NCT02140736已完成不适用
Role of biOsimilaRs in Therapeutic Management of Anemia Following Chemotherapy in HEmatology and Oncology; A Prospective, Observational, Non-interventional Study
Hospira, now a wholly owned subsidiary of Pfizer0 个研究点目标入组 2,333 人开始时间: 2009年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,333
- 主要终点
- Change and corrected Hemoglobin levels
研究概览
简要总结
The main aim of this study is to observe correction of the hemoglobin level in the patients under chemotherapy, treated with epoetin alfa biosimilar and presenting with a solid tumor or a lymphoma or a myeloma.
详细描述
This is a non-interventional, descriptive, national, multi-site, longitudinal and prospective observational study with adults patients who are suffering from cancer or malignant blood disease and whose chemotherapy treatment has induced symptomatic anemia and being treated with biosimilar of epoetin 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 of more than 18 years of age
- •Patients presenting with anemia following chemotherapy
- •Patients suffer from solid tumours, malignant hemopathies, lymphomas or myelomas and presenting with anemia following 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 trial
- •Patients presenting with a contraindication to epoetin zeta
- •Patients presenting with hypersensitivity to the active principle or any of the excipients
- •Patient with erythroblastopenia or acquired pure red cell aplasia (APRCA)
- •Patient with uncontrollable arterial hypertension
- •Patients who cannot receive adequate prophylaxis by antithrombotic agents
研究组 & 干预措施
Patients with chemo-induced symptomatic anemia
干预措施: Epoetin biosimilar (Drug)
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
- Observe evolution of the biological indicators(6 months)
- Study the profiles of treated patients(6 months)
- Assess the reasons for the prescriber's treatment regimens(6 months)
- Assess the correlations between the prescribing oncologists' treatment regimens and the patient characteristics(6 months)
- Observation of the safety profiles of the Product (Epoetin Alfa)(6 months)
研究者
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