A Dose Ascending Study to Evaluate the Safety of NH002 as a Contrast Agent in Cardiac Echocardiography

NCT ID: NCT04185246

Last Updated: 2025-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-04
• Study Completion Date: 2020-07-01

Brief 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.

Conditions

Cardiac Disease

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Single arm

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

Group Type: EXPERIMENTAL

NH002 (Perflutren Lipid Microspheres) Injectable Suspension

Intervention Type: DRUG

NH002 is formulated as a microbubble injectable suspension for intravenous administration. NH002 requires an activation process prior to use.

Echocardiogram

Intervention Type: DIAGNOSTIC_TEST

Each patient will undergo an unenhanced ultrasound examination and a NH002 contrast-enhanced examination on the same day.

Interventions

NH002 (Perflutren Lipid Microspheres) Injectable Suspension

NH002 is formulated as a microbubble injectable suspension for intravenous administration. NH002 requires an activation process prior to use.

Intervention Type: DRUG

Echocardiogram

Each patient will undergo an unenhanced ultrasound examination and a NH002 contrast-enhanced examination on the same day.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

1. Male or female subjects 20 years of age or older

2. Ability to understand and the willingness to provide written informed consent

3. Suspected of having cardiac disease or undergoing evaluation of cardiac anatomy for congenital heart disease

4. Negative pregnancy test within 24 hours of the procedure if subject is a woman of childbearing potential

Exclusion Criteria

1. Known right-to-left, bidirectional, or transient right-to-left cardiac shunt(s)

2. Chronic obstructive pulmonary disease

3. Ejection fraction at screening or baseline <40%

4. Uncontrolled serious ventricular arrhythmias or at high risk for arrhythmias due to prolongation of the QT interval (QT corrected by Fridericia's formula >450 msec in males and >470 msec in females)

5. Clinically significant abnormality in renal and liver function tests (alanine aminotransferase/aspartate aminotransferase >2 × upper limit of normal [ULN]; serum creatinine > 1.5 × ULN)

6. Known or suspected hypersensitivity to one or more of the ingredients of NH002, perflutren, or other echocardiographic contrast agent

7. Received an investigational compound within 30 days before enrolling in the study

8. Received any contrast agent either intravascularly or orally within 48 hours before NH002 administration

9. Pregnant or lactating female (conception during the study should be avoided)

10. Serious medical or psychiatric illness/condition likely, in the judgment of the investigator, to interfere with compliance to protocol treatment/research

11. Clinically unstable cardiopulmonary conditions considered not suitable for participation in the trial, in the judgment of the investigator

12. Uncontrolled arterial hypertension (defined as systolic blood pressure ≥ 200 mmHg or diastolic blood pressure ≥ 110 mmHg) or arterial hypotension (defined as systolic blood pressure ≤ 90 mmHg)

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

StatPlus,Inc.

UNKNOWN

Sponsor Role: collaborator

Trust Bio-sonics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wen-Chung Yu

Role: PRINCIPAL_INVESTIGATOR

Taipei Veterans General Hospital, Taiwan

Chung-Lieh Hung

Role: PRINCIPAL_INVESTIGATOR

Taipei Mackay Memorial Hospital

Locations

Taipei Mackay Memorial Hospital

Taipei, , Taiwan

Taipei Veterans General Hospital

Taipei, , Taiwan

Countries

Taiwan

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

NH002-LV

Identifier Type: -

Identifier Source: org_study_id