Open-label, multi-center, two-stage, age stratified, pharmacokinetic, safety, and efficacy study in children 2 month to < 2 years of age undergoing Magnevist Injection enhanced MRI - Magnevist pediatric pharmacokinetic

Bayer HealthCare Pharmaceuticals, Inc.0 个研究点目标入组 45 人开始时间: 2009年8月10日最近更新: 2012年7月31日

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•All subjects must meet all of the following criteria in order to participate in this study:
•1. Is at least 2 month but less than 2 years of age
•2. Is scheduled to undergo routine Gd-enhanced MRI
•3. Signed and dated written informed consent of the legal representative(s)
•4. Is able to comply with the study procedures (e.g. will be able for 8 hours after the MRI examination and for follow-up at 24 [+/- 6] hours after the administration of Magnevist Injection)
•5. Is able to provide contact information for at least 30 days post-injection for a follow-up phone call
•Are the trial subjects under 18? yes
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•A subject who meets any of the following criteria shall not participate in this study:
•1. Is considered to be clinically unstable (i.e., the underlying clinical condition is such that clinically relevant changes in clinical condition can reasonably be anticipated during the study period). Examples include subjects in intensive care and polytrauma subjects.
•2. Has undergone chemotherapy = 48 hours prior to or is scheduled for chemotherapy up to 24 hours after administration of Magnevist Injection
•3. Is scheduled for any intervention post-baseline evaluations and up to 24 hours after administration of Magnevist Injection
•4. Has participated in a clinical trial of an investigational drug within 30 days prior to consideration for participation in this trial
•5. Has received any other contrast agent within 30 hours prior to injection of Magnevist Injection or is likely to receive one during the 24-hour follow-up period
•6. Has a contraindication for MRI (e.g. pacemaker, aneurysm clips)
•7. Has a history of anaphylactoid or anaphylactic reaction to any allergen including drugs and contrast agents
•8. Is known to have renal insufficiency (i.e. GFR < 80% of age-adjusted normal value)
•9. Has known and clinically relevant (e.g. more than 2 times upper limit of reference range) deviations of available clinical laboratory parameters from reference ranges
•10. Previous participation in this study

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