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| Name | Class |
|---|---|
| StatPlus,Inc. | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm | Experimental | Subjects will be enrolled with sequential allocation to 1 of 3 cohorts with the following intravenous (IV) doses of NH002: 2.5 µl/kg, 5.0 µl/kg, or 10.0 µl/kg. Each patient will undergo an unenhanced ultrasound examination and a NH002 contrast-enhanced examination 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 |
|---|---|---|
| 12-lead ECGs | Standard 12-lead ECGs will be assessed from pre-injection to 60 minutes post-injection for changes in QT/ corrected QT(QTc) interval (in ms) and ECG morphology; each standard 12-lead ECG assessment will be scored as either normal or abnormal | From pre-injection to 60 minutes post injection |
| Body Temperature | Monitor for any changes in body temperature (in Celsius degree) | From pre-injection to 120 minutes post injection |
| Heart Rate | Monitor for any changes in heart rate (in beats/min) | From pre-injection to 120 minutes post injection |
| Respiratory Rate | Monitor for any changes in respiratory rate (in breaths/min) | From pre-injection to 120 minutes post injection |
| Blood Pressure | Monitor for any changes in blood pressure (in mmHg) | From pre-injection to 120 minutes post injection |
| Thrombin Time (TT) and Activated Partial Thromboplastin Time (aPTT) | Monitor for any changes in TT and aPTT | From pre-injection to 240 minutes post-injection |
| Cardiac Troponin I | Monitor for any changes in Cardiac troponin I | pre-injection and 240 minutes post-injection |
| Measure | Description | Time Frame |
|---|---|---|
| Left Ventricular Opacification (LVO) | The percentage of subjects with moderate or complete left ventricular opacification (LVO), defined by an LVO grade of 2 (moderate) or 3 (complete), as assessed by the blinded central reader(s). The percentage of subjects with complete LVO, defined by an LVO grade of 3 (complete), as assessed by the blinded central reader(s) | Image data obtained pre-injection and within 10 minutes post-injection |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wen-Chung Yu | Taipei Veterans General Hospital, Taiwan | Principal Investigator |
| Chung-Lieh Hung | Taipei Mackay Memorial Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taipei Mackay Memorial Hospital | Taipei | 10449 | Taiwan | |||
| Taipei Veterans General Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1 | Subjects will be enrolled with the following intravenous (IV) doses of NH002: 2.5 µl/kg. Each patient will undergo an unenhanced ultrasound examination and a NH002 contrast-enhanced examination on the same day |
| FG001 | Cohort 2 | Subjects will be enrolled with the following intravenous (IV) doses of NH002: 5.0 µl/kg. Each patient will undergo an unenhanced ultrasound examination and a NH002 contrast-enhanced examination on the same day |
| FG002 | Cohort 3 | Subjects will be enrolled with the following intravenous (IV) doses of NH002: 10.0 µl/kg. Each patient will undergo an unenhanced ultrasound examination and a NH002 contrast-enhanced examination on the same day |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1 | Participants received single intravenous bolus injection dose of NH002 2.5 µl/kg. |
| BG001 | Cohort 2 | Participants received single intravenous bolus injection dose of NH002 5.0 µl/kg. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 12-lead ECGs | Standard 12-lead ECGs will be assessed from pre-injection to 60 minutes post-injection for changes in QT/ corrected QT(QTc) interval (in ms) and ECG morphology; each standard 12-lead ECG assessment will be scored as either normal or abnormal | All abnormal findings of 12-lead ECG interpretations after dosing were assessed as non-clinically significant and not related to NH002. | Posted | Mean | Standard Deviation | millisecond | From pre-injection to 60 minutes post injection |
|
Each subject had to be carefully monitored for the development of any AEs throughout the study from the signing of the informed consent form to 7 days after receipt of the dose of study agent.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1 | Participants received single intravenous bolus injection dose of NH002 2.5 µl/kg. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest discomfort | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Charly Kang | Trust Biosonics, Inc. | +886-3-668-4965 | 211 | charlykang@trust-biosonics.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 13, 2019 | Nov 27, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 7, 2020 | Nov 27, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D004452 | Echocardiography |
| ID | Term |
|---|---|
| D057791 | Cardiac Imaging Techniques |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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The reviewer of echocardiograms in this trial is blinded to the treatment assignments and subject identifiers.
