Safety and Efficacy Evaluation of NH002 as a Contrast Agent in Subjects Undergoing Cardiac Echocardiography

NCT06815627 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: NH002-LV-02
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Cardiac Diseases

Keywords

Echo; Echocardiogram; Cardiac ultrasound; suboptimal; contrast agent; enhancing agent; LVO; LVEBD

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (5)

• The number and percentage of subjects with suboptimal echocardiography converted into optimal echocardiography

  Image data obtained pre-injection and within 10 minutes post-injection

• Standard 12-lead ECG QT interval

  From pre-injection to 24 hours post injection

• Blood Pressure (BP)

  From pre-injection to 24 hours post injection

• Heart Rate (HR)

  From pre-injection to 24 hours post injection

• SpO2

  From pre-injection to 24 hours post injection

Study Arms (1)

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.

Drug: NH002 (Perflutren Lipid Microspheres) Injectable Suspension

Interventions

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.

NH002

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• Ability to understand and the willingness to provide written informed consent
• Having or suspected of having cardiac disease
• Undergone a transthoracic echo within 30 days prior to NH002 dose administration, resulting in suboptimal LVEBD, as defined by 2 or more segments of 6 segments of the ventricular border that cannot be visualized reliably in any of the standard apical 4-, 2-, and 3-chamber views during the resting non-contrast ultrasound examination

You may not qualify if:

• 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:
• ongoing or recent acute coronary syndrome within 6 months.
• uncontrolled serious ventricular arrhythmias.
• decompensated or inadequately controlled congestive heart failure (New York Heart Association Class IV).
• atrial fibrillation or current uncontrolled cardiac arrhythmias causing symptoms or hemodynamic compromise.
• uncontrolled hypertension (i.e., resting systolic blood pressure \>200 mmHg or diastolic blood pressure \>110 mmHg or arterial hypotension \[defined as systolic blood pressure ≤ 90 mmHg\]).
• acute aortic dissection.
• 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:
• testing on-site at the institution (serum or urine β-human chorionic gonadotropin) within 24 hours prior to the start of NH002 dose administration, and
• history of using an adequate and medically approved method of contraception to avoid pregnancy for at least 1 month prior to NH002 dose administration and willing to continue using the same method for the duration of the study, or
• surgical history (e.g., tubal ligation or hysterectomy), or

Sponsors & Collaborators

• Trust Bio-sonics, Inc.: lead
• CMIC ASIA-PACIFIC, PTE. LTD., TAIWAN BRANCH: collaborator

Study Sites (6)

Keelung Chang Gung Memorial Hospital & Lovers Lake Branch

Keelung, 204201, Taiwan

RECRUITING

China Medical University Hospital

Taichung, 404327, Taiwan

RECRUITING

MacKay Memorial Hospital

Taipei, 104217, Taiwan

RECRUITING

Cathay General Hospital

Taipei, 106438, Taiwan

RECRUITING

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

RECRUITING

National Taiwan University Hospital Hsin-Chu Branch

Zhubei, 302058, Taiwan

RECRUITING

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

• 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

Central Study Contacts

Shih-Tsung Kang, Ph.D

CONTACT

+886-3-668-4965 Ext.211; charlykang@trust-biosonics.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2025
• First Posted: February 7, 2025
• Study Start: March 18, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: August 26, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (6)