Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05590884 · ClinicalTrials.gov registry record · Phase 2
Gadopiclenol Pharmacokinetics, Safety and Efficacy in Children < 2 Years of Age
A Phase 2 study, sponsored by Guerbet.
- Completed
- Registry status
- Phase 2
- Development phase
- 36
- Enrollment target
NCT05590884 is a Phase 2 study that has completed, run by Guerbet. The registered enrollment target is 36 participants.
The verdict
NCT05590884, a Phase 2 study, has completed, sponsored by Guerbet.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 36 participants
- Enrollment target
Study Summary
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).
Interventions
- DRUG Gadopiclenol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2022-09-21 |
| Est. Completion | 2024-09-30 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05590884
The ClinicalTrials.gov registry entry for NCT05590884 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Guerbet, which has 15 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Gadopiclenol is the first listed.
NCT05590884 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05590884 about?
NCT05590884 is a clinical study titled "Gadopiclenol Pharmacokinetics, Safety and Efficacy in Children < 2 Years of Age". 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...
What is the current status of trial NCT05590884?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2022-09-21. Estimated completion is 2024-09-30.
What interventions are being tested in trial NCT05590884?
The interventions under investigation include: Gadopiclenol (DRUG).
Who is sponsoring clinical trial NCT05590884?
This trial is sponsored by Guerbet, which has 15 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.