At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 80 enrolled

Drug / intervention

P03277drug

Likely dose

P03277 0.1 mLfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03749252

NCT03749252Phase 2Completed

Compare CT.gov

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

Guerbet·interventional·Posted Nov 21, 2018·Updated Jun 1, 2022

In Brief

A Phase 2 clinical trial evaluating P03277 for Central Nervous System Indication and 2 related conditions. Completed, enrolled 80 participants across 16 sites in 5 countries.

Detailed 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).

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsCentral Nervous System Indication, Pediatric Patients, Body Indication

CountriesBulgaria, Hungary, Poland, Slovakia, Ukraine

Collaborators--

Timeline

Phase 2CompletedFinished

20192020202120222023202420252026

Enrollment StartNov 2018

First PostedNov 2018

Primary CompletionDec 2019

Study CompletionAug 2020

TodayJul 2026

First PostedNov 21, 2018

Enrollment StartNov 6, 2018

Primary CompletionDec 18, 2019

Study CompletionAug 10, 2020

TodayJul 2, 2026

Enrollment to primary: 1.1 yearsPosted 7.6 years ago

Interventions

P03277drug

A dose of 0.05 mmol/kg body weight (0.1 mL/kg body weight) of P03277 will be administered to each patient in a single intravenous injection.