Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| CMIC ASIA-PACIFIC, PTE. LTD., TAIWAN BRANCH | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
This is a Phase 3, prospective, open-label, multicenter study to assess the efficacy of NH002-enhanced echocardiography in subjects with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the left ventricular endocardial border delineation compared with unenhanced echocardiography. The study also aims to investigate the safety and tolerability of NH002.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NH002 | Experimental | Subjects will undergo an unenhanced ultrasound examination and a NH002 contrast-enhanced examination (following intravenous (IV) doses of NH002: 2.5 µl/kg) on the same day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NH002 (Perflutren Lipid Microspheres) Injectable Suspension | Drug | NH002 is formulated as a microbubble injectable suspension for intravenous administration. NH002 requires an activation process prior to use. |
| Measure | Description | Time Frame |
|---|---|---|
| Left Ventricular Endocardial Border Delineation (LVEBD) | The first primary efficacy endpoint will be the change from baseline in total LVEBD scores (UEUS vs CEUS) defined using a 16-segment model derived from the standard 17-segment model, as assessed through blinded central reading. The LV endocardium of the standard apical 4-, 2-, and 3-chamber views is divided into 6 segments, with 2 basal, mid-, and apical segments in each view, of which 2 segments are shared in the standard apical 4- and 3-chamber views (i.e., a total of 16 segments in the 3 views). The 17th segment at the apex will not be scored since it does not connect to any part of the LV endocardial border. For each segment, LVEBD is graded as follows: 0 = inadequate border (border not visible); 1 = sufficient (border barely visible); 2 = good (border clearly visible). A total delineation score (0 to 32) is obtained by adding the scores from a total of the 16 segments in the 3 views. | Image data obtained pre-injection and within 10 minutes post-injection |
| Left Ventricular Opacification (LVO) | The co-primary endpoint will be the proportion of subjects with adequate LVO defined by an LVO grade of +2 (moderate) or +3 (complete), as assessed through blinded central reading. | Image data obtained pre-injection and within 10 minutes post-injection |
| Measure | Description | Time Frame |
|---|---|---|
| The number and percentage of subjects with suboptimal echocardiography converted into optimal echocardiography | Objective evaluation of the number and percentage of subjects with suboptimal echocardiography (based on the definition of inadequate LVEBD; i.e., at least two segments [combined chamber view] with an LVEBD score of 0) converted into optimal echocardiography following administration of study drug will be summarized for each reader. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Subjects will be excluded from the study if one or more of the following exclusion criteria are applicable:
Any evidence of other severe or unstable cardiopulmonary and/or systemic hemodynamic conditions deemed unsuitable for the study by the investigator(s) prior to NH002 dose administration, including, but not limited to:
Known or suspected hypersensitivity to one or more of the ingredients of NH002, perflutren, Definity®, or other echocardiographic contrast agents
Known or suspected hypersensitivity to polyethylene glycol, prior reactions to common polyethylene glycol-containing products such as colonoscopy bowel preparations, and certain laxatives (e.g., Miralax)
Received an investigational compound within 30 days before enrolling in the study
Received any contrast agent either intravascularly or orally within 48 hours prior to NH002 dose administration
Pregnant or lactating female. Exclude the possibility of pregnancy:
Serious medical or psychiatric illness/condition likely, in the judgment of the investigator, to interfere with compliance to protocol treatment/research
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Wen-Chung Yu | Taipei Veterans General Hospital, Taiwan | Principal Investigator |
| Chung-Lieh Hung | Mackay Memorial Hospital | Principal Investigator |
| Chih-Hui Chin | Cathay General Hospital | Principal Investigator |
| Hsin-Yueh Liang | China Medical University Hospital | Principal Investigator |
| Ning-I Yang | Chang Gung Memorial Hospital | Principal Investigator |
| Chien-Boon Jong | National Taiwan University Hospital Hsin-Chu Branch | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Keelung Chang Gung Memorial Hospital & Lovers Lake Branch | Keelung | 204201 | Taiwan | |||
| China Medical University Hospital |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Image data obtained pre-injection and within 10 minutes post-injection |
| Standard 12-lead ECG QT interval | Standard 12-lead ECG QT interval assessed prior to injection and at 10 and 30 minutes after the end of injection; and at 24 hours after the end of injection | From pre-injection to 24 hours post injection |
| Blood Pressure (BP) | Changes in BP assessed prior to injection and at 5, 10, and 30 minutes the end of after injection; and at 24 hours after the end of injection | From pre-injection to 24 hours post injection |
| Heart Rate (HR) | Changes in HR assessed prior to injection and at 5, 10, and 30 minutes the end of after injection; and at 24 hours after the end of injection | From pre-injection to 24 hours post injection |
| SpO2 | SpO2 assessed by pulse oximetry prior to injection and at 5, 10, and 30 minutes after the end of injection; and at 24 hours after the end of injection | From pre-injection to 24 hours post injection |
| Taichung |
| 404327 |
| Taiwan |
| MacKay Memorial Hospital | Taipei | 104217 | Taiwan |
| Cathay General Hospital | Taipei | 106438 | Taiwan |
| Taipei Veterans General Hospital | Taipei | 11217 | Taiwan |
| National Taiwan University Hospital Hsin-Chu Branch | Zhubei | 302058 | Taiwan |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
Not provided
Not provided