Clinical Trial Results:
Open-label, multi-center study to evaluate the safety, efficacy, and plasma gadolinium concentrations after an intravenous injection of 0.1 mL/kg body weight Eovist/Primovist for enhanced magnetic resonance imaging of the liver in children 0 to 2 months of age
Due to the EudraCT – Results system being out of service between 31 July 2015 and 12 January 2016, these results have been published in compliance with revised timelines.
Summary
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EudraCT number |
2012-000952-32 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
11 Aug 2015
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Results information
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Results version number |
v1 |
This version publication date |
06 Jul 2016
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First version publication date |
06 Jul 2016
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Other versions |
v2 |
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 |
BAY86-4873/16078
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT02084628 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Bayer HealthCare AG
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Sponsor organisation address |
Kaiser-Wilhelm-Allee, D-51368 Leverkusen, Germany,
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Public contact |
Therapeutic Area Head, Bayer HealthCare AG, clinical-trials-contact@bayerhealthcare.com
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Scientific contact |
Therapeutic Area Head, Bayer HealthCare AG, clinical-trials-contact@bayerhealthcare.com
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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? |
Yes
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
11 Aug 2015
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
11 Aug 2015
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Was the trial ended prematurely? |
Yes
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General information about the trial
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Main objective of the trial |
The objectives of this study were to evaluate the safety, efficacy (imaging data), and plasma gadolinium concentrations after administration of Eovist/Primovist in pediatric subjects 0 to 2 months of age with known or suspected hepatobiliary pathology who were undergoing contrast-enhanced magnetic resonance imaging (MRI) of the liver.
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Protection of trial subjects |
The conduct of this clinical study met all local legal and regulatory requirements. The study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and the International Conference on Harmonization guideline E6: Good Clinical Practice. Before entering the study, the informed consent form was read by and explained to their legally authorized representative. Participating subject's legally authorized representative signed informed consent form and could withdraw from the study at any time without any disadvantage and without having to provide a reason for this decision. Only investigators qualified by training and experience were selected as appropriate experts to investigate the study drug.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
13 Feb 2015
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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 |
United States: 1
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Worldwide total number of subjects |
1
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EEA total number of subjects |
0
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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) |
1
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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) |
0
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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 |
Study was conducted at 9 centres in United States of America (USA) and only one subject was recruited in one centre, between 13 February 2015 (first subject first visit) and 11 August 2015 (Last subject last visit). | ||||||
Pre-assignment
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Screening details |
One subject was enrolled in the study. | ||||||
Period 1
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Period 1 title |
Overall study (overall period)
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Is this the baseline period? |
Yes | ||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||
Arms
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Arm title
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Eovist/Primovist (BAY86-4873) | ||||||
Arm description |
Subjects to receive single dose of Eovist/Primovist as a manual injection at a dose of 0.1 milliliter per kilogram (mL/kg) body weight (BW) (0.025 millimole [mmol]/kg BW), followed by a flush of at least 5 mL saline (sodium chloride 0.9 percent [%] solution) manually. | ||||||
Arm type |
Experimental | ||||||
Investigational medicinal product name |
Eovist
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Investigational medicinal product code |
BAY86-4873
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Other name |
Primovist
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Pharmaceutical forms |
Injection
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Routes of administration |
Intravenous use
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Dosage and administration details |
Subject recieved Eovist/Primovist injection at a dose of 0.1 mL/kg BW (0.025 mmol/kg BW), followed by a flush of at least 5 mL saline manually.
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Baseline characteristics reporting groups
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Reporting group title |
Eovist/Primovist (BAY86-4873)
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Reporting group description |
Subjects to receive single dose of Eovist/Primovist as a manual injection at a dose of 0.1 milliliter per kilogram (mL/kg) body weight (BW) (0.025 millimole [mmol]/kg BW), followed by a flush of at least 5 mL saline (sodium chloride 0.9 percent [%] solution) manually. | ||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Eovist/Primovist (BAY86-4873)
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Reporting group description |
Subjects to receive single dose of Eovist/Primovist as a manual injection at a dose of 0.1 milliliter per kilogram (mL/kg) body weight (BW) (0.025 millimole [mmol]/kg BW), followed by a flush of at least 5 mL saline (sodium chloride 0.9 percent [%] solution) manually. |
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End point title |
Number of Subjects With Additional Diagnostic Information From Combined (Pre-contrast And Post-contrast) Images Compared With Pre-contrast Images [1] | ||||||
End point description |
Additional diagnostic information such as better delineation of the border of the lesion, better definition of the internal morphology of the lesion, better characterization of the lesion, better definition of the location of the lesion, better assessment of the communication of the lesion with respect to the biliary system obtained from the combined magnetic resonance (MR) images compared with pre-contrast MR images. Number of subjects with additional diagnostic information were recorded and analyzed.
