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Trial to Compare the Efficacy and Safety Of MW05 and PEG-rhG-CSF

NCT04554056 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 586

Last updated 2022-12-02

No results posted yet for this study

Summary

In the study, subjects will scheduled to undergo four 21-days cycles of chemotherapy treatment. Three group were treated with MW05 300 μg/kg or MW05 500 μg/kg or PEG-rhG-CSF 100 μg/kg on the 3th day of each cycle randomized 1:1:1 .

The dose of the experimental drug MW05 in phase III were determined by independent data monitoring committee (IDMC) according to the efficacy and safety of phase II. Subjects were randomly divided into two groups 1:1 to received either MW05 or PEG-rhG-CSF(100 μg/kg) on the 3th day of each chemotherapy cycle.

Conditions

  • Breast Cancer Female

Interventions

DRUG

MW05

Recombinant (yeast secreted) human serum albumin-human granulocyte colony stimulating factor (I) fusion protein injection

DRUG

PEG-rhG-CSF

PEGylated Recombinant Human Granulocyte Colony-Stimulating Factor

Sponsors & Collaborators

  • Mabwell (Shanghai) Bioscience Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-09-21
Primary Completion
2022-08-20
Completion
2022-11-05

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 NCT04554056 on ClinicalTrials.gov