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

NCT01251406 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2025-02-10

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Zensun USA Inc.

    collaborator INDUSTRY

  • Zensun Sci. & Tech. Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Barry Greenberg, MD · University of California, San Diego

  • Uri Elkayam, MD · LAC+USC Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2012-12-31
Completion
2014-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01251406 on ClinicalTrials.gov