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| Echocardiogram | Diagnostic Test | Each patient will undergo an unenhanced ultrasound examination and a NH002 contrast-enhanced examination on the same day. |
|
| Oxygen Saturation by Pulse Oximetry (SpO2) |
Monitor for any changes in SpO2 |
| From pre-injection to 120 minutes post-injection |
| Rate of Any Potential Adverse Allergic Reaction | Monitor for any potential adverse allergic reaction | From pre-injection to 240 minutes post-injection |
| Cardiac Troponin T | Monitor for any changes in Cardiac troponin T | pre-injection and 240 minutes post-injection |
| Left Ventricular Endocardial Border Delineation (LVEBD) | The change from baseline on the left ventricular endocardial border delineation (LVEBD) score, defined using a standard 12-segment model, as assessed by the blinded central reader(s). The left ventricular (LV) endocardium of the 4- or 2- chamber apical views are divided into 6 segments, with 2 basal, mid- and apical segments in each view. 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 (0-24) is obtained by adding the scores from the 6 individual segments in each of the 2 views. The changes from baseline on LVEBD score of subjects with suboptimal LVEBD at baseline, as defined by 2 or more contiguous segments of 6 segments that cannot be visualized reliably in either the apical 4 and/or the 2-chamber view, as assessed by the blinded central reader(s) | Image data obtained pre-injection and within 10 minutes post-injection |
| Duration of Clinically Useful Contrast | A duration of clinically useful contrast calculated by measuring the time between the disappearance of shadowing effect (useful effect starts) and the time when moderate or full LV enhancement and contrast enhancement are no longer adequate (useful effect ends), as assessed by the blinded central reader(s) | Image data obtained pre-injection and within 10 minutes post-injection |
| Taipei |
| 11217 |
| Taiwan |
| BG002 | Cohort 3 | Participants received single intravenous bolus injection dose of NH002 10.0 µl/kg. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Height | Mean | Standard Deviation | centimeter |
|
| Weight | Mean | Standard Deviation | kilogram |
|
| OG002 | Cohort 3 | Participants received single intravenous bolus injection dose of NH002 10.0 µl/kg. |
|
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| Primary | Body Temperature | Monitor for any changes in body temperature (in Celsius degree) | Posted | Mean | Standard Deviation | Celsius degree | From pre-injection to 120 minutes post injection |
|
|
|
| Primary | Heart Rate | Monitor for any changes in heart rate (in beats/min) | Posted | Mean | Standard Deviation | beats/minute | From pre-injection to 120 minutes post injection |
|
|
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| Primary | Respiratory Rate | Monitor for any changes in respiratory rate (in breaths/min) | Posted | Mean | Standard Deviation | breaths/minute | From pre-injection to 120 minutes post injection |
|
|
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| Primary | Blood Pressure | Monitor for any changes in blood pressure (in mmHg) | Posted | Mean | Standard Deviation | mmHg | From pre-injection to 120 minutes post injection |
|
|
|
| Primary | Thrombin Time (TT) and Activated Partial Thromboplastin Time (aPTT) | Monitor for any changes in TT and aPTT | The total number of subjects in cohort 2 who underwent TT testing was 11. | Posted | Mean | Standard Deviation | seconds | From pre-injection to 240 minutes post-injection |
|
|
|
| Primary | Cardiac Troponin I | Monitor for any changes in Cardiac troponin I | Troponin I was utilized at site 102. The sample sizes were 5, 7, and 7 for cohorts 1, 2, and 3, respectively. | Posted | Mean | Standard Deviation | ng/mL | pre-injection and 240 minutes post-injection |
|
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|
| Primary | Oxygen Saturation by Pulse Oximetry (SpO2) | Monitor for any changes in SpO2 | Posted | Mean | Standard Deviation | percentage | From pre-injection to 120 minutes post-injection |
|
|
|
| Primary | Rate of Any Potential Adverse Allergic Reaction | Monitor for any potential adverse allergic reaction | One subject allergic to the tap (not injection site) at 120 minutes after dosing. It was determined that there was no relationship between the data and the IP. | Posted | Count of Participants | Participants | From pre-injection to 240 minutes post-injection |
|
|
|
| Secondary | Left Ventricular Opacification (LVO) | The percentage of subjects with moderate or complete left ventricular opacification (LVO), defined by an LVO grade of 2 (moderate) or 3 (complete), as assessed by the blinded central reader(s). The percentage of subjects with complete LVO, defined by an LVO grade of 3 (complete), as assessed by the blinded central reader(s) | Posted | Count of Participants | Participants | Image data obtained pre-injection and within 10 minutes post-injection |
|
|
|
| Secondary | Left Ventricular Endocardial Border Delineation (LVEBD) | The change from baseline on the left ventricular endocardial border delineation (LVEBD) score, defined using a standard 12-segment model, as assessed by the blinded central reader(s). The left ventricular (LV) endocardium of the 4- or 2- chamber apical views are divided into 6 segments, with 2 basal, mid- and apical segments in each view. 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 (0-24) is obtained by adding the scores from the 6 individual segments in each of the 2 views. The changes from baseline on LVEBD score of subjects with suboptimal LVEBD at baseline, as defined by 2 or more contiguous segments of 6 segments that cannot be visualized reliably in either the apical 4 and/or the 2-chamber view, as assessed by the blinded central reader(s) | There were 9, 10, and 9 subjects with suboptimal baseline values in cohorts 1, 2, and 3, respectively. | Posted | Mean | Standard Deviation | score on a scale | Image data obtained pre-injection and within 10 minutes post-injection |
