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

NCT06711523 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2025-11-25

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Kexing Biopharm Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2025-01-09
Primary Completion
2026-06-30
Completion
2026-06-30

Countries

  • China

Study Locations

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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 NCT06711523 on ClinicalTrials.gov