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Survival Study of the Recombinant Human Neuregulin-1β in Subjects With Chronic Heart Failure.

NCT03388593 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1600

Last updated 2024-02-01

No results posted yet for this study

Summary

The purpose of this study is to evaluate efficacy of rhNRG-1 in reducing the death rate of heart failure subjects with baseline NT-proBNP level between 600 pg/ml and 1700 pg/mL and NYHA class II to III.

Conditions

Interventions

DRUG

rhNRG-1

10 hours per day i.v drip for the first 10 days (0.6ug/kg/day), followed by weekly 10 minutes i.v bolus (0.8ug/kg/day), from the 3rd week for 23 weeks

DRUG

Placebo

10 hours per day i.v drip for the first 10 days (0ug/kg/day), followed by weekly 10 minutes i.v bolus (0ug/kg/day), from the 3rd week for 23 weeks

Sponsors & Collaborators

  • Zensun Sci. & Tech. Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Runlin Gao, Ph.D,MD · Fuwai Hospital and Cardiovascular Institute, Chinese Academy of Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-23
Primary Completion
2026-02-28
Completion
2026-02-28

Countries

  • China

Study Locations

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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 NCT03388593 on ClinicalTrials.gov