Gadopiclenol Pharmacokinetics, Safety and Efficacy in Children < 2 Years of Age

Completed · Phase 2

Conditions studied: Central Nervous System Diseases, Pediatric Disorder, Body Indication

In brief

This Phase II open-label, uncontrolled, multicenter trial is designed to investigate the pharmacokinetic (PK) profile of gadopiclenol in plasma, in pediatric patients aged up to 23 months inclusive (term neonates or preterm infants after the neonatal period), using a population PK approach. Primary objective is to evaluate the PK profile of gadopiclenol in plasma following single intravenous injection of 0.05 mmol/kg body weight (BW) in pediatric population aged up to 23 months (inclusive) scheduled for a contrast-enhanced MRI examination of any body region including central nervous system (CNS).

Key facts

Study ID

NCT05590884

Run by

Guerbet

People needed

36

Starts

2022-09-21

Expected to finish

2024-09-30

Last updated by the study team

2025-10-28

Who can join

Age: any, up to 2. Sex: any. Healthy volunteers: not accepted.

Where it is running

• Cincinnatti Childrens Hospital — Cincinnati, Ohio, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Semmelweis Egyetem — Budapest, Hungary
• Országos Idegtudományi Intézet — Budapest, Hungary
• University of Debrecen Clinical Center Pediatric Department — Debrecen, Hungary
• Szpital Uniwersytecki nr 1 im. dr Antoniego Jurasza — Bydgoszcz, Poland
• Instytut Centrum Zdrowia Matki Polki — Lodz, Poland
• Uniwersytecki Szpital Dzieciecy — Lublin, Poland
• Kliniczny Szpital Wojewodzki Nr 2 im. Sw. Jadwigi Krolowej — Rzeszów, Poland
• Uniwersyteckie Centrum Kliniczne Warszawskiego — Warsaw, Poland
• Instytut "Pomnik - Centrum Zdrowia Dziecka" — Warsaw, Poland

Full record on ClinicalTrials.gov

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