NCT00037791已完成3 期
Safety and Efficacy of (PN-152,243)/PN-196,444 in the Prevention of Thrombocytopenia in Patients Receiving Myelosuppressive Treatment Regimens Requiring Platelet Transfusion Support.
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 180
- 试验地点
- 10
- 主要终点
- To evaluate the effectiveness of two schedules of intravenous rhTPO versus placebo as secondary prophylaxis in reducing the proportion of patients requiring platelet transfusion for severe chemotherapy-induced thrombocytopenia.
研究概览
简要总结
Intensive chemotherapy is associated with significant thrombocytopenia, often requiring platelet transfusion to maintain platelet counts. This investigational drug has demonstrated the ability to increase platelet counts. This study will test the safety and efficacy of this investigational drug in the prevention of thrombocytopenia in patients with solid tumors, lymphomas or multiple myeloma who are receiving myelosuppressive treatment regimens requiring platelet transfusion support.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double
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 must have solid tumors, lymphomas or multiple myeloma who are receiving myelosuppressive treatment regimens requiring platelet transfusion support
排除标准
- •Patients must not have active bleeding (exclusions do apply) or history of platelet disorder
结局指标
主要结局
To evaluate the effectiveness of two schedules of intravenous rhTPO versus placebo as secondary prophylaxis in reducing the proportion of patients requiring platelet transfusion for severe chemotherapy-induced thrombocytopenia.
次要结局
- Identify the effect of rhTPO on the number of episodes of severe chemotherapy-induced thrombocytopenia(platelet count <15,000/mm3) and the number of platelet transfusions
- Evaluate the severity and duration of thrombocytopenia and neutropenia associated with rhTPO Prophylaxis
- Quantify the effect of rhTPO on the occurrence of any bleeding events associated with thrombocytopenia
- Assess the likelihood that patients will have adequate hematologic recovery to allow on-time chemotherapy administration in the subsequent cycle
- Assess the safety of multiple intravenous doses of rhTPO
- Determine the occurrence and clinical implications of any anti-rhTPO antibodies
- Evaluate the impact of rhTPO prophylaxis on health economics/cost effectiveness
- Evaluate the impact of rhTPO administration on patient quality of life
研究者
研究点 (10)
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