EUCTR2004-004058-20-ES进行中（未招募）1 期
A phase II, open-label, multicentre, pharmacokinetic, pharmacodynamic and safety study of anagrelide hydrochloride in young (18-50 years) and elderly (= 65 years) patients with essential thrombocythaemia.
Shire Pharmaceutical Development Limited0 个研究点目标入组 24 人开始时间: 2006年5月18日最近更新:
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相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 24
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
- •Young patients aged 18-50 years inclusive.
- •Elderly patients aged 65 years and over.
- •Patients must have a confirmed diagnosis of ET.
- •Currently receiving anagrelide hydrochloride at a stable maintenance dose = 5 mg/day for at least 4 weeks.
- •Body Mass Index (BMI) in the range 16-30 (calculated according to Quetlets method).
- •Free of active infection.
- •Adequate renal function (creatinine clearance in the range 97-137 ml/min (male) and 88-128 ml/min (female)).
- •Adequate hepatic function (Aspartate amino transferase (AST) and bilirubin = 1.5 x upper limit of normal).
- •Performance status 0 or 1 (World Health Organisation (WHO) criteria) with a life expectancy of > 4 months.
- •Are the trial subjects under 18? no
- •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
- •Diagnosis of any other myeloproliferative disorder.
- •A resting ejection fraction below the limit of the laboratory normal.
- •Current use of tobacco in any form (e.g. smoking or chewing).
- •Standard blood donation (one pint or more) within 30 days prior to study initiation.
- •Plasma donation within 7 days prior to study initiation.
- •Abnormal diet or changes in eating habits (per investigator discretion) within 30 days prior to study initiation.
- •Treatment with any known enzyme altering agents (barbiturates, phenothiazines, cimetidine etc.) within 30 days prior to or during the study.
- •Positive urine pregnancy test (for females of child bearing potential) at screening or baseline.
- •Patients for whom use of another cytoreductive agent in addition to anagrelide is considered necessary for control of platelet count.
研究者
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