CTRI/2009/091/000574已完成3 期
Study to evaluate the efficacy and tolerability of Filgrastim in chemotherapy induced neutropenia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Patients able to understand and voluntarily provide written informed consent before screening, following an explanation of the nature and purpose of this study
- •Patients able to adhere to the study visit schedule and other protocol requirements
- •Patients aged 18 years and above
- •Male patients or non-pregnant, non-lactating females
- •Nonmyeloid cancer patients receiving chemotherapy regimens
- •Patients with serum creatinine < 4.5 mg/dL, serum aspartate aminotransferase [AST] < 120 IU/L and alanine aminotransferase [ALT] < 120 IU/L (all values <3 times ULN)
排除标准
- •Women who are pregnant, lactating or of child bearing potential who are not practicing effective methods of contraception
- •Patients hypersensitive to study drugs, components or similar products.
- •Patients with severe chronic neutropenia
- •Patients with myeloid malignancies and myelodysplasia
- •Patients currently receiving radiation therapy or have completed radiation therapy within 14 days before study entry
- •Patients participated in another therapeutic clinical study (i.e., not an epidemiological study or genomic screening study) during the past 30 days, or are likely to simultaneously participate in another therapeutic clinical study
- •Patients with any active infection requiring systemic antimicrobial therapy
- •Known HIV or hepatitis patients
- •History or clinical evidence of a serious medical illness, including renal, hepatic, respiratory, cardiovascular, endocrine, neurologic, psychiatric, hematologic disease, which in the opinion of the investigator will interfere with study participation or with evaluation of the study results
- •History of, or known current problems with, substance abuse, or any medical, psychological, and/or social condition that may interfere with the patient's participation in the study
- •Any condition that could jeopardize the patient's safety and compliance, as judged by the investigator
研究者
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