Study to Determine Safety and Dosage of OPTISON in Pediatric Participants (NCT03740997) | Clinical Trial Compass
CompletedPhase 4
Study to Determine Safety and Dosage of OPTISON in Pediatric Participants
United States39 participantsStarted 2020-12-01
Plain-language summary
Study to determine the safety and appropriate dosage of OPTISON in pediatric participants since OPTISON has been tested in adult participants only during the clinical development
Who can participate
Age range9 Years – 17 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* The participant was between ≥9 and \<18 years of age and weighs ≥20 kg.
* The participant was clinically indicated to undergo a transthoracic echocardiogram.
* The participant had a suboptimal non-contrast echocardiogram defined as ≥2 contiguous segments in any given view that cannot be visualized.
* The participant was able to comply with study procedures.
* A parent or legal guardian of the participant had signed and dated an informed consent form.
* Post-menarchal female participants must have had a negative urine pregnancy test at screening and at pre-dose on the day of OPTISON administration.
* Post-menarchal female participants must have been practicing abstinence, or be using an effective form of birth control (e.g., intrauterine device, oral contraceptives, contraceptive implants or injections, diaphragm with spermicide, cervical cap, or consort use of condom) for at least 30 days before being enrolled in the study
Exclusion Criteria:
* The participant was previously enrolled in this study.
* The participant received an investigational medicinal product within 30 days before or is scheduled to receive one from time of entry into this study until completion of the follow-up period proposed for this study.
* The participant had a known or suspected hypersensitivity to any of the components of OPTISON, blood, blood products, or albumin.
* The participant had pulmonary hypertension or unstable cardiopulmonary conditions.
* The participant had seve…
What they're measuring
1
Mean Total Visualization Score of Qualitative Endocardial Border Delineation (EBD) of the 12 Segments of the Left Ventricle (LV) Wall in Standard Apical 4-chamber (A4C) and Apical 2-chamber (A2C)
Timeframe: Images were captured during the study echocardiogram (0 to 30 minutes) on Day 1 and blinded image evaluations (BIE) were carried out at the study core laboratory following image transfer