At a glance
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A Multicenter, Open-Label, Dose Ascending Study to Evaluate the Safety of NH002 as a Contrast Agent in Cardiac Echocardiography
In Brief
A Phase 2 clinical trial evaluating NH002 (Perflutren Lipid Microspheres) Injectable Suspension and Echocardiogram for Cardiac Disease. Completed, enrolled 36 participants across 2 sites.
Detailed Summary
NH002 (Perflutren Lipid Microspheres) Injectable Suspension is an ultrasound contrast agent for use in patients with suboptimal echocardiograms to opacify the left ventricular (LV) chamber and to improve the delineation of the LV endocardial border. The primary objective of this study is to evaluate the safety and tolerability of 3 ascending doses of NH002.
Study Details
Timeline
Interventions
NH002 is formulated as a microbubble injectable suspension for intravenous administration. NH002 requires an activation process prior to use.
Each patient will undergo an unenhanced ultrasound examination and a NH002 contrast-enhanced examination on the same day.