NCT00115167已完成3 期
A Multicenter, Randomised, Double-Blind, Placebo-Controlled Roll Over Study to Protocol 20010103 of Darbepoetin Alfa for the Treatment of Anemia of Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 371
- 主要终点
- Incidence of adverse events
研究概览
简要总结
The purpose of this study is to determine the safety of darbepoetin alfa beyond 16 weeks of treatment in subjects with anemia of cancer who are not receiving chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Subjects completing the planned 16 weeks of treatment on the 20010103 Anemia of Cancer protocol
排除标准
- •Subjects currently receiving or planned to receive cytotoxic chemotherapy or myelosuppressive radiotherapy
- •Subjects who have other diagnoses not related to the cancer which can cause anemia
- •Known history of seizure disorder
- •Cardiac condition: uncontrolled angina, congestive heart failure, known ejection fraction less than 40%, or uncontrolled cardiac arrhythmia
- •Uncontrolled hypertension
- •Clinically significant systemic infection or chronic inflammatory disease present at the time of enrollment
- •Subject of reproductive potential who is not using adequate contraceptive precautions
- •Concerns for subject's compliance with the protocol procedures
研究组 & 干预措施
Darbepoetin alfa
Experimental
干预措施: Darbepoetin alfa (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of adverse events
时间窗: throughout study
次要结局
- Confirmed antibody formation to investigational product(throughout study)
- Deaths on study(on study)
- Laboratory parameters(throughout study)
- Vital signs (blood pressure)(throughout study)
- Change in PRO scores(from baseline to end of treatment)
研究者
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