Trials / Terminated
TerminatedNCT01439789
Study of Efficacy on NT-proBNP of Recombinant Human Neuregulin-1 in Chronic 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
- 146 (actual)
- Sponsor
- Zensun Sci. & Tech. Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
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
21 sites across 1 country: China
Source: ClinicalTrials.gov record NCT01439789. Inclusion in this directory is not an endorsement.