CompletedPhase 3

Phase III Study of DA-3031(PEG-G-CSF) in Chemotherapy-induced Neutropenia

South Korea74 participantsStarted 2012-02

Plain-language summary

This study is to determine whether once-per-cycle DA-3031(PEG-G-CSF) is not inferior to daily G-CSF in chemotherapy-induced neutropenia.

Age range18 Years – 70 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✕. Prior chemotherapy
✕. Prior bone marrow or stem cell transplantation
✕. Other malignancy history within 5 years
✕. Prior exposure to pegfilgrastim or filgrastim or other colony-stimulating factors
✕. Received any other investigational drugs within 30 days of informed consent date
✕. Radiation therapy within 4 weeks of informed consent date
✕. Infective symptom before chemotherapy into this study
✕. Received systemic antibiotics within 72 hours of randomization into this study.

Duration of grade 4 neutropenia in cycle 1

Timeframe: 21 day

NCT IDNCT01674855

SponsorDong-A ST Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-02