NCT01443351撤回不适用
Long-term Safety Study of Treatment With the Thrombopoietin Agonists Eltrombopag and Romiplostim in Patients With Primary Immune Thrombocytopenia (ITP)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Number of patients with sustained response at 6 months follow-up
研究概览
简要总结
Thrombopoietin Receptor Agonists (TPO-ra) are novel treatment modalities for patients with refractory Primary Immune Thrombocytopenia (ITP), but only few data are available for long-term effects of these drugs. In this observational study, effects and adverse effects including evaluation of bone marrow biopsies done at fixed intervals will be recorded from ITP patients treated with TPO-ra. For some patients, blood samples will be collected for research use.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Adult patients with ITP
- •platelet counts < 25 x10*9/L or < 50 x10*9/L with bleeding symptoms
- •meets criteria for treatment with TPO-ra
- •Females must use contraceptives when applicable for at least three months before inclusion
排除标准
- •Pregnancy or nursing
- •Former thromboembolic events excluding one incidence of deep venous thrombosis as complication to surgery or pregnancy or one incidence of cerebral embolism as complication to atrial fibrillation
- •Liver insufficiency (for eltrombopag only)
- •TPO-ra contraindications (e.g. allergy)
- •TPO-ra treatments less than 6 months prior to inclusion
结局指标
主要结局
Number of patients with sustained response at 6 months follow-up
时间窗: 6 months
Response is defined as platelet count \> 30.000 mio/L and no bleeding
次要结局
- Yearly response rates(5 years)
- Frequency of relapse(5 years)
- Rate of splenectomy(5 years)
- Development of reticulin fibrosis in bone marrow biopsies(5 years)
研究者
Sif Gudbrandsdottir
MD
Zealand University Hospital
研究点 (1)
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