Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Optimark (Gadoversetamide) in Pediatric Patients

Completed · Phase 4

Conditions studied: Pathological Processes

In brief

The objective of this study is to characterize the safety, efficacy and pharmacokinetic profiles of Optimark at the standard clinical dose of 0.1 mmol/kg in the pediatric patient population.

Key facts

Study ID

NCT01092754

Run by

Guerbet

People needed

100

Starts

2002-05-01

Expected to finish

2003-12-01

Last updated by the study team

2017-08-01

Who can join

Age: 2 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 2 thru 18 years of age
• referred for MRI of the liver or CNS
• if female and of child-bearing potential, must have negative pregnancy test within 24 hours of study drug administration
• if applicable, agree to use medically accepted method of contraception throughout the study
• if necessary, patients entering the PK subgroup must be willing to be housed within the investigational facility for a minimum of 24 hours following drug administration
• understand the requirements of the study and provide written consent to participate, agree to abide by the study requirements

You may not qualify if…

• previously entered into this study or a previous study using Optimark
• received investigational drug within 30 days of admission into this study or plan to participate in a clinical study prior to the end of this study's monitoring period. (patients on a research protocol using an approved drug ar acceptable)
• medical condition, serious intercurrent illness, or extenuating circumstance that would significantly decrease study compliance and all prescribed follow up
• known or suspected abnormal renal function for age or requiring dialysis during the study period
• pregnant or breastfeeding
• scheduled to undergo any contrast-enhanced examination within 7 days prior to baseline examination or during the course of this study period
• condition that is a contraindication to MRI (i.e., cardiac pacemaker, epicardial pacemaker leads, cochlear implants, ferromagnetic aneurysm clip, ferromagnetic halo device, or other condition that would preclude patient proximity to a strong external magnetic field)
• experienced a previous hypersensitivity reaction to a gadolinium-based contrast agent
• recent history of hemolytic anemia, sickle cell anemia, or other hemoglobinopathy
• undergone a surgical procedure within one week prior to study admission or are planned to undergo a surgical procedure during study participation (central line placement is acceptable)
• history of significant claustrophobia
• weighs less than 25 lbs (11 kgs)

Where it is running

• Arkansas Childrens Hospital — Little Rock, Arkansas, United States
• Childrens Hospital and Health Center — San Diego, California, United States
• Miami Children's Hospital — Miami, Florida, United States
• Children's Mercy Hospitals and clinics — Kansas City, Kansas, United States
• Louisiana State University Sciences Center- Shreveport — Shreveport, Louisiana, United States
• Childrens Hospital of Michigan — Detroit, Michigan, United States
• Cardinal Glennon Childrens Hospital — St Louis, Missouri, United States
• St. Louis Childrens Hospital — St Louis, Missouri, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• University Hospitals of Cleveland — Cleveland, Ohio, United States
• The Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• Texas Childrens Hospital — Houston, Texas, United States

Full record on ClinicalTrials.gov

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