NCT01214096

Clinical Trial to Evaluate the Efficacy and Safety of Recombinant Human Neuregulin-1 for Subcutaneous Administration in Patients With Chronic Systolic Heart Failure

A Multi-center, Randomized, Double-blind , Placebo Parallel Controlled, Standard Therapy Based Phase III Clinical Trial to Evaluate the Efficacy and Safety of Recombinant Human Neuregulin-1 for Subcutaneous Administration in Patients With Chronic Systolic Heart Failure

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Zensun Sci. & Tech. Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Evaluate the Efficacy and Safety of Recombinant Human Neuregulin-1 for Subcutaneous Administration in Patients With Chronic Systolic Heart Failure

Detailed description

1. Subcutaneous Administration of NRG-1 is well tolerated by CHF patients 2. Subcutaneous Administration of NRG-1 improves the cardiac function of CHF patients 3. Assessment of relative bioavailability of NRG-1 by Subcutaneous Administration

Conditions

• Chronic Heart Failure

Interventions

Type	Name	Description
DRUG	rhNRG-1	Subcutaneous Administration:0.6ug/kg/day for 10days
DRUG	rhNRG-1	Subcutaneous Administration 1.2ug/kg/day for 10 days
DRUG	rhNRG-1	Vein infusion:0.6ug/kg/day for 10 days
DRUG	placebo	Subcutaneous Administration:0.6 or 1.2ug/kg/day for 10days

Timeline

• Start date: 2010-07-01
• Primary completion: 2011-01-01
• Completion: 2011-01-01
• First posted: 2010-10-04
• Last updated: 2017-12-21

Locations

4 sites across 1 country: China