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

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ClinicalTrials.gov Identifier: NCT02761460
Recruitment Status : Unknown
Verified May 2017 by wang shusen, Sun Yat-sen University.
Recruitment status was:  Recruiting
First Posted : May 4, 2016
Last Update Posted : June 1, 2017
Sponsor:
Information provided by (Responsible Party):
wang shusen, Sun Yat-sen University

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

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: PEG-rhG-CSF Phase 3

Detailed Description:

Neutrophilic granulocytopenias is one of the most common and most serious complications in chemotherapy. Research shows that about 25% ~ 40% in patients receiving standard chemotherapy can appear neutropenia with fever. It can increase the risk of infection and Chemotherapy related death, and lead to the delay of chemotherapy, and maybe Reduce the curative effect of chemotherapy. RhG-CSF has widely used to prevent neutropenia, but its half-time is short, and need daily injections to maintain the effective blood drug concentration. Patients are with poor compliance, related adverse reaction and medical costs increase. At the same time, some patients appear neutropenia thought RhG-CSF is given. Therefore, how to reduce the frequency of RhG-CSF injections and more effectively prevent neutropenia more effectively, on the premise of ensure the safety of patients to achieve better effect of chemotherapy, has always been the focus of the clinical problem.

Pegylated recombinant human granulocyte-colony stimulating factor(PEG-rhG-CSF) is a first class national new drug developed by domestic pharmaceutical companies. According to some phase Ⅱand phase Ⅲ clinical trials, PEG-rhG-CSF has a good effect. The patients need only one injection for PEG-rhG-CSF each Cycle of chemotherapy, and the effect of rising white blood cell is more smoothly, and it can avoid pain of repeated injection of PEG-rhG-CSF


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 338 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Study of Evaluating the Efficacy and Safety of PEG-rhG-CSF in Preventing Chemotherapy-induced Neutropenia
Actual Study Start Date : May 4, 2016
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: PEG-rhG-CSF
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
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




Primary Outcome Measures :
  1. the rate of Ⅲ or Ⅳ class of neutropenia [ Time Frame: 1 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02761460


Contacts
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Contact: Fei Xu, Doctor 13711277870 xufei@sysucc.org.cn

Locations
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China, Guangdong
Shusen Wang Recruiting
Guangzhou, Guangdong, China, 510060
Contact: shusen wang, doctor    13926168469    wangshs@sysucc.org.cn   
Sponsors and Collaborators
wang shusen
Investigators
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Study Chair: Shusen Wang, Doctor Sun Yat-sen University

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Responsible Party: wang shusen, Chief Physician, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT02761460     History of Changes
Other Study ID Numbers: 2015-FXY-083
First Posted: May 4, 2016    Key Record Dates
Last Update Posted: June 1, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Neutropenia
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases