NCT01317966撤回不适用
A Multicentre Investigation of Recombinant Human Interleukin-11 (rhIL-11) Combination Low-dose Rituximab in Management of Steroid-Resistant/Relapsed Immune Thrombocytopenia (ITP)
Ming Hou1 个研究点 分布在 1 个国家开始时间: 2011年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Evaluation of platelet response (Complete Response)
研究概览
简要总结
The purpose of this study is to determine whether Recombinant Human Interleukin-11 (rhIL-11) Combination Low-dose Rituximab prednisone are effective and safe in the management of Steroid-Resistant/Relapsed Immune Thrombocytopenia (ITP).
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
- 16 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients may be male or female, between the ages of 16 ~ 75 years old.
- •Isolated thrombocytopenia with an otherwise normal peripheral blood smear and no other causes of thrombocytopenia, morphologically normal bone marrow aspirate with normal to increased number of megakaryocytes, and absence of splenomegaly.
- •To show a platelet count ≤ 30 × 109/L, or platelet count ≥ 30 × 109/L with bleeding manifestations at the moment of the first infusion with the study product.
- •ＥＣＯＧ performance status ≤
- •Patients failed to respond to acceptable dose of steroids for 4 weeks, or relapsed. Some patients were also refractory to splenectomy.
- •Patients must be willing and able to give written informed consent.
排除标准
- •Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 3 months before the screening visit.
- •Received second-line ITP-specific treatments (eg, cyclophosphamide, 6-mercaptopurine, vincristine, vinblastine, etc) within 3 months before the screening visit.
- •Received high-dose steroids or IVIG in the 3 weeks prior to the start of the study.
- •Current HIV infection or hepatitis B virus or hepatitis C virus infections.
- •Severe medical condition (lung, hepatic or renal disorder) other than chronic ITP. Unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiac arrhythmia).
- •Female patients who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period.
- •Have a known diagnosis of other autoimmune diseases, established in the medical history and laboratory findings with positive results for the determination of antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct Coombs test.
- •Patients who are deemed unsuitable for the study by the investigator (or coinvestigator).
研究组 & 干预措施
rhIL-11Combinating Low-dose Rituximab
rhIL-11 (interleukin-11, Juheli) 50 mcg/kg subcutaneously daily for 14 days
Rituximab 100mcg weekly for 4 weeks
干预措施: rhIL-11 (Drug)
结局指标
主要结局
Evaluation of platelet response (Complete Response)
时间窗: The time frame is up to 14 days per subject
CR. A complete response (CR) was defined as a sustained (≥ 4 months) platelet count ≥ 100×109/L without recurrence of thrombocytopenia
次要结局
- Evaluation of platelet response (R)(The time frame is up to 14 days per subject)
- DFS(The time frame is up to 90 days per subject.)
- The time of rhIL-11 onset.(The time frame is up to 28 days per subject.)
- The number and frequency of IL-11 associated adverse events.(up to 14 days per subject)
研究者
Ming Hou
Director of Hematology Department
Shandong University
研究点 (1)
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