A Phase 4, Open-Label, Non-randomized, Multicenter Study to Evaluate Safety and Efficacy of Intravenous Administration of OPTISON™ for Contrast- Enhanced Echocardiography in Pediatric Patients

GE-191-008

Study to determine the safety and appropriate dosage of OPTISON in pediatric patients since OPTISON has been tested in adult patients only during the clinical development

2020-12-01

2023-03-30

2023-03-30

Completed

Early phase I

37

Inclusion Criteria: * The subject is between ≥9 and \<18 years of age and weighs ≥20 kg. * The subject is clinically indicated to undergo a transthoracic echocardiogram. * The subject has a suboptimal non-contrast echocardiogram defined as ≥2 contiguous segments in any given view that cannot be visualized. * The subject is able to comply with study procedures. * A parent or legal guardian of the subject has signed and dated an informed consent form. Exclusion Criteria: * The subject was previously enrolled in this study. * The subject has 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 subject has a known or suspected hypersensitivity to any of the components of OPTISON, blood, blood products, or albumin. * The subject has pulmonary hypertension or unstable cardiopulmonary conditions. * The subject has severe liver disease based on medical history. * The subject had a recent (\<6 months) neurological event. * The subject presents any clinically active, serious, life-threatening disease, with a life expectancy of less than 1 month or where study participation may compromise the management of the subject or other reason that in the judgment of the investigator makes the subject unsuitable for participation in the study.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 37, 'type': 'ACTUAL'}}

2023-12-18