A Phase IIIb, Randomized, Open Label Study to Compare the Safety, Efficacy and Tolerability of Anagrelide Hydrochloride Versus Hydroxyurea in High-Risk Essential Thrombocythaemia Patients.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Shire
- 入组人数
- 150
- 试验地点
- 15
- 主要终点
- Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Over Time
研究概览
简要总结
Essential thrombocythaemia is a disorder of bone marrow, which causes too many platelets to be produced. Platelets are small cells carried around in the blood, which help form blood clots. When patients have too many platelets, there is a risk of blood clots forming unnecessarily and excessive bleeding. The aim of this study is to gain additional information on the safety profile of Anagrelide (Xagrid(r)) and Hydroxyurea (also known as hydroxycarbamide).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 diagnosis of essential thrombocythaemia - high risk profile
- •Previously untreated with a cytoreductive agent
- •Females of childbearing potential must have a negative urine pregnancy test prior to entering the study and must agree to use effective birth control for the duration of the study
排除标准
- •Diagnosis of any other myeloproliferative disorder
- •Any known cause for a secondary thrombocytosis
- •Anti-coagulant and anti-aggregant therapies
- •Known or suspected heart disease
- •Left Ventricular Ejection Fraction < 55%
研究组 & 干预措施
A
干预措施: Anagrelide (Drug)
B
干预措施: Hydroxyurea (Drug)
结局指标
主要结局
Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Over Time
时间窗: Baseline and Month 1, 2, 3, 6, 9, 12, 18, 24, 30 and 36
The LVEF was measured by echocardiography and considered a sufficiently sensitive measure to evaluate any changes in cardiac function.
Platelet Count at Month 6
时间窗: Month 6
Platelet count was evaluated.
次要结局
- Percentage of Participants With Partial Response(Baseline up to Month 36)
- Change From Baseline in Red Blood Cell Count Over Time(Baseline and Month 6, 12, 18, 24, 30 and 36)
- Change From Baseline in Platelet Counts at Month 3 and 36(Baseline and Month 3 and 36)
- Percentage of Participants With Complete Response(Baseline up to Month 36)
- Time to Partial Response(Baseline up to Month 36)
- Number of Participants With Thrombotic and Haemorrhagic Events(From the signing of informed consent until the last study-related visit (Month 36))
- Time to Complete Response(Baseline up to Month 36)
- Change From Baseline in White Blood Cell Count Over Time(Baseline and Month 6, 12, 18, 24, 30 and 36)