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End point type |
Primary
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End point timeframe |
Images were taken pre-injection and post-injection (within about 15 minutes)
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Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: In this study only one subject was enrolled and hence, inferential statistical analysis was not performed. |
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No statistical analyses for this end point |
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End point title |
Number of Subjects With Adverse Events [2] | ||||||
End point description |
An adverse event (AE) was any untoward medical occurrence that is, any unfavorable and unintended sign (including abnormal laboratory findings), symptom or disease in a subject or clinical investigation subject after providing written informed consent for participation in the study.
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End point type |
Primary
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End point timeframe |
From the signing of the informed consent form until the 6 month post MRI follow-up
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Notes [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: In this study only one subject was enrolled and hence, inferential statistical analysis was not performed. |
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No statistical analyses for this end point |
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End point title |
Number of Subjects With Serious Adverse Events [3] | ||||||
End point description |
An serious adverse events (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
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End point type |
Primary
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End point timeframe |
From the signing of the informed consent form until the 6 month post MRI follow-up
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Notes [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: In this study only one subject was enrolled and hence, inferential statistical analysis was not performed. |
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No statistical analyses for this end point |
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End point title |
Number of Lesions Detected for the Pre-contrast Images | ||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Images were taken pre-injection
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No statistical analyses for this end point |
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End point title |
Number of Lesions Detected for the Combined Images | ||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Images were taken pre-injection and post-injection (within about 15 minutes)
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No statistical analyses for this end point |
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End point title |
Contrast Enhancement of the Liver for the Combined Images Assessed by yes or no Question | ||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Images were taken pre-injection and post-injection (within about 15 minutes)
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No statistical analyses for this end point |
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End point title |
Contrast Enhancement of the Biliary System for the Combined Images Assessed by yes or no Question | ||||||||||
End point description |
Biliary system included
a. Gall bladder
b. Cystic duct
c. Common bile duct
d. Right main bile duct
e. Left main bile duct
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End point type |
Secondary
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End point timeframe |
Images were taken pre-injection and post-injection (within about 15 minutes)
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No statistical analyses for this end point |
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End point title |
Visualization of the Biliary System for the Pre-contrast and Combined Images Assessed by yes or no Question | ||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Images were taken pre-injection and post-injection (within about 15 minutes)
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No statistical analyses for this end point |
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End point title |
Change in Diagnosis for the Combined Images Compared With Pre-contrast Images | ||||||
End point description |
Diagnosis based on the pre-contrast images will be indicated. If there is a change in the diagnosis based on the combined images, then the combined images diagnosis will be recorded.
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End point type |
Secondary
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End point timeframe |
Images were taken pre-injection and post-injection (within about 15 minutes)
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No statistical analyses for this end point |
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End point title |
Diagnostic Confidence for the Pre-contrast and Combined Images Assessed by yes or no Question | ||||||||||||||||||
End point description |
Diagnostic confidence was classified as not confident (No), confident (Yes), very confident (Yes).
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End point type |
Secondary
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End point timeframe |
Images were taken pre-injection and post-injection (within about 15 minutes)
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No statistical analyses for this end point |
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Adverse events information [1]
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Timeframe for reporting adverse events |
From the signing of the informed consent form until the 6 month post MRI follow-up
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Assessment type |
Non-systematic | ||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||
Dictionary version |
18.1
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Reporting groups
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Reporting group title |
Eovist/Primovist (BAY86-4873)
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Reporting group description |
Subject recieved Eovist/Primovist injection at a dose of 0.1 mL/kg BW (0.025 mmol/kg BW), followed by a flush of at least 5 mL saline manually. | ||||||||||
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Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||
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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: In this study only one subject was enrolled, received treatment and completed the study. There were no non-serious adverse event reported for this subject during the study. |
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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. | |||
Primarily based on study 13729 along with supporting data the FDA revised Eovist labeling to remove any age restriction from indication and decided that there are no further pediatric data requested. Consequently, study was discontinued. |