Clinical Trial Results:
In vivo molecular imaging of angiogenesis after VEGF-D gene therapy
Summary
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EudraCT number |
2018-001494-24 |
Trial protocol |
DK |
Global end of trial date |
01 Jun 2023
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Results information
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Results version number |
v1(current) |
This version publication date |
16 Dec 2024
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First version publication date |
16 Dec 2024
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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 |
AK2015-10
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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 |
Rigshospitalet
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Sponsor organisation address |
Blegdamsvej 9, Copenhagen, Denmark, 2100
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Public contact |
Rasmus Ripa, Rigshospitalet, Department of Clinical Physiology, Nuclear Medicine and PET, 45 35454011, rasmus.ripa@regionh.dk
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Scientific contact |
Rasmus Ripa, Rigshospitalet, Department of Clinical Physiology, Nuclear Medicine and PET, 45 35454011, rasmus.ripa@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 |
26 Sep 2024
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
01 Jun 2023
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Global end of trial reached? |
Yes
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Global end of trial date |
01 Jun 2023
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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 use 68Ga-NODAGA-E[c(RGDyK)]2 PET/CT scans as a tool to image myocardial angiogenesis
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Protection of trial subjects |
The study investigated a new i.v. radiotracer for detecting angiogenesis. There were no discomfort or pain associated with the study of the new tracer.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
05 Mar 2020
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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 |
Denmark: 16
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Worldwide total number of subjects |
16
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EEA total number of subjects |
16
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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) |
8
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From 65 to 84 years |
8
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85 years and over |
0
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Recruitment
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Recruitment details |
The study population was recruited at a single center in Copenhagen, Denmark from March 2020 until October 2022. | |||||||||||||||||||||
Pre-assignment
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Screening details |
All participants in the ReGenHeart study (2017-000789-31) recruited in Denmark were screened for inclusion. | |||||||||||||||||||||
Period 1
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Period 1 title |
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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Are arms mutually exclusive |
Yes
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Arm title
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VEGF treatment | |||||||||||||||||||||
Arm description |
- | |||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||
Investigational medicinal product name |
68Ga-NODAGA-E[c(RGDyK)]2
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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 |
At the scan the patient were injected with ~200 MBq of 68Ga-NODAGA-E[c(RGDyK)]2
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Arm title
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Control | |||||||||||||||||||||
Arm description |
- | |||||||||||||||||||||
Arm type |
Placebo | |||||||||||||||||||||
Investigational medicinal product name |
68Ga-NODAGA-E[c(RGDyK)]2
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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 |
At the scan the patient were injected with ~200 MBq of 68Ga-NODAGA-E[c(RGDyK)]2
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Baseline characteristics reporting groups
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Reporting group title |
VEGF treatment
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Control
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
VEGF treatment
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Reporting group description |
- | ||
Reporting group title |
Control
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Reporting group description |
- |
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End point title |
Cardiac 68Ga-RGD uptake | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
From baseline to 6 months after VEGF treatment
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Statistical analysis title |
Primary endpoint | ||||||||||||
Comparison groups |
VEGF treatment v Control
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Number of subjects included in analysis |
12
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
= 0.4 | ||||||||||||
Method |
t-test, 2-sided | ||||||||||||
Confidence interval |
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Adverse events information
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Timeframe for reporting adverse events |
All participants were monitored 24 hours after injection of the radiotracer for adverse events. In additon, participants were asked about potential adverse events occuring in the period between the 3 scans (3-4 months)
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
10
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Reporting groups
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Reporting group title |
All included
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Reporting group description |
All subjects treated with at least one dose of IMP | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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. | |||
It was not possible to include the planned number of subjects. |