NCT01251406

Efficacy and Safety of Human Neuregulin-1 to Treat Stable Chronic Heart Failure

A Randomized, Parallel, Placebo-controlled, Double-blind Phase IIa Study of Efficacy and Safety of Recombinant Human Neuregulin-1 (Neucardin) in Subjects With Stable Chronic Heart Failure

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: Zensun Sci. & Tech. Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The mortality of chronic heart failure patients remains high. Recombinant human Neuregulin-1 (rhNRG-1, also called Neucardin) is a 61 amino acid peptide that acts directly on damaged heart muscle cells to restore their structure and function. This study will investigate the safety and efficacy of rhNRG-1 to treat stable chronic heart failure.

Detailed description

This randomized, parallel, placebo-controlled, double-blind, multi-center study will assess the safety and efficacy of rhNRG-1 also known as Neucardin as a treatment for stable chronic heart failure. A total of 120 subjects, who have chronic heart failure with a NYHA classification of II or III, and are on a stable regimen of ACEI/angiotensin receptor blocker (ARB), beta-blocker, and/or diuretic for at least 3 months prior to receiving study medication and anticipated to remain on the stable regimen through the treatment period can enroll as per specific inclusion and exclusion criteria. Subjects will be hospitalized for 10 days during the treatment period and will be infused subcutaneously with rhNRG-1 or placebo.

Conditions

• Chronic Heart Failure

Interventions

Type	Name	Description
DRUG	Placebo	Daily subcutaneous administration for 8 hours a day for 10 days
DRUG	rhNRG-1 Dose 1	Daily subcutaneous administration for 8 hours a day for 10 days
DRUG	rhNRG-1 Dose 2	Daily subcutaneous administration for 8 hours a day for 10 days

Timeline

• Start date: 2012-01-01
• Primary completion: 2012-12-01
• Completion: 2014-03-01
• First posted: 2010-12-01
• Last updated: 2025-02-10

Locations

13 sites across 1 country: United States

Regulatory

• FDA-regulated drug study