EUCTR2008-001903-42-IT进行中（未招募）不适用
An exploratory phase II dose escalation study of eltrombopag in MYH9 related disease - ND
OSPEDALE POLICLINICO S. MATTEO0 个研究点开始时间: 2008年11月11日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Age ≥ 16 years
- •- Confirmed diagnosis of MYH9RD
- •- Average platelet count for the previous year less than 50x10 exp9/L
- •- Written informed consent
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Diseases known to involve the risk of thromboembolic events (e.g. atrial fibrillation)
- •- History of thrombosis within 1 year
- •- Use of drugs that affect platelet function (including but not limited to, aspirin, clopidogrel or NSAIDS) or anti-coagulants
- •- Females who are pregnant or nursing (a negative pregnancy test in required before enrollment of fertile women)
- •- Formal refusal of any recommendation of a safe contraception
- •- Alcohol or drug addiction
- •- Altered renal function as defined by creatinine ≥ 20 mg/L
- •- Any other disease or condition that by the advise of the responsible physician would make the treatment dangerous for the patient or would make the patient ineligible for the study, including physical, psychiatric, social and behavioral problems. HCV positivity and liver diseases will not be considered an exclusion criterion since a phase II study showed that eltrombopag was effective and safe in this patient population.
研究者
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