POST-AUTHORISATION SAFETY COHORT OBSERVATION OF RETACRIT (EPOETIN ZETA) ADMINISTERED SUBCUTANEOUSLY FOR THE TREATMENT OF RENAL ANAEMIA (PASCO II)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 4,501
- 试验地点
- 165
- 主要终点
- Incidence Rate of Adverse Events of Special Interest
研究概览
简要总结
The purpose of this study is to estimate the incidence of Pure Red Cell Aplasia (PRCA), neutralising antibodies, lack of efficacy, and thromboembolic events under treatment with Retacrit™ (epoetin zeta) administered subcutaneously in patients with renal anaemia. The other key objective of this study is to obtain information on adverse drug reactions (ADR) associated with Retacrit™ (epoetin zeta), use of epoetin zeta during pregnancy and lactation and data on long term use.
详细描述
This is a non-interventional, multi-centre, longitudinal observation with a defined population using a prospective cohort design to estimate the incidence of Pure Red Cell Aplasia (PRCA), neutralising antibodies, lack of efficacy, and thromboembolic events under treatment with Retacrit™ (epoetin zeta) administered subcutaneously in patients with renal anaemia.
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
- 0 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients currently under treatment with Retacrit™ (epoetin zeta) administered subcutaneously for renal anaemia.
- •Informed consent given in writing after being provided with detailed information about the characteristics of this observation by the physician.
- •Patients expected to be available for 3 years of observation
排除标准
- •Any contraindications as per the current Summary of Product Characteristics (SPC) of Retacrit™
结局指标
主要结局
Incidence Rate of Adverse Events of Special Interest
时间窗: 156 weeks
Ongoing routine doctor visits for 156 weeks
次要结局
- Data on long term use(156 weeks)
- Adverse drug reactions(156 weeks)
- Information on treatment with Retacrit during pregnancy and lactation(156 weeks)