A Phase 3 interventional study of rhNRG-1 and Placebo in Chronic Heart Failure, sponsored by Zensun Sci. & Tech. Co., Ltd.. Terminated at 21 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-12-21.
Sponsored by Zensun Sci. & Tech. Co., Ltd. · Phase 3, Interventional, and Treatment
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 serum NT-proBNP, as well as safety in patients with chronic heart failure.
N-terminal proNBP (NT-proBNP) has been proved to be an independent prognostic factor for the long-term prognosis of chronic heart failure patients.RhNRG-1(recombinant human neuregulin-1)directly works on the cardiomyocytes and restored the normal structure and function of it. It has been found that rhNRG-1 effectively decreased the serum level of NT-proBNP,and is tolerated in the effective dosages groups.The aim of this phase III trial is to further confirm in large population that rhRNG-1 administration can effectively decrease the serum level of NT-proBNP and is tolerated in patients with chronic heart failure.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's enrollment of 146 is above the median of 72 across 3,736 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →Zensun Sci. & Tech. Co., Ltd. is the lead sponsor of 10 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Recombinant human neuregulin-1 administration in addition to basic therapy of chronic heart failure
Drug: rhNRG-1
Excipient placebo in addition to basic therapy of chronic heart failure
Drug: Placebo
day1\~day10:0.6ug/kg/day,10hours per day for vein infusion
day1\~day10:0.6ug/kg/day,10hours per day for vein infusion
NT-proBNP
Time frame: 30 days
NT-proBNP
Time frame: 90 days
Six Minutes Walk Distance
Time frame: 30 days and 90 days
NYHA classification
Time frame: 30 days and 90 days
Quality of Life
Time frame: 30 days and 90 days
This study is terminated, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.
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Zensun Sci. & Tech. Co., Ltd.