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
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EudraCT number |
2010-024377-40 |
Trial protocol |
AT |
Global end of trial date |
24 Apr 2017
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Results information
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Results version number |
v1(current) |
This version publication date |
26 Oct 2019
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First version publication date |
26 Oct 2019
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
TPA-ALI
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Medizinische Universität Wien, UniKlinik für Klinische Pharmakologie
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Sponsor organisation address |
Währingergürtel 18-20, Vienna, Austria, 1090
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Public contact |
Bernd Jilma, UniKlinik für Klinische Pharmakologie, +43 14040029810, bernd.jilma@meduniwien.ac.at
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Scientific contact |
Bernd Jilma, UniKlinik für Klinische Pharmakologie, +43 14040029810, bernd.jilma@meduniwien.ac.at
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
24 Apr 2018
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
24 Apr 2017
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Global end of trial reached? |
Yes
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Global end of trial date |
24 Apr 2017
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Was the trial ended prematurely? |
No
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General information about the trial
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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
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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.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
06 May 2011
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Austria: 1
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Worldwide total number of subjects |
1
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EEA total number of subjects |
1
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
1
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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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
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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
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Number of subjects started |
1 | ||||||
Number of subjects completed |
1 | ||||||
Period 1
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Period 1 title |
Main Trial (overall period)
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Is this the baseline period? |
Yes | ||||||
Allocation method |
Randomised - controlled
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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.
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Arms
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Arm title
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rTPA | ||||||
Arm description |
Verum arm | ||||||
Arm type |
Experimental | ||||||
Investigational medicinal product name |
Alteplase
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Investigational medicinal product code |
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Other name |
Actilyse
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Pharmaceutical forms |
Infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
0.5 mg/kg or 1.0 mg/kg, over 2 hours continuous i.v.
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Baseline characteristics reporting groups
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Reporting group title |
rTPA
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Reporting group description |
Verum arm | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Subject analysis sets
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Subject analysis set title |
Subject analysis
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Subject analysis set type |
Full analysis | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
Only one patient was included.
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End points reporting groups
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Reporting group title |
rTPA
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Reporting group description |
Verum arm | ||
Subject analysis set title |
Subject analysis
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
Only one patient was included.
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End point title |
PaO2/FiO2 ratio | |||||||||||||||
End point description |
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End point type |
Primary
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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
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Statistical analysis title |
primary Analysis | |||||||||||||||
Statistical analysis description |
Kruskal-Wallis ANOVA
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Comparison groups |
rTPA v Subject analysis
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Number of subjects included in analysis |
2
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Analysis specification |
Pre-specified
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Analysis type |
equivalence | |||||||||||||||
P-value |
≤ 0.05 | |||||||||||||||
Method |
Kruskal-wallis | |||||||||||||||
Confidence interval |
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Adverse events information [1]
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Timeframe for reporting adverse events |
Screening until follow up.
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Assessment type |
Systematic | ||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
ICD | ||||||||||
Dictionary version |
10
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Reporting groups
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Reporting group title |
rTPA
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Reporting group description |
- | ||||||||||
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Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||
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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. |
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |