NCT00718692已完成2 期
A Multi-centre, Single Intravenous Dose, Exploratory Dose-finding, Open Label Trial on the Safety and Efficacy of Sym001 in the Treatment of Immune Thrombocytopenic Purpura (ITP) in RhD Positive, Non-splenectomized Adult Subjects.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 59
- 主要终点
- Incidence and severity of Adverse Events (AEs), including Serious Adverse Events (SAEs)
研究概览
简要总结
This trial is designed as a multi-centre, single-dose, exploratory dose-finding, open label trial evaluating the safety and efficacy of Sym001 in 4-9 consecutive cohorts. Subjects will receive a single IV dose of Sym001.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Confirmed presence of thrombocytopenia with platelet count < 30,000/mm3 at the pre-dose visit.
- •History of isolated ITP
- •RhD-positive serology.
- •Previous treatment and response to first line therapy for ITP
排除标准
- •Known clinical picture suggestive of other causes of thrombocytopenia, especially systematic lupus erythematosus,antiphospholipid syndrome, Evans syndrome, immunodeficiency states, lymphoproliferative disorders, liver disease,ingestion of drugs such as quinidine/quinine, heparin and sulfonamides and hereditary thrombocytopenia confirmed by relevant laboratory findings.
- •Suspected infection with HIV, Hepatitis C, H. pylori.
- •Clinical splenomegaly
- •History of abnormal bone marrow examination.
- •Ongoing haemorrhage corresponding to a grade 3 or 4 on the WHO bleeding scale.
- •Underlying haemolytic condition
- •History of splenectomy.
- •Subject is pregnant, breast feeding or intends to become pregnant.
研究组 & 干预措施
1
Experimental
Patients treated with Sym001
干预措施: Sym001 (Drug)
结局指标
主要结局
Incidence and severity of Adverse Events (AEs), including Serious Adverse Events (SAEs)
时间窗: 6 weeks post dosing
次要结局
- Measurements of platelet counts(From day 1 through week 6)
研究者
研究点 (59)
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