Efficacy and Safety of Human Neuregulin-1 to Treat Stable Chronic Heart Failure (ZS-01-210)
This study is ongoing, but not recruiting participants.
Sponsor:
Zensun Sci. & Tech. Co., Ltd.
Collaborator:
Zensun USA Inc.
Information provided by (Responsible Party):
Zensun Sci. & Tech. Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01251406
First received: November 17, 2010
Last updated: December 20, 2012
Last verified: December 2012
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Purpose
The mortality of chronic heart failure patients remains high. Recombinant human Neuregulin-1 (rhNRG-1, also called Neucardin) is a 61 amino acid peptide that acts directly on damaged heart muscle cells to restore their structure and function. This study will investigate the safety and efficacy of rhNRG-1 to treat stable chronic heart failure.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Heart Failure |
Drug: Placebo Drug: rhNRG-1 Dose 1 Drug: rhNRG-1 Dose 2 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Randomized, Parallel, Placebo-controlled, Double-blind Phase IIa Study of Efficacy and Safety of Recombinant Human Neuregulin-1 (Neucardin) in Subjects With Stable Chronic Heart Failure |
Resource links provided by NLM:
Further study details as provided by Zensun Sci. & Tech. Co., Ltd.:
Primary Outcome Measures:
- Change from baseline in LVEF [ Time Frame: 30 days ] [ Designated as safety issue: No ]Compared to baseline and placebo
Secondary Outcome Measures:
- Six (6) minute walk test [ Time Frame: Day 30, 90, 180, 365 ] [ Designated as safety issue: No ]Compared to baseline and placebo
- Quality of Life Questionnaire (Kansas City Cardiomyopathy Questionnaire) [ Time Frame: Day 30, 90, 180 and 365 ] [ Designated as safety issue: No ]Compared to baseline and placebo
- NYHA class status [ Time Frame: Day 30, 90, 180 and 365 ] [ Designated as safety issue: No ]Compared to baseline and placebo
- All cause mortality and all cause hospitalization [ Time Frame: Days 30, 90, 180 and 365 ] [ Designated as safety issue: No ]Compared to baseline and placebo
- Change in LVESV and LVEDV [ Time Frame: Day 30 ] [ Designated as safety issue: No ]Compared to baseline and placebo
| Estimated Enrollment: | 120 |
| Study Start Date: | January 2012 |
| Estimated Study Completion Date: | July 2013 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Placebo
Subcutaneous administration for daily for 8 hours a day for 10 days
|
Drug: Placebo
Daily subcutaneous administration for 8 hours a day for 10 days
|
|
Experimental: rhNRG-1 Dose 1
Subcutaneous administration for daily for 8 hours a day for 10 days
|
Drug: rhNRG-1 Dose 1
Daily subcutaneous administration for 8 hours a day for 10 days
Other Name: Neucardin
|
|
Experimental: rhNRG-1 Dose 2
Subcutaneous administration for 8 hours a day for 10 days
|
Drug: rhNRG-1 Dose 2
Daily subcutaneous administration for 8 hours a day for 10 days
Other Name: Neucardin
|
Detailed Description:
This randomized, parallel, placebo-controlled, double-blind, multi-center study will assess the safety and efficacy of rhNRG-1 also known as Neucardin as a treatment for stable chronic heart failure.
A total of 120 subjects, who have chronic heart failure with a NYHA classification of II or III, and are on a stable regimen of ACEI/angiotensin receptor blocker (ARB), beta-blocker, and/or diuretic for at least 3 months prior to receiving study medication and anticipated to remain on the stable regimen through the treatment period can enroll as per specific inclusion and exclusion criteria.
Subjects will be hospitalized for 10 days during the treatment period and will be infused subcutaneously with rhNRG-1 or placebo.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Age > 18 years.
- Male or female subjects.
- Have chronic heart failure defined as NYHA classification of II or III.
- Be on a stable regimen of ACEI/ARB and/or beta-blocker 3 months prior to receiving study medication and are expected to remain on a stable HF medication regime throughout the duration of the trial.
- Left ventricular ejection fraction (LVEF) of < 35% as determined at screening by 2-D echocardiography.
- Is able to understand and provide informed consent.
- If subject has dilated cardiomyopathy, ischemic heart disease or corrected valvular heart disease, and had surgery to repair or replace value, the surgery must have been performed 3 months prior to receiving study medication and the surgical area is functioning normally.
- Proper birth control must be used at least 3 weeks prior to the study (women only), during the infusion period of study drug (men and women), 4-weeks after study drug administration (men and women) and the remaining 11 months in the study follow-up (women). Women must have a negative pregnancy test at screening.
- No greater than mild pericardial effusion < 0.5 cm on echocardiography (roughly corresponds to < 100 mL).
- Have an implantable cardioverter-defibrillator (ICD). The ICD should have been implanted at least 3 months prior to receiving study medication. Patients should undergo interrogation of their ICDs between 1 and 7 days before randomization to drug for the previous thirty (30) days. This interrogation would include surveillance for ventricular arrhythmias as well as assessment of ICD discharge(s) and/or anti-tachycardia pacing.
Exclusion Criteria:
- Has chronic heart failure classified as NYHA Class I or IV.
- Has a history of any malignancy or positive test as specified in the pre-cancer screening.
- Have other conditions which in the opinion of the investigator preclude participation in the study, e.g. serious co-morbidity, known or suspected substance abuse or non-compliance.
- Has a body weight >350lbs.
- Has had any cause hospitalization 30 days prior to screening.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01251406
Locations
| United States, California | |
| University of California, San Diego | |
| La Jolla, California, United States, 92037 | |
| Metabolic Clinic and Research Center | |
| Los Angeles, California, United States, 90033 | |
| USC Cardiovascular Division | |
| Los Angeles, California, United States, 90033 | |
| Orange County Research Center | |
| Tustin, California, United States, 92780 | |
| United States, Colorado | |
| University of Colorado Denver | |
| Denver, Colorado, United States, 80045 | |
| United States, Florida | |
| Clearwater Cardiovascular & Interventional Consultants, MD, PA | |
| Clearwater, Florida, United States, 33756 | |
| University of South Florida | |
| Tampa, Florida, United States, 33606 | |
| United States, Iowa | |
| University of Iowa Hospitals and Clinics | |
| Iowa City, Iowa, United States, 52242 | |
| United States, Louisiana | |
| MedPharmics, LLC. | |
| Kenner, Louisiana, United States, 70065 | |
| Benchmark Research | |
| Metairie, Louisiana, United States, 70006 | |
| United States, Texas | |
| East Texas Cardiology | |
| Houston, Texas, United States, 77002 | |
| The Medical Center of Plano | |
| Plano, Texas, United States, 75075 | |
| United States, Virginia | |
| Sentara Cardiovascular Research Institute | |
| Norfolk, Virginia, United States, 23507 | |
Sponsors and Collaborators
Zensun Sci. & Tech. Co., Ltd.
Zensun USA Inc.
Investigators
| Study Chair: | Barry Greenberg, MD | University of California, San Diego |
| Principal Investigator: | Uri Elkayam, MD | LAC/USC Medical Center |
More Information
Publications:
| Responsible Party: | Zensun Sci. & Tech. Co., Ltd. |
| ClinicalTrials.gov Identifier: | NCT01251406 History of Changes |
| Other Study ID Numbers: | ZS-01-210 |
| Study First Received: | November 17, 2010 |
| Last Updated: | December 20, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Zensun Sci. & Tech. Co., Ltd.:
|
Stable Chronic Heart Failure Systolic |
Additional relevant MeSH terms:
|
Heart Failure Heart Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 19, 2013