CTRI/2012/02/002397已完成3 期
A Phase III Randomized Controlled Open Label Comparative Multicentric Trial To Compare The Safety And Efficacy of Indigenous Recombinant Human Granulocyte Colony Stimulating Factor (rhG-CSF) With Neupogen® In Patients on Myelosuppressive Therapy for Non Myeloid Malignancies.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 7
- 主要终点
- Percentage of patients developing febrile neutropenia (defined as body temperature ≥ 38.2°C or developing a temperature of 38°C twice in a 12-hour period and absolute neutrophil count 0.5 x 10e9/L on the same day of the fever or the day after.
研究概览
简要总结
A Phase III Randomized Controlled Open Label Comparative Multicentric Trial To Compare The Safety And Efficacy of Indigenous Recombinant Human Granulocyte Colony Stimulating Factor (rhG-CSF) With Neupogen® In Patients on Myelosuppressive Therapy for Non Myeloid Malignancies. Patients who meet the eligibility criteria at screening visit will be enrolled into the study. xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /
Safety assessments will include physical examinations, vital signs, clinical laboratory evaluations (blood chemistry, urinalysis, and hematology), and adverse event and serious adverse event monitoring.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Adult subject of either sex aged 18 years or more having any Histologically confirmed malignancy (except myeloid malignancies and myelodysplastic syndromes) undergoing a variety of myelosuppressive chemotherapy regimens 2.Patients should have performance status of 0-2 ECOG (European Cooperative Oncology group (Appendix 3) 3.Subjects with ≥ 20% risk of developing chemotherapy induced febrile neutropenia.
- •Subjects receiving chemotherapy regimens with (Appendix 6), National Comprehensive Cancer Network (NCCN) guideline for myeloid growth factor v.1.2008) intermediate to high risk for febrile neutropenia are eligible.
- •4.Ability of patients to understand and the willingness to sign a written informed consent.
排除标准
- •1.Subject with history or clinical evidence of serious benign medical illnesses including hepatic, renal, respiratory, cardiovascular, endocrine, neurologic, or hematologic disease as determined by the clinical judgment of the Investigator with or without specific investigations.
- •2.Patient has any condition which is considered as a contraindication for the use of GCSF or which, in the opinion of the Investigator may put the patient increased risk versus any supposed benefit of treatment with GCSF.
- •3.Subject with body weight 45 kg 4.Patients have any prior history of bone marrow / stem cell transplantation or may require in near future in the Investigator’s opinion 5.Patients having active infection 6.Patients who have clinically significant uncontrolled medical illness except malignancy 7.Patients having renal impairment (serum creatinine ≥ 1.5 times the upper normal limit) and abnormal liver function total bilirubin ≥ 2 times the upper limit of normal, SGOT & SGPT ≥ 5 times the upper limit of normal) 8.Patients who have involvement of bone marrow 9.Patients receiving simultaneous radiotherapy 10.Current therapy with other investigational drugs or lithium.
- •11.History or clinical evidence of congestive heart failure (NYHA class III-IV).
- •(Appendix 4) 12.Prior treatment with antibiotics, interferons, interleukins, or, colony stimulating factors (including G-CSF, GM- CSF, M-CSF and erythropoietin) within last 10 days of enrolment.
- •13.Pregnant women, nursing women and women not practicing effective contraception.
- •14.Subject with known hypersensitivity to E-coli derived proteins or any component of the study medication.
- •15.Patients with clinical symptoms of acute Hepatitis B or C infection.
- •16.Patients unwilling to give informed consent or unable to follow study procedures.
结局指标
主要结局
Percentage of patients developing febrile neutropenia (defined as body temperature ≥ 38.2°C or developing a temperature of 38°C twice in a 12-hour period and absolute neutrophil count 0.5 x 10e9/L on the same day of the fever or the day after.
时间窗: 14 days
次要结局
- Percentage of patients developing adverse events and/ or changes in laboratory values.(Incidence of neutropenia defined as absolute neutrophil count 0.5 x 10e9/L not associated with fever)
研究者
研究点 (7)
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