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临床试验/NCT00128882
NCT00128882已完成2 期

Treatment of Idiopathic Thrombocytopenic Purpura in Children With Subcutaneously Administered Anti-D

University of Aarhus34 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2004年11月最近更新:
适应症
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
45
试验地点
34
主要终点
Clinical effect evaluated on clinical score scale before and after treatment at specified intervals

研究概览

简要总结

The purpose of this study is to describe the effect of anti-D on symptoms and platelet count in children suffering from unexplainable low platelet counts, when anti-D is administered as an injection under the skin. The hypothesis is that the injection with anti-D under the skin is as effective as anti-D given in a vein.

详细描述

Background:

Idiopathic thrombocytopenic purpura (ITP) in children is considered a benign hematological disease. The incidence is approximately 50 cases a year in Denmark. Approximately 25 % will experience chronic disease. Follow up and treatment of these patients is not centralized.

The drug of choice is intravenous IgG (IVIG) for treatment of ITP. The side effects are flu-like symptoms, and in rare cases aseptic meningitis. Another option is intravenous anti-D, if the child is rhesus positive. Anti-D is primarily used in North America. The effect of Anti-D is comparable with IVIG when considering the time it takes to bring the platelet count above 50,000/μL. Anti-D also causes flu-like symptoms. Establishing an i.v. access is a disadvantage to both IVIG and anti-D. For both treatments mechanism of action is not finally described.

Subcutaneous IgG substitution therapy is used for patients suffering from agammaglobulinaemia. It is therefore known, that immunoglobulin uptake is possible after subcutaneous administration. Subcutaneous anti-D has been tried in few patients suffering from chronic thrombocytopenia with positive results.

IVIG treatment is expensive compared to anti-D. Treatment of a 20 kg child costs approximately 17,000 Dkr for IVIG and 2,500 Dkr. for anti-D.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
1 Year 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Idiopathic thrombocytopenic purpura (ITP)

排除标准

  • 未提供

结局指标

主要结局

Clinical effect evaluated on clinical score scale before and after treatment at specified intervals

时间窗: day 0,1,3,6,14,30, 180,360

次要结局

  • Platelet count(day 0, 1, 3, 6, 14, 30, 180, 360)

研究者

申办方类型
Other

研究点 (34)

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