NCT01627990已完成不适用
The Compatibility of Nivestim™ Under Cytotoxic Chemotherapy in the Treatment of Malignant Diseases
Hospira, now a wholly owned subsidiary of Pfizer43 个研究点 分布在 1 个国家目标入组 386 人开始时间: 2011年6月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 386
- 试验地点
- 43
- 主要终点
- Incidence of hospitalisation due to febrile neutropenia and/or infection
研究概览
简要总结
The purpose of this study is to observe the tolerability, safety and efficacy of preventative treatment using Nivestim™ in patients receiving cytotoxic chemotherapy for cancer.
详细描述
This is a non-interventional, descriptive, national, multi-site, longitudinal and prospective observational study with in-patients adults or minors undergoing cytotoxic chemotherapy, being treated prophylactically with Nivestim™ in order to reduce the duration of neutropenia and to reduce the incidence of chemotherapy-induced Febrile neutropenia (FN).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •No age limit
- •Declaration of informed consent signed by patient or legal guardian
- •Patients with a solid tumour or with a malignant haematological tumour
- •Patients for whom cytotoxic chemotherapy is planned, irrespective of cycle
- •Patients who are due to undergo, or who should undergo, (primary or secondary) prophylactic treatment using Nivestim™, either to shorten the duration of a neutropenia or to prevent the occurrence of chemotherapy induced febrile neutropenia (FN).
排除标准
- •Patients with chronic myeloid leukaemia (CML) or with myelodysplastic Syndrome (MDS)
- •Patients who are hypersensitive to the active substance or to one of the excipients of Nivestim™
- •Patients not undergoing chemotherapy
- •Patients being treated curatively with Granulocyte-Colony Stimulating Factor (G-CSF)
结局指标
主要结局
Incidence of hospitalisation due to febrile neutropenia and/or infection
时间窗: 6 months
次要结局
- Detailed description of tolerability and safety(6 months)
- Prescription routine of G-CSF (Granulocyte Colony-Stimulating Factor)(During the study initiation visit)
- Characterisation of patients being treated with Nivestim™(6 months)
- Treatment with Nivestim™ as part of daily routine(6 months)
- Description of the characteristics of the participating physicians(During the study initiation visit)
- Description of the efficacy of treatment with Nivestim™(6 months)
研究者
研究点 (43)
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