Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   40995   clinical trials with a EudraCT protocol, of which   6701   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A randomized phase II pilot - trial, examining the safety, pharmacokinetics, pharmacodynamics, and clinical efficacy of escalating doses of alteplase in patients with acute lung injury / acute respiratory distress syndrome / severe pneumonia

    Summary
    EudraCT number
    2010-024377-40
    Trial protocol
    AT  
    Global end of trial date
    24 Apr 2017

    Results information
    Results version number
    v1(current)
    This version publication date
    26 Oct 2019
    First version publication date
    26 Oct 2019
    Other versions

    Trial information

    Close Top of page
    Trial identification
    Sponsor protocol code
    TPA-ALI
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Medizinische Universität Wien, UniKlinik für Klinische Pharmakologie
    Sponsor organisation address
    Währingergürtel 18-20, Vienna, Austria, 1090
    Public contact
    Bernd Jilma, UniKlinik für Klinische Pharmakologie, +43 14040029810, bernd.jilma@meduniwien.ac.at
    Scientific contact
    Bernd Jilma, UniKlinik für Klinische Pharmakologie, +43 14040029810, bernd.jilma@meduniwien.ac.at
    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
    24 Apr 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    24 Apr 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Apr 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To investigate safety, pharmacokinetics, pharmacodynamics, and clinical efficacy of escalating doses of alteplase in patients with acute lung injury / acute respiratory distress syndrome / severe pneumonia
    Protection of trial subjects
    No other specific measures than the standard measures of good clinical and scientific practice were put in place for the protection of subjects.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    06 May 2011
    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
    Austria: 1
    Worldwide total number of subjects
    1
    EEA total number of subjects
    1
    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)
    1
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    Close Top of page
    Recruitment
    Recruitment details
    1 patient was included in this trial on February 7th 2012. This was a single center study which was performed at the Medical University of Vienna, Austria.

    Pre-assignment
    Screening details
    One patient was screened, who was all successfully included in the trial according to the applicable in- and exclusion criteria.

    Pre-assignment period milestones
    Number of subjects started
    1
    Number of subjects completed
    1

    Period 1
    Period 1 title
    Main Trial (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Carer
    Blinding implementation details
    Placebos and Verum infusions were not distinguishable from each other by their physicochemical properties. An unblinded study nurse under supervision of an unblinded physician who had access to treatment allocation codes prepared study drugs. They were not otherwise involved in conducting the trial.

    Arms
    Arm title
    rTPA
    Arm description
    Verum arm
    Arm type
    Experimental

    Investigational medicinal product name
    Alteplase
    Investigational medicinal product code
    Other name
    Actilyse
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    0.5 mg/kg or 1.0 mg/kg, over 2 hours continuous i.v.

    Number of subjects in period 1
    rTPA
    Started
    1
    Completed
    1

    Baseline characteristics

    Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    rTPA
    Reporting group description
    Verum arm

    Reporting group values
    rTPA Total
    Number of subjects
    1 1
    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)
    1 1
        From 65-84 years
    0 0
        85 years and over
    0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    54 ± 0 -
    Gender categorical
    Units: Subjects
        Female
    0 0
        Male
    1 1
    Subject analysis sets

    Subject analysis set title
    Subject analysis
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Only one patient was included.

    Subject analysis sets values
    Subject analysis
    Number of subjects
    1
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    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)
    1
        From 65-84 years
    0
        85 years and over
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    54 ± 0
    Gender categorical
    Units: Subjects
        Female
    0
        Male
    1

    End points

    Close Top of page
    End points reporting groups
    Reporting group title
    rTPA
    Reporting group description
    Verum arm

    Subject analysis set title
    Subject analysis
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Only one patient was included.

    Primary: PaO2/FiO2 ratio

    Close Top of page
    End point title
    PaO2/FiO2 ratio
    End point description
    End point type
    Primary
    End point timeframe
    ratio before and at the end of infusion, at 4, 6, 24, 30, 48, 54, and 72h after the start of the infusion
    End point values
    rTPA Subject analysis
    Number of subjects analysed
    1
    1
    Units: ratio
        <150
    1
    1
        >150
    0
    0
    Statistical analysis title
    primary Analysis
    Statistical analysis description
    Kruskal-Wallis ANOVA
    Comparison groups
    rTPA v Subject analysis
    Number of subjects included in analysis
    2
    Analysis specification
    Pre-specified
    Analysis type
    equivalence
    P-value
    ≤ 0.05
    Method
    Kruskal-wallis
    Confidence interval

    Adverse events

    Close Top of page
    Adverse events information [1]
    Timeframe for reporting adverse events
    Screening until follow up.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    ICD
    Dictionary version
    10
    Reporting groups
    Reporting group title
    rTPA
    Reporting group description
    -

    Serious adverse events
    rTPA
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 1 (0.00%)
         number of deaths (all causes)
    1
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    rTPA
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 1 (0.00%)
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: Only one patient was included in the trial.

    More information

    Close Top of page

    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
    For support, visit the EMA Service Desk , log in using your EMA account and open a ticket specifying "EU CTR" in your request.
    If you do not have an account, please visit the EMA Account management page page click on "Create an EMA account" and follow the instructions.
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2021 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA