EUCTR2007-000054-31-GB进行中（未招募）1 期
An Open-Label, Phase IV, Multi-Centre Study to Investigate the Long-Term Safety and Efficacy of Subcutaneous Dynepo in Adult Patients with Anaemia Associated with Chronic Kidney Disease. - Dynepo long-term safety study
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Shire
- 入组人数
- 416
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Patients who complete Dynepo study SPD490-301.
- •Patients who continue to require epoetin (EPO) treatment and have had a Hb level of >=10g/dL at Week 20 of study SPD490-301.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Withdrawal, before Week 24, from SPD490-301.
- •Pregnant or lactating women.
- •Uncontrolled hypertension.
- •Thrombocytopenia (platelet count <75,000/mm3).
- •Active bleeding disorder (diathesis) (for example, gastrointestinal bleeding or genitourinary tract bleeding).
- •Treatment with immunosuppressive drugs (other than corticosteroids for a chronic condition) in the 30 days immediately prior to enrolment in this study.
- •Androgen therapy in the 30 days immediately prior to enrolment in this study.
- •Known Human Immunodeficiency Virus (HIV) infection.
- •History of hypersensitivity to Dynepo.
- •Known to have Ab against EPO.
研究者
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