Clinical Trial to Evaluate the Efficacy and Safety of Recombinant Human Neuregulin-1 for Subcutaneous Administration in Patients With Chronic Systolic Heart Failure

This study has suspended participant recruitment.
(The same protocol has been launched in United States.)
Sponsor:
Information provided by (Responsible Party):
Zensun Sci. & Tech. Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01214096
First received: September 28, 2010
Last updated: July 18, 2012
Last verified: July 2012

September 28, 2010
July 18, 2012
July 2010
December 2014   (final data collection date for primary outcome measure)
cardiac function measured by MRI [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01214096 on ClinicalTrials.gov Archive Site
cardiac function [ Time Frame: baseline, 30 days, 90day and180 days ] [ Designated as safety issue: No ]
6-minute walk test, cardiac function classification(NYHA),life quality score.
Same as current
Not Provided
Not Provided
 
Clinical Trial to Evaluate the Efficacy and Safety of Recombinant Human Neuregulin-1 for Subcutaneous Administration in Patients With Chronic Systolic Heart Failure
A Multi-center, Randomized, Double-blind , Placebo Parallel Controlled, Standard Therapy Based Phase III Clinical Trial to Evaluate the Efficacy and Safety of Recombinant Human Neuregulin-1 for Subcutaneous Administration in Patients With Chronic Systolic Heart Failure

Evaluate the Efficacy and Safety of Recombinant Human Neuregulin-1 for Subcutaneous Administration in Patients With Chronic Systolic Heart Failure

  1. Subcutaneous Administration of NRG-1 is well tolerated by CHF patients
  2. Subcutaneous Administration of NRG-1 improves the cardiac function of CHF patients
  3. Assessment of relative bioavailability of NRG-1 by Subcutaneous Administration
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Chronic Heart Failure
  • Drug: rhNRG-1
    Subcutaneous Administration:0.6ug/kg/day for 10days
  • Drug: rhNRG-1
    Subcutaneous Administration 1.2ug/kg/day for 10 days
  • Drug: rhNRG-1
    Vein infusion:0.6ug/kg/day for 10 days
  • Drug: placebo
    Subcutaneous Administration:0.6 or 1.2ug/kg/day for 10days
  • Placebo Comparator: placebo
    Intervention: Drug: placebo
  • Experimental: rhNRG-1
    recombinant human neuregulin-1
    Interventions:
    • Drug: rhNRG-1
    • Drug: rhNRG-1
    • Drug: rhNRG-1
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
120
June 2015
December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Age: 18-75 years old, no limitation in gender;
  2. Left ventricular ejection fraction (LVEF) ≤ 40% (ECHO);
  3. Patients with chronic heart failure (NYHA class II or III);
  4. In the past one month, the clinical condition (including history, clinical symptoms and signs) was relatively stable;
  5. Patients on standard treatment of chronic heart failure at the target dose or maximum tolerance dose for over 1 month ,or unchanged dose in last 1 month;
  6. Understand and sign the informed consent form;

Exclusion Criteria:

  1. Atrial fibrillation;
  2. Subject underwent cardiac pacemaker treatment;
  3. Subject underwent metal graft treatment;
  4. Claustrophobia;
  5. Acute myocardial infarction, cardiac ischemia indicated by 6-minute walk test, hypertrophic cardiomyopathy, constrictive pericarditis, significant valve disease or congenital heart disease, severe pulmonary hypertension;
  6. Ischemic heart failure without the revascularization or undergone the revascularization within last 6 months;
  7. Subject underwent cardiac surgery or cerebrovascular events within the previous six months;
  8. Subjects who plan to have cardiac transplantation;
  9. Severe hepatic and renal insufficiency (serum creatinine>2.0 mg /dl, AST or ALT is five times higher than the upper limit of normal range);
  10. Subject needs mechanical ventilation;
  11. Systolic blood pressure < 90mmHg, or > 160mmHg;
  12. Chronic heart failure complicated with acute hemodynamic disturbance or acute decompensation within last 1 month;
  13. Mobitz Type II or III° atrial ventricular block,severe ventricular arrhythmia (polymorphic and frequent premature ventricular beats, frequent non-sustained ventricular tachycardia);
  14. Serum potassium<3.2mmol/L, or>5.5mmol/L;
  15. Female subject is pregnant or plan to become pregnant
  16. Childbearing-aged female subject who is unmarried or dose not bear child;
  17. Subject with life expectancy less than 6 months as assessed by investigators;
  18. Subject participated in any other clinical trial within the previous three months;
  19. Subject with previous history of tumor, or current tumor patient, or subject with pre-cancerous disease manifested by pathological examination (such as ductal carcinoma in situ or cervical epithelial dysplasia)
  20. Examinations (physical examination, X-ray examination, type-B ultrasonic detection or other methods) reveal that the subject has malignant mass, gland hyperplasia or adenoma with endocrine activity, or impact on heart, or endocrine function (such as pheochromocytoma, thyroid enlargement);
  21. The Investigator deemed for whatever reason that the subject is not likely to complete the study or comply with the study procedures (due to administration or any other reason).
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01214096
ZS-01-302
Yes
Zensun Sci. & Tech. Co., Ltd.
Zensun Sci. & Tech. Co., Ltd.
Not Provided
Principal Investigator: Runlin Gao Cardiovascular Institute and Fuwai Hospital
Zensun Sci. & Tech. Co., Ltd.
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP