Gadobutrol Pharmacokinetic and Safety Study in Pediatric Subjects Aged <2 Years (Term Newborn Infants to Toddlers 23 Months of Age Inclusive)
NCT ID: NCT01544166
Last Updated: 2020-12-16
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE1
44 participants
INTERVENTIONAL
2012-05-16
2013-11-28
Brief Summary
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A maximum total amount of approximately 5 ml of blood will be needed for these analyses which will be drawn within 2-3 days.
Gadobutrol is a contrast agent used for enhancement of Magnetic Resonance Imaging (MRI), potentially allowing better visibility of tissues in the body. Children aged under 2 years scheduled for a routine contrast-enhanced MRI examination of any body region may take part in this study, in which case they will receive gadobutrol as contrast agent intravenously at the standard dose of 0.1 mmol/kg (0.1 ml/Kg) of body weight. Only subjects without renal insufficiency of any intensity (i.e. estimated Glomerular Filtration Rate \<80% of age adjusted normal value calculated based on the Schwartz formula) will be included in the trial.
The duration of this study as a whole is around 1 year and the total number of children to be enrolled is 50. A child will be expected to take part in the study for around 7 days.
Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Overall study
Gadobutrol (Gadavist, BAY86-4875)
Single intravenous bolus injection of gadobutrol 0.1 mmol/kg BW in term newborns to infants \<2 years of age.
Interventions
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Gadobutrol (Gadavist, BAY86-4875)
Single intravenous bolus injection of gadobutrol 0.1 mmol/kg BW in term newborns to infants \<2 years of age.
Eligibility Criteria
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Inclusion Criteria
* Subject is scheduled to undergo routine gadolinium-enhanced MRI of any body region
Exclusion Criteria
* Any planned intervention during the study and up to 24 hours after gadobutrol injection (excluding lumbar puncture)
* Subjects who received or will receive any investigational product within 48 hours before gadobutrol injection or during study participation
* Subjects who received or will receive any other contrast agent within 48 hours prior to gadobutrol injection or up to 24 hours after gadobutrol injection
* Subjects with contraindication for MRI such as iron metal implants (e.g. aneurysm clips)
* History of anaphylactoid or anaphylactic reaction to any allergen including drugs and contrast agents
* Subject with renal insufficiency of any intensity, i.e. estimated Glomerular Filtration Rate \<80% of age adjusted normal value calculated based on the Schwartz formula
2 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Savannah, Georgia, United States
Chicago, Illinois, United States
Boston, Massachusetts, United States
Cincinnati, Ohio, United States
Houston, Texas, United States
Edmonton, Alberta, Canada
Dresden, Saxony, Germany
Halle, Saxony-Anhalt, Germany
Jena, Thuringia, Germany
Countries
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Related Links
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Click here to find information about studies related to Bayer Healthcare products conducted in Europe.
Other Identifiers
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2010-023003-96
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
91741
Identifier Type: -
Identifier Source: org_study_id