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: Completed Phase 2 study, sponsored by Guerbet.
NCT05590884 is a Phase 2 study that has completed, run by Guerbet. The registered enrollment target is 36 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
Exposure parameter by age group predicted from the final model in participants with normal renal function receiving gadopiclenol at a dose of 0.05 mmol/kg
Interventions
- DRUG Gadopiclenol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2022-09-21 |
| Est. Completion | 2024-09-30 |
| Phase | Phase 2 |
What the finished NCT05590884 record still lists
NCT05590884 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 1 intervention - of which Gadopiclenol is the first listed.
NCT05590884 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT05590884's enrollment target sits among peer trials
36 1496th of 2000 higher than 477 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00929006 · 36 participants · Early Phase 1
Acute Progesterone Suppression of Wake vs. Sleep Luteinizing Hormone Pulse Frequency in Pubertal Girls With and Without Hyperandrogenism
- NCT01891318 · 36 participants · Phase 1
Neoadjuvant Radiosurgery for Resectable Brain Metastases: Phase I/II Study
- NCT02291848 · 36 participants · Phase 1
Tumor-Associated Antigen-Specific Cytotoxic T-Lymphocytes for Multiple Myeloma
- NCT02366819 · 36 participants · Phase 4
Genetic Analysis-Guided Irinotecan Hydrochloride Dosing of mFOLFIRINOX in Treating Patients With Locally Advanced Gastroesophageal or Stomach Cancer
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI