NCT01439893

Study of Efficacy on Cardiac Remodeling of Recombinant Human Neuregulin-1 in Stable Chronic Systolic Heart Failure Patients

A Phase III, Multi-center,Randomized, Double-blind, Based on Standard Therapy, Placebo-controlled Study of the Efficacy/Safety of Recombinant Human Neuregulin-1β in Patients With Chronic Systolic Heart Failure

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Zensun Sci. & Tech. Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-center, randomized, double-blind , placebo parallel controlled, standard therapy based phase III clinical trial, to evaluate the efficacy of recombinant human neuregulin-1 on cardiac remodeling, as well as safety in patients with chronic heart failure.

Detailed description

RhNRG-1(recombinant human neuregulin-1)directly works on the cardiomyocytes and restored the normal structure and function of it.Both the preclinical trial and phase II clinical trail have confirmed that rhNRG-1 effectively improved the heart function, and is tolerated in the effective dosage groups. The aim of this phase III trial is to further confirm in large population that rhRNG-1 administration can effectively improve the cardiac remodeling and is tolerated in patients with chronic heart failure.

Conditions

• Chronic Systolic Heart Failure

Interventions

Type	Name	Description
DRUG	rhNRG-1	day1\~day10:0.6ug/kg/day,10hours per day for vein infusion
DRUG	Placebo	day1\~day10:0.6ug/kg/day,10hours per day for vein infusion

Timeline

• Start date: 2011-06-01
• Primary completion: 2012-06-01
• Completion: 2012-06-01
• First posted: 2011-09-23
• Last updated: 2017-12-21

Locations

4 sites across 1 country: China