NCT06711523

Study Evaluating PEG-G-CSF Injectionin Preventing Neutropenia After Chemotherapy

A Phase III Clinical Study of the Efficacy and Safety of Polyethylene Glycolized Human Granulocyte Stimulating Factor Injection (PEG-G-CSF) in Preventing Neutropenia After Chemotherapy

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: Kexing Biopharm Co., Ltd. · Industry
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy, safety, and immunogenicity of PEG-G-CSF Injection (Kexing Biopharmaceutical Co., Ltd.) for the prevention of neutropenia after chemotherapy, using the PEG-G-CSF Injection ( Neulasta®, Amgen Europe B.V.) as a positive control.

Conditions

• Neutropenia, Chemotherapy-Induced Febrile
• Breast Neoplasm Female

Interventions

Type	Name	Description
DRUG	PEG-G-CSF injection (Kexing Biopharmaceutical Co., Ltd.)	This trial was conducted using the IWRS system where subjects were randomly assigned to the test group (PEG-G-CSF injection (Kexing Biopharmaceutical Co., Ltd.)) and control group (Neulasta®，Amgen Europe B.V.) in a 1:1 ratio.
DRUG	PEG-G-CSF injection (Neulasta®，Amgen Europe B.V.)	This trial was conducted using the IWRS system where subjects were randomly assigned to the test group (PEG-G-CSF injection (Kexing Biopharmaceutical Co., Ltd.)) and control group (Neulasta®，Amgen Europe B.V.) in a 1:1 ratio.

Timeline

• Start date: 2025-01-09
• Primary completion: 2026-06-30
• Completion: 2026-06-30
• First posted: 2024-12-02
• Last updated: 2025-11-25

Locations

1 site across 1 country: China