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

Update Il y a 5 ans
Reference: EUCTR2009-013081-17

Woman and Man

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Extract

Stage 1: To determine the optimal efficacious dose (0.05 mmol/kg or 0.1 mmol/kg BW) of Magnevist Injection Stage 2: To evaluate pharmacokinetics of Magnevist Injection at the optimal efficacious dose from stage 1


Inclusion criteria

  • Contrast-enhanced MRI in children 2 month to < 2 years

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