NCT01131637

Study of the Survival of Recombinant Human Neuregulin-1β in Chronic Heart Failure (CHF) Patients

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 331 (actual)
• Sponsor: Zensun Sci. & Tech. Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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 recent 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 and reverse the remodeling of left ventricular in heart failure animals and humans. In this study, we will evaluate efficacy of rhNRG-1 in reducing the death rate of heart failure.

Conditions

• Chronic Heart Failure

Interventions

Type	Name	Description
DRUG	rhNRG-1	day1\~day10:0.6ug/kg/day,10hours per day for vein infusion; week3\~week25:0.8ug/kg/day,10minutes per time per week for vein injection
DRUG	placebo	day1\~day10:0.6ug/kg/day,10hours per day for vein infusion; week3\~week25:0.8ug/kg/day,10minutes per time per week for vein injection

Timeline

• Start date: 2010-04-01
• Primary completion: 2012-06-01
• Completion: 2012-08-01
• First posted: 2010-05-27
• Last updated: 2017-12-21

Locations

43 sites across 1 country: China