg/ml.After randomization patients received 5ml of the study drug according to treatment allocation via endotracheal nebulisation every 12 hours for a maximum of 7 days using an Aerob Solo nebulizer (Aerogen, Galway, Ireland).This equates to a nebulizer filling dose of 125 mg AP301 peptide. This filling dose corresponds with an orally delivered dose of 87,6 mg AP301. The timepoints for inhalations were 9.00 a.m. (+/-60 min) and 9.00 p.m. (+/-60 min).After diagnosis of PGD , study drug was administered immediately, if the interval for next regularly scheduled time point for administration would have exceeded more than three hours.

    Arm title
    		 PLACEBO
    Arm description
    		 Patients who had received Placebo in period 1
    Arm type
    		 Placebo

    Investigational medicinal product name
    0.9% Na-Cl Solution
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Inhalation use
    Dosage and administration details
    Same dosage as IMP applied, 5ml NaCl solution for inhalation prepared

    Number of subjects in period 2
    		AP301 PLACEBO
    Started
    10
    10
    Interview 30 days after Transplantation
    10
    10
    Completed
    10
    10

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    AP301
    Reporting group description
    		 Subjects randomized to AP301 administration

    Reporting group title
    PLACEBO
    Reporting group description
    		 Subjects randomized to Placebo administration

    Reporting group values
    		 AP301 PLACEBO Total
    Number of subjects
    		 10 10 20
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 10 10 20
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 54.8 ( 13.02 ) 53.9 ( 5.67 ) -
    Gender categorical
    Units: Subjects
        Female
    		 4 5 9
        Male
    		 6 5 11
    Ethnic Origin
    Units: Subjects
        caucasian
    		 10 10 20
        others
    		 0 0 0
    Clinical examination, abnormal findings ( in addition to pulmonary findings)
    Units: Subjects
        Cardiovascular
    		 6 4 10
        Abdomen
    		 1 0 1
        HEENT
    		 1 1 2
        Neck
    		 0 0 0
        Neuro
    		 0 1 1
        Psych
    		 1 1 2
        Skeletal
    		 1 3 4
    Subject analysis sets

    Subject analysis set title
    ITT
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    This set includes subjects who where randomized and reveived at least one dose study drug

    Subject analysis set title
    PP
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    This set comprises all subjects who received study drug and did not viloate the protocol in a way that might affect the evaluation of the effect of the study drugs on the primary objective,i.e., without major protocol violations

    Subject analysis sets values
    		 ITT PP
    Number of subjects
    20
    20
    Age categorical
    Units: Subjects
        In utero
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
        Newborns (0-27 days)
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
        Children (2-11 years)
    0
    0
        Adolescents (12-17 years)
    0
    0
        Adults (18-64 years)
    20
    20
        From 65-84 years
    0
    0
        85 years and over
    0
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    ( )
    ( )
    Gender categorical
    Units: Subjects
        Female
    9
    9
        Male
    11
    11
    Ethnic Origin
    Units: Subjects
        caucasian
    20
    20
        others
    0
    0
    Clinical examination, abnormal findings ( in addition to pulmonary findings)
    Units: Subjects
        Cardiovascular
    10
    10
        Abdomen
    1
    1
        HEENT
    2
    2
        Neck
    0
    0
        Neuro
    1
    1
        Psych
    2
    2
        Skeletal
    4
    4

    End points

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    End points reporting groups
    Reporting group title
    AP301
    Reporting group description
    		 Subjects randomized to AP301 administration

    Reporting group title
    PLACEBO
    Reporting group description
    		 Subjects randomized to Placebo administration
    Reporting group title
    AP301
    Reporting group description
    		 Patients who had received AP301 in period 1

    Reporting group title
    PLACEBO
    Reporting group description
    		 Patients who had received Placebo in period 1

    Subject analysis set title
    ITT
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    This set includes subjects who where randomized and reveived at least one dose study drug

    Subject analysis set title
    PP
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    This set comprises all subjects who received study drug and did not viloate the protocol in a way that might affect the evaluation of the effect of the study drugs on the primary objective,i.e., without major protocol violations

    Primary: Change in Arterial blood oxygen tension (paO2)

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    End point title
    		 Change in Arterial blood oxygen tension (paO2)
    End point description
    PaO2 was assessed once daily during treatment period. It has been assessed using BGA measured on FiO2 =1.0 (=100%) and PEEP=5 for at least 10 minutes while still on mechanical ventilation.For the main comparison of the primary effiacy variable, means of the individual LOCF-PaO2between baseline and treatment day 3 were calculated.
    End point type
    Primary
    End point timeframe
    change of PAO2 between T0 (= time of PGD diagnosis) and day 3.
    End point values
    		 AP301 PLACEBO
    Number of subjects analysed
    10
    10
    Units: mmHg
        arithmetic mean (standard deviation)
    365.61 ( 90.94 )
    335.2 ( 42.27 )
    Statistical analysis title
    		 Statistical comparison of PaO2 data
    Comparison groups
    PLACEBO v AP301
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 ≤ 0.05
    Method
    		 t-test, 1-sided
    Confidence interval
    Statistical analysis title
    		 Statistical comparison of PaO2 data
    Comparison groups
    AP301 v PLACEBO
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.049 [1]
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [1] - no hypothesis tested and the power of 10 patients per group would only be 0.6.

    Secondary: Duration of intubation within 30 days after enrolment

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    End point title
    		 Duration of intubation within 30 days after enrolment
    End point description
    End point type
    Secondary
    End point timeframe
    Day of enrolment till day 30 after transplantation
    End point values
    		 AP301 PLACEBO AP301 PLACEBO
    Number of subjects analysed
    10
    10
    10
    10
    Units: days
        arithmetic mean (standard deviation)
    2 ( 0.82 )
    3.7 ( 1.95 )
    2 ( 0.82 )
    3.7 ( 1.95 )
    No statistical analyses for this end point

    Secondary: Recipient mortality 30 days after transplantation

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    End point title
    		 Recipient mortality 30 days after transplantation
    End point description
    death rate in the study population within 30 days after transplantation
    End point type
    Secondary
    End point timeframe
    Day 30 after transplantation
    End point values
    		 AP301 PLACEBO
    Number of subjects analysed
    10
    10
    Units: percent
        number (not applicable)
    0
    0
    No statistical analyses for this end point

    Secondary: Oxygenation index once daily until end of treatment or until extubation

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    End point title
    		 Oxygenation index once daily until end of treatment or until extubation
    End point description
    As few data after day 3 was available,only values till this day were put into consideration
    End point type
    Secondary
    End point timeframe
    day of enrolment till day 3
    End point values
    		 AP301 PLACEBO
    Number of subjects analysed
    10
    10
    Units: arbitrary units
    arithmetic mean (standard deviation)
        day1
    5.8 ( 3.36 )
    7.5 ( 2.92 )
        day2
    2.56 ( 0.73 )
    3 ( 0.47 )
        day3
    2 ( 0 )
    2.78 ( 0.97 )
    No statistical analyses for this end point

    Secondary: Requirement of mechanical ventilation within 30 days after enrolment

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    End point title
    		 Requirement of mechanical ventilation within 30 days after enrolment
    End point description
    End point type
    Secondary
    End point timeframe
    Within 30 days after enrolment
    End point values
    		 AP301 PLACEBO AP301 PLACEBO
    Number of subjects analysed
    10
    10
    10
    10
    Units: days
        arithmetic mean (standard deviation)
    2 ( 0.82 )
    3.7 ( 1.95 )
    2 ( 0.82 )
    3.7 ( 1.95 )
    No statistical analyses for this end point

    Secondary: Incidence of acute rejection

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    End point title
    		 Incidence of acute rejection
    End point description
    Percentage of subjects diagnosed with acute transplant rejection
    End point type
    Secondary
    End point timeframe
    Day of enrolment till follow-up interview
    End point values
    		 AP301 PLACEBO AP301 PLACEBO
    Number of subjects analysed
    10
    10
    10
    10
    Units: percent
        number (not applicable)
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Freedom of chronic lung allograft dysfunction (CLAD)

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    End point title
    		 Freedom of chronic lung allograft dysfunction (CLAD)
    End point description
    Percentage of subjects not diagnosed with chronic lung allograft dysfunction (CLAD)
    End point type
    Secondary
    End point timeframe
    Day of enrolment till follow up interview
    End point values
    		 AP301 PLACEBO AP301 PLACEBO
    Number of subjects analysed
    10
    10
    10
    10
    Units: percent
        number (not applicable)
    100
    100
    100
    100
    No statistical analyses for this end point

    Secondary: Graft survival within 30 days

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    End point title
    		 Graft survival within 30 days
    End point description
    Percentage of patients that have a functioning transplant at the end the given time period
    End point type
    Secondary
    End point timeframe
    Day of enrolment till follow -up Interview
    End point values
    		 AP301 PLACEBO AP301 PLACEBO
    Number of subjects analysed
    10
    10
    10
    10
    Units: percent
        number (not applicable)
    100
    100
    100
    100
    No statistical analyses for this end point

    Secondary: Length of ICU stay within 30 days after enrolment

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    End point title
    		 Length of ICU stay within 30 days after enrolment
    End point description
    End point type
    Secondary
    End point timeframe
    Treatment and Follow Up
    End point values
    		 AP301 PLACEBO AP301 PLACEBO
    Number of subjects analysed
    10
    10
    10
    10
    Units: days
        arithmetic mean (standard deviation)
    7.5 ( 3.14 )
    10.8 ( 8.65 )
    7.5 ( 3.14 )
    10.8 ( 8.65 )
    No statistical analyses for this end point

    Secondary: Overall survival within 30 days

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    End point title
    		 Overall survival within 30 days
    End point description
    percentage of patients that are alive at the end of the given time period
    End point type
    Secondary
    End point timeframe
    Day 30 after transplantation
    End point values
    		 AP301 PLACEBO AP301 PLACEBO
    Number of subjects analysed
    10
    10
    10
    10
    Units: percent
        number (not applicable)
    100
    100
    100
    100
    No statistical analyses for this end point

    Secondary: EVLW (measured with PiCCO technique)measured twice daily within 60 to 120 minutes after study drug administration until end of treatment

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    End point title
    		 EVLW (measured with PiCCO technique)measured twice daily within 60 to 120 minutes after study drug administration until end of treatment
    End point description
    End point type
    Secondary
    End point timeframe
    daily during treatment period
    End point values
    		 AP301 PLACEBO
    Number of subjects analysed
    10
    10
    Units: ml /KG
    arithmetic mean (standard deviation)
        Measurement baseline
    13.88 ( 5.28 )
    16 ( 6.29 )
        Measurement 1
    13.33 ( 6.5 )
    13.43 ( 2.44 )
        Measurement 2
    11 ( 3.11 )
    11.88 ( 6.92 )
        Measurement 3
    9.9 ( 3.68 )
    10 ( 2.79 )
        Measurement 4
    9 ( 3.12 )
    8.7 ( 1.7 )
        Measurement 5
    8.2 ( 0.84 )
    8.7 ( 2.21 )
        Measurement 6
    7.75 ( 1.71 )
    7.88 ( 2.9 )
        Measurement 7
    8 ( 1.41 )
    9 ( 3.92 )
        Measurement 8
    0 ( 0 )
    7.8 ( 3.56 )
        Measurement 9
    0 ( 0 )
    8 ( 2.55 )
        Measurement 10
    0 ( 0 )
    7.8 ( 2.59 )
        Measurement 11
    0 ( 0 )
    7.5 ( 2.38 )
        Measurement 12
    0 ( 0 )
    9.5 ( 2.12 )
        Measurement 13
    0 ( 0 )
    8 ( 0.71 )
        Measurement 14
    0 ( 0 )
    8 ( 1.41 )
    No statistical analyses for this end point

    Other pre-specified: Local and systematic safety and tolerability of AP301

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    End point title
    		 Local and systematic safety and tolerability of AP301
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Treatment and Follow Up
    End point values
    		 AP301 PLACEBO AP301 PLACEBO
    Number of subjects analysed
    10
    10
    10
    10
    Units: percent
    number (not applicable)
        Safety evaluation
    100
    100
    100
    100
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    treatment period and follow period
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    Ap301 group
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 Ap301 group Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Ap301 group Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2 / 10 (20.00%)
    2 / 10 (20.00%)
    Blood and lymphatic system disorders
    Leukopenia
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Total Atelektasis
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Hematome right lower lobe
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    Respiratory Acidosis
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Renal and urinary disorders
    Increasing BUN and creatinin level
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Increased creatinine level
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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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
    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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