Gadopiclenol Pharmacokinetics, Safety and Efficacy in Children < 2 Years of Age
- Conditions
- Central Nervous System DiseasesPediatric DisorderBody Indication
- Interventions
- Registration Number
- NCT05590884
- Lead Sponsor
- Guerbet
- Brief 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).
- Detailed Description
Three age groups are defined:
* Group 1: patients aged 3 to 23 months (inclusive)
* Group 2: patients aged 28 days to less than 3 months;
* Group 3: patients aged from birth to 27 days (term newborns).
At study set-up, the inclusions started with the oldest patients in group 1 and using an age-down staggered approach.
The decision to start the inclusions in group 2 was taken by the Trial Safety Review Board based on safety assessment over one-day period after injection of the first 13 patients in group 1.
According to the protocol version 4 (amendments 2 \& 3), the age-down staggered approach was discontinued to allow the inclusions in Group 3 (patients aged from birth to 27 days), simultaneously to inclusions in group 1 and group 2.
The inclusions in the three age groups will be completed in parallel. A total of 3 blood samples per patient will be taken post-injection for PK analysis.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
- Female or male pediatric patient aged from birth to 23 months of age inclusive (term neonates for all age groups or preterm infants after the neonatal period for groups 1 or 2). The neonatal period for preterm newborns is defined as the day of birth through the expected date of delivery plus 27 days. Term is defined as ≥37 completed weeks of amenorrhea,
- Patient with known or highly suspected abnormalities/ lesion(s), scheduled to undergo contrast-enhanced MRI of any body region including CNS [...]
Main
-
Patient planned for treatment or procedure (e.g. surgery) that would prevent from obtaining the required blood samples or performing other trial procedures between the screening visit and up to one day after gadopiclenol administration,
-
Patient undergoing treatment or procedure (e.g., diuretics, clinically significant blood loss or blood transfusion) preceding or subsequent to gadopiclenol administration that would alter gadopiclenol pharmacokinetic parameters,
-
Patient with acute or chronic renal insufficiency defined as estimated Glomerular Filtration Rate (eGFR) out of age-adjusted normal value calculated based on bedside Schwartz equation, [...]
-
Patient undergoing a change in chemotherapy (product or dosage) within one day prior to or one day after gadopiclenol administration, 10. Patient who received or will receive any other contrast agent for CT and/or MRI within one week prior to or one week after gadopiclenol administration, 11. Patient with contraindication for MRI such as iron metal implants (e.g., aneurysm clips, pacemaker), 12. Patient with history of anaphylactoid or anaphylactic reaction to any allergen including drugs and contrast agents [...]
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Age Group 1: patients aged 3 to 23 months Gadopiclenol One Investigational Medicinal Product (IMP) dose of 0.05 mmol/kg will be injected in all patients. Age Group 3: patients aged from birth to 27 days (term newborns) Gadopiclenol One Investigational Medicinal Product (IMP) dose of 0.05 mmol/kg will be injected in all patients. Age Group 2: patients aged 28 days to less than 3 months Gadopiclenol One Investigational Medicinal Product (IMP) dose of 0.05 mmol/kg will be injected in all patients.
- Primary Outcome Measures
Name Time Method Simulated concentrations at 10 minutes post injection Concentration is simulated at 10 minutes post injection Determined from population PK
Simulated concentrations at 20 minutes post injection Concentration is simulated at 20 minutes post injection Determined from population PK
Simulated concentrations at 30 minutes post injection Concentration is simulated at 30 minutes post injection Determined from population PK
Area Under the Curve A total of 3 blood samples per patient will be taken post-injection for PK analysis, one within each window (10-60 minutes, 2-4 hours and 6-8 hours). Determined from population PK
Elimination half-life A total of 3 blood samples per patient will be taken post-injection for PK analysis, one within each window (10-60 minutes, 2-4 hours and 6-8 hours). Determined from population PK
Total clearance A total of 3 blood samples per patient will be taken post-injection for PK analysis, one within each window (10-60 minutes, 2-4 hours and 6-8 hours). Determined from population PK
Volume of distribution A total of 3 blood samples per patient will be taken post-injection for PK analysis, one within each window (10-60 minutes, 2-4 hours and 6-8 hours). Determined from population PK
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (11)
Országos Idegtudományi Intézet
🇭🇺Budapest, Hungary
Semmelweis Egyetem
🇭🇺Budapest, Hungary
Szpital Uniwersytecki nr 1 im. dr Antoniego Jurasza
🇵🇱Bydgoszcz, Poland
Uniwersytecki Szpital Dzieciecy
🇵🇱Lublin, Poland
Instytut "Pomnik - Centrum Zdrowia Dziecka"
🇵🇱Warszawa, Poland
University of Debrecen Clinical Center Pediatric Department
🇭🇺Debrecen, Hungary
Uniwersyteckie Centrum Kliniczne Warszawskiego
🇵🇱Warszawa, Poland
Instytut Centrum Zdrowia Matki Polki
🇵🇱Lodz, Poland
Kliniczny Szpital Wojewodzki Nr 2 im. Sw. Jadwigi Krolowej
🇵🇱Rzeszów, Poland
Cincinnatti Childrens Hospital
🇺🇸Cincinnati, Ohio, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States