Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2026-03-12 @ 1:05 AM
Study NCT ID:
NCT01541202
Status:
TERMINATED
Last Update Posted:
2017-12-21
First Post:
2012-02-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of the Survival of Recombinant Human Neuregulin-1β in Chronic Heart Failure (CHF) Patients
Sponsor:
Zensun Sci. & Tech. Co., Ltd.
Organization:
Study Overview
Official Title:
A Phase III, Multi-center,Randomized, Double-blind, Based on Standard Therapy, Placebo-controlled Study of the Survival of Recombinant Human Neuregulin-1β in Patients With Chronic Systolic Heart Failure
Status:
TERMINATED
Status Verified Date:
2012-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor has designed another study to replace the current study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate efficacy of rhNRG-1 in reducing the death rate of heart failure.
Detailed Description:
The mortality of chronic heart failure patients remains high, in spite of current treatment. RhNRG-1(recombinant human neuregulin-1)directly work on the cardiomyocyte and restored the normal structure and function of it. Both the preclinical trial and phase II clinical trail have confirmed that rhNRG-1 effectively enhance the heart function, reverse the remodeling of left ventricular, and reduce all-cause mortality in heart failure animals and humans. In this phase III study, the investigators will further confirm the efficacy of rhNRG-1 in reducing the death rate of heart failure.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: