The Efficacy and Safety of PEG-rhG-CSF in Preventing Chemotherapy-induced Neutropenia

NCT02761460 | Unknown Phase 3 DMC

• 1 other identifier: 2015-FXY-083
• Study Type: interventional
• Target: 338
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of PEG-rhG-CSF in preventing chemotherapy-induced neutropenia

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• the rate of Ⅲ or Ⅳ class of neutropenia

  1 years

Study Arms (1)

PEG-rhG-CSF

EXPERIMENTAL

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,

Drug: PEG-rhG-CSF

Interventions

PEG-rhG-CSF DRUG

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

PEG-rhG-CSF

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of informed consent Histologically proven breast cancer
• Patients need to accept many cycles chemotherapy alone
• appears III/IV neutropenia after last cycle of chemotherapy, and plan in the subsequent cycle using the same chemotherapy program.
• KPS≥70
• Lifetime is expected to more than 3 months
• Before enrollment,ANC≥ANC ≥1.5×109 /L,Platelet Count (PLT) ≥80×109 /L, White Blood Cell （WBC ）≥3.0×109 /L.
• Sign Informed Consent Form （ICF）.

You may not qualify if:

• There is any difficult to control infection, or within 72 h before chemotherapy received antibiotic treatment systematically
• Any abnormal bone marrow hyperplasia and other hematopoietic function was abnormal
• Suffer from other malignant tumor was not cured, or patients with brain metastasis
• Total Bilirubin （TBIL）,Alanine Transminase （ALT）,Aspartate aminotransferase(AST)\>2.5×ULN
• Cr\>1.5×ULN
• Be allergic to this product or other genetically engineered e. coli sources of biological products
• Mental or neurological disorders
• Women with pregnancy or lactation; The childbearing age women refused to accept contraception
• The investigators think that the person doesn't fit into the group

Sponsors & Collaborators

• wang shusen: lead

Study Sites (1)

Shusen Wang

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

pegylated granulocyte colony-stimulating factor

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Shusen Wang, Doctor

  Sun Yat-sen University

  STUDY CHAIR

Central Study Contacts

Fei Xu, Doctor

CONTACT

13711277870; xufei@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: April 28, 2016
• First Posted: May 4, 2016
• Study Start: May 4, 2016
• Primary Completion: April 1, 2018
• Study Completion: December 1, 2018
• Last Updated: June 1, 2017

Record last verified: 2017-05

Locations

CN (1)