|
|
|
| Secondary | Duration of Clinically Useful Contrast | A duration of clinically useful contrast calculated by measuring the time between the disappearance of shadowing effect (useful effect starts) and the time when moderate or full LV enhancement and contrast enhancement are no longer adequate (useful effect ends), as assessed by the blinded central reader(s) | Posted | Mean | Standard Deviation | minutes | Image data obtained pre-injection and within 10 minutes post-injection |
|
|
|
| Primary | Cardiac Troponin T | Monitor for any changes in Cardiac troponin T | Troponin T was utilized at site 101. The sample sizes were 7, 5, and 5 for cohorts 1, 2, and 3, respectively. | Posted | Mean | Standard Deviation | ng/L | pre-injection and 240 minutes post-injection |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Cohort 2 | Participants received single intravenous bolus injection dose of NH002 5.0 µl/kg. | 0 | 12 | 0 | 12 | 2 | 12 |
| EG002 | Cohort 3 | Participants received single intravenous bolus injection dose of NH002 10.0 µl/kg. | 0 | 12 | 0 | 12 | 7 | 12 |
| Chest pain | General disorders | Systematic Assessment |
|
| Chills | General disorders | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| Head discomfort | Nervous system disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Flushing | Vascular disorders | Systematic Assessment |
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| Hot flush | Vascular disorders | Systematic Assessment |
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| Palpitations | Cardiac disorders | Systematic Assessment |
|
| Ocular hyperaemia | Eye disorders | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
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| D014463 | Ultrasonography |
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
|
| Change from baseline at 10 minutes post-dose |
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| Change from baseline at 30 minutes post-dose |
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| Change from baseline at 60 minutes post-dose |
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| Change from baseline at 120 minutes post-dose |
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| Change from baseline at 30 minutes post-dose |
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| Change from baseline at 60 minutes post-dose |
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| Change from baseline at 120 minutes post-dose |
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| Change from baseline at 30 minutes post-dose |
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| Change from baseline at 60 minutes post-dose |
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| Change from baseline at 120 minutes post-dose |
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| Change from baseline (SBP) at 30 minutes post-dose |
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| Change from baseline (SBP) at 60 minutes post-dose |
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| Change from baseline (SBP) at 120 minutes post-dose |
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| Baseline (DBP) |
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| Change from baseline (DBP) at 10 minutes post-dose |
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| Change from baseline (DBP) at 30 minutes post-dose |
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| Change from baseline (DBP) at 60 minutes post-dose |
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| Change from baseline (DBP) at 120 minutes post-dose |
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| Change from baseline (TT) at 120 minutes post-dose |
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| Change from baseline (TT) at 240 minutes post-dose |
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| Baseline (APTT) |
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| Change from baseline (APTT) at 60 minutes post-dose |
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| Change from baseline (APTT) at 120 minutes post-dose |
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| Change from baseline (APTT) at 240 minutes post-dose |
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| Change from baseline (troponin I) at 240 minutes post-dose |
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| Change from baseline at 30 minutes post-dose |
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| Change from baseline at 60 minutes post-dose |
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| Change from baseline at 120 minutes post-dose |
|
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| LVEBD scores_Post-dose (all subjects) |
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| Change from baseline (all subjects) |
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| LVEBD scores_Baseline (subjects with suboptimal LVEBD at baseline) |
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| LVEBD scores_Post-dose (subjects with suboptimal LVEBD at baseline) |
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| Change from baseline (subjects with suboptimal LVEBD at baseline) |
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| Change from baseline (troponin T) at 240 minutes post-dose |
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