Clinical trial · Interventional
The Efficacy and Safety of PEG-rhG-CSF in Preventing Chemotherapy-induced Neutropenia
The Study of Evaluating the Efficacy and Safety of PEG-rhG-CSF in Preventing Chemotherapy-induced Neutropenia
NCT02761460CI-TRIAL-00027942unknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the safety and efficacy of PEG-rhG-CSF in preventing chemotherapy-induced neutropenia
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PEG-rhG-CSF | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PEG-rhG-CSF
- description
- PEG-rhG-CSF 6mg is given for patients Greater than or equal to 45 kg, 3mg is given for those less than 45kg 24-48 hours after chemotherapy,
- interventionNames
- Drug: PEG-rhG-CSF
Primary outcomes (1)
- measure
- the rate of Ⅲ or Ⅳ class of neutropenia
- timeFrame
- 1 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Provision of informed consent Histologically proven breast cancer 2. Patients need to accept many cycles chemotherapy alone 3. appears III/IV neutropenia after last cycle of chemotherapy, and plan in the subsequent cycle using the same chemotherapy program. 4. KPS≥70 5. Lifetime is expected to more than 3 months 6. Before enrollment,ANC≥ANC ≥1.5×109 /L,Platelet Count (PLT) ≥80×109 /L, White Blood Cell (WBC )≥3.0×109 /L. 7. Sign Informed Consent Form (ICF). Exclusion Criteria: 1. There is any difficult to control infection, or within 72 h before chemotherapy received antibiotic treatment systematically 2. Any abnormal bone marrow hyperplasia and other hematopoietic function was abnormal 3. Suffer from other malignant tumor was not cured, or patients with brain metastasis 4. Total Bilirubin (TBIL),Alanine Transminase (ALT),Aspartate aminotransferase(AST)\>2.5×ULN 5. Cr\>1.5×ULN 6. Be allergic to this product or other genetically engineered e. coli sources of biological products 7. Mental or neurological disorders 8. Women with pregnancy or lactation; The childbearing age women refused to accept contraception 9. The investigators think that the person doesn't fit into the group
References
Publications (0)
Data not yet available
No reference posted for this study.