Clinical Trial Results:
GLP-1 ANALOGS FOR NEUROPROTECTION AFTER OUT-OF-HOSPITAL CARDIAC ARREST, A RANDOMIZED CLINICAL TRIAL
Summary
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EudraCT number |
2013-004311-45 |
Trial protocol |
DK |
Global end of trial date |
01 Jun 2016
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Results information
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Results version number |
v1(current) |
This version publication date |
30 Nov 2021
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First version publication date |
30 Nov 2021
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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 |
2013-PharmaCA-001
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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 |
Copenhagen University Hospital Rigshospitalet
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Sponsor organisation address |
9 Blegdamsvej, Copenhagen, Denmark, 2100
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Public contact |
Cardiology Intensive Care Unit B214, Copenhagen University Hospital Rigshospitalet, Department of Cardiology B 2143, 45 35452143, jesper.kjaergaard.01@regionh.dk
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Scientific contact |
Cardiology Intensive Care Unit B214, Copenhagen University Hospital Rigshospitalet, Department of Cardiology B 2143, 45 35452143, jesper.kjaergaard.01@regionh.dk
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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 |
20 Dec 2016
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
17 Nov 2015
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Global end of trial reached? |
Yes
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Global end of trial date |
01 Jun 2016
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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 reduce to degree of post anoxic brain injury following resuscitation cardiac arrest, defined by a combined endpoint of efficacy (area under the Neuron Specific Enolasis -curve) and a feasibility defined as rapid initiation of study drug infusion
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Protection of trial subjects |
Was applied according to the protocol
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
13 Jan 2014
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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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 |
Denmark: 120
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Worldwide total number of subjects |
120
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EEA total number of subjects |
120
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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) |
20
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From 65 to 84 years |
80
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85 years and over |
20
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Recruitment
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Recruitment details |
Recruitment finalaized | ||||||
Pre-assignment
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Screening details |
Screening patients admitted after resuscitated cardiac arrest | ||||||
Pre-assignment period milestones
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Number of subjects started |
120 | ||||||
Number of subjects completed |
120 | ||||||
Period 1
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Period 1 title |
Recruitment (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 |
Investigator, Monitor, Subject, Data analyst, Carer, Assessor | ||||||
Arms
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Arm title
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GLP-1 analoug | ||||||
Arm description |
Byetta | ||||||
Arm type |
Experimental | ||||||
Investigational medicinal product name |
Byetta
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for injection/infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
17.4 mcg of exenatide
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Baseline characteristics reporting groups
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Reporting group title |
GLP-1 analoug
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Reporting group description |
Byetta | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Subject analysis sets
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Subject analysis set title |
final
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Subject analysis set type |
Full analysis | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
Alle subjects
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End points reporting groups
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Reporting group title |
GLP-1 analoug
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Reporting group description |
Byetta | ||
Subject analysis set title |
final
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
Alle subjects
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End point title |
Area Under the NSE curve | ||||||||||||
End point description |
Area under the NSE curve
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End point type |
Primary
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End point timeframe |
48 hours
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Notes [1] - Correct |
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Statistical analysis title |
Primary | ||||||||||||
Comparison groups |
GLP-1 analoug v final
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Number of subjects included in analysis |
236
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
= 0.05 | ||||||||||||
Method |
t-test, 2-sided | ||||||||||||
Parameter type |
Mean difference (final values) | ||||||||||||
Point estimate |
1307
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
804 | ||||||||||||
upper limit |
2093 | ||||||||||||
Variability estimate |
Standard error of the mean
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Adverse events information [1]
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Timeframe for reporting adverse events |
3 months
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Assessment type |
Systematic | ||
Dictionary used for adverse event reporting
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Dictionary name |
CRF | ||
Dictionary version |
1
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Frequency threshold for reporting non-serious adverse events: 1% | |||
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: Done |
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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 | |||
Online references |
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http://www.ncbi.nlm.nih.gov/pubmed/27838646 |