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Pharmacokinetics, Safety and Efficacy of P03277 in Pediatric Patients Undergoing Central Nervous System Contrast-enhanced MRI

Pediatric Patients Clinical Trial

Official title:
Pharmacokinetics, Safety and Efficacy of a New Gadolinium-based Contrast Agent, P03277, in Pediatric Patients From 2 to 17 Years of Age Undergoing Central Nervous System Contrast-enhanced MRI

Clinical Trial Summary

This is a pharmacokinetics (PK), open-label, uncontrolled, multicenter phase II trial with age-staggered approach. The primary objective is to evaluate the PK profile of gadopiclenol in plasma following single IV injection of 0.05 mmol/kg body weight (BW) in pediatric population aged from 2 to 17 years undergoing CNS contrast-enhanced MRI (CNS cohort).

Clinical Trial Description

A population PK approach and an age-down staggered approach will be used. Patients will be recruited into 3 predefined age groups: 12-17, 7-11 and 2-6 years. The inclusions will start with the older group (Adolescents, 12-17 years), followed by Preadolescents (7-11 years) and finally Young Children (2-6 years of age). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03749252
Study type Interventional
Source Guerbet
Contact
Status Completed
Phase Phase 2
Start date November 6, 2018
Completion date August 10, 2020
View Details
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