drugset / Trial / NCT05949801

Evaluation of the Effect of Injectable Neucardin on Cardiac Function and Reversal Ventricular Remodeling in Patients With Chronic Systolic Heart Failure

NCT05949801 ↗

Phase 3 Completed 202 enrolled Zensun Sci. & Tech. Co., Ltd.
RandomizedParallel-groupDouble-blindTreatment

Summary

A multicenter, randomized, double-blind, placebo-controlled phase III clinical trial to evaluate the effect of recombinant human Neuregulin-1 for injection on cardiac function and reverse ventricular remodeling in male patients with NT-proBNP ≤ 1700 pg/ml and female patients with NT-proBNP ≤ 4000 pg/ml and New York Heart Association class II-III chronic systolic heart failure, and to confirm its efficacy and safety.

Timeline

Start
2023-04-13
Primary completion
2024-08-30
Completion
2024-10-14

Drugs

EvaluationDrugModalityDoseRoute
Subject HUMAN NEUREGULIN-1 RECOMBINANT (177-237) Protein / enzyme biologic 0.6 ug/kg Intravenous