NCT00038311已完成3 期
Safety and Efficacy of (PN-152,243)/PN-196,444 in the Prevention of Thrombocytopenia Administered to Patients With High-Risk Sarcoma Receiving Intensive Chemotherapy (Adriamycin and Ifosfamide (AI))
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
- 120
- 试验地点
- 7
- 主要终点
- To evaluate the effectiveness of intravenous rhTPO versus placebo in reducing the cumulative proportion of patients who experience 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 an investigational drug in the prevention of thrombocytopenia in patients with high-risk sarcoma receiving AI (Adriamycin/Ifosfamide) chemotherapy.
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
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must be newly diagnosed with moderate or high-grade sarcoma and be receiving AI (Adriamycin/Ifosfamide) chemotherapy
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 intravenous rhTPO versus placebo in reducing the cumulative proportion of patients who experience severe chemotherapy induced thrombocytopenia.
次要结局
- Identify the effect of rhTPO on 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 were to have adequate hematological recovery to allow on-time chemotherapy administration in the subsequent cycles.
- Assess the safety of multiple IV doses of rhTPO.
- Determine the occurrence and clinical implications of any anti-TPO antibodies.
- Assess the antitumor activity of AI chemotherapy.
- Evaluate the impact of rhTPO prophylaxis on health economics/cost effectiveness.
- Evaluate the impact of rhTPO prophylaxis on patient quality of life.
- Determine serum concentrations of TPO in the context of rhTPO and chemotherapy administration
研究者
研究点 (7)
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