Efficacy and Safety of Human Neuregulin-1 to Treat Stable Chronic Heart Failure (ZS-01-210)

This study has been completed.
Sponsor:
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: August 4, 2014
Last verified: August 2014
  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
Study Completion Date: March 2014
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: August 4, 2014
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 October 19, 2014