NCT01626547已完成不适用
Biosimilar Retacrit™ (Epoetin Zeta) in the Treatment of Chemotherapy-Induced Symptomatic Anaemia in Haematology and Oncology; Non-interventional, Observational, Prospective Study
Hospira, now a wholly owned subsidiary of Pfizer0 个研究点目标入组 291 人开始时间: 2010年12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
- 291
- 主要终点
- Change and corrected Hemoglobin levels
研究概览
简要总结
The purpose of this study is to observe correction of haemoglobin (Hb) levels in patients receiving chemotherapy as a consequence of a solid tumour, a malignant lymphoma or a multiple myeloma and who are treated with Retacrit™.
详细描述
This is a non-interventional, descriptive, national, multi-site, longitudinal and prospective observational study in adult patients who are suffering from cancer or malignant blood disease and whose chemotherapy treatment has induced symptomatic anaemia and being treated with Retacrit® to correct haemoglobin levels.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients age ≥18 years .
- •Patients present with chemotherapy-induced symptomatic anaemia.
- •Patients suffer from solid tumours, malignant lymphomas or multiple myeloma and have developed symptomatic anaemia due to their chemotherapy.
- •The patients may be included regardless of their chemotherapy cycle (from the first cycle until the last cycle)
- •Patients eligible for epoetin alfa biosimilar treatment.
排除标准
- •Patients are not receiving chemotherapy.
- •Patients already included in an epoetin zeta study.
- •Patients presenting with the contraindications to epoetin zeta.
- •Patients presenting with the hypersensitivity to the active substance or any of the excipients.
- •The patient presents erythroblastopenia, or 'pure red cell aplasia' (PRCA).
- •Patients with uncontrolled hypertension.
- •Patients who cannot receive adequate prophylaxis by antithrombotic agents.
结局指标
主要结局
Change and corrected Hemoglobin levels
时间窗: 6 months
Participants who have hemoglobin values between 11 and 12 g/dl after 6 months of treatment.
次要结局
- Evaluation of prescriber's therapy plan(6 months)
- Observation of blood value development(6 months)
- Evaluation of the profiles of treated patients(6 months)
- Observation of the tolerability profile of Epoetin Zeta(6 months)
- Evaluation of the correlation between the therapy plans of prescribing oncologists and patient characteristics(6 months)
研究者
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