EUCTR2012-004886-42-GR进行中（未招募）1 期
Study of the effect of the thrombopoietin receptor agonist eltrombopag on thrombocytopenia and megakaryopoiesis of patients with lower and intermediate-1 risk myelodysplastic syndromes.
niversity of Crete0 个研究点目标入组 45 人开始时间: 2013年3月19日最近更新:
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
- 45
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
- •1.Adult subjects (= 18 years old) with low and intermediate-1 MDS type according to the WHO classification and IPSS.
- •2.Mean baseline platelet count <30x Gi/L or <50 Gi/L with bleeding manifestations.
- •3.Patients with data on platelet count, bleeding and platelet transfusions covering a period of at least 4 weeks before enrolment.
- •4.Bone marrow examination 4 weeks before randomization.
- •5.Supportive/palliative therapies such as cytokines (except for IL-11; oprelvekin), valproic acid and all-trans retinoic acid are allowed, provided those therapies have been at a stable dose for 4 weeks or were completed 4 weeks prior to enrolment into this study.
- •6.ECOG Status 0-2.
- •7.Adequate baseline liver and renal function defined by the criteria below:
- •total bilirubin (except for Gilbert’s Syndrome) = 1.5xULN
- •ALT and AST = 3xULN
- •serum creatinine = 1.5mg/dl or calculated creatinine clearance = 40ml/min (calculated buy the Cockcroft and Gault Method)
- •8.Prothrombin time (PT/INR) and activated partial thromboplastin time (aPTT) must be within 80%-120% of the normal range at baseline.
- •9.Subject is practicing an acceptable method of contraception. Negative pregnancy test within 7 days of dosing.
- •10.Subject is able to understand and comply with protocol requirements and instructions.
- •11.Written informed consent according to the Helsinki Declaration.
- •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 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 25
排除标准
- •1.Subjects with intermediate-2 and high-risk MDS type according to the WHO classification and IPSS.
- •2.Patients not eligible for platelet transfusions.
- •3.Treatment with epigenetic or immunosuppressive therapy within 6 weeks of screening.
- •4.History of treatment for cancer with systemic chemotherapy and/or radiotherapy within the last 12 months.
- •5.History of treatment with romiplostim or other TPO-R agonists.
- •6.Pre-existing cardiovascular disease (including heart failure) or arrhythmia known to increase the risk of thromboembolic events (e.g. atrial fibrillation) or subjects with a QTc> 450 msec.
- •7.Bone marrow fibrosis that leads to an inability to aspirate marrow for assessment.
- •8.Subjects with Spleen size >16 cm.
- •9.Leukocytosis (>=25000 uL) prior to day 1 of treatment.
- •10.Subjects with known thrombophilic risk factors. Exception: Subjects for whom the potential benefits of participating in the study outweigh the potential risks of thromboembolic events, as determined by the investigator.
- •11.Previous treatment or known or suspected hypersensitivity to eltrombopag or its components.
- •12.Pregnant or lactating women. Women of childbearing potential must have a negative pregnancy test which is to be performed within 7 days of dosing.
- •13.Women of childbearing potential, including women whose last menstrual period was less than one year prior to screening, unable or unwilling to use adequate contraception from study start to one year after the last dose of protocol therapy. Adequate contraception is defined as abstinence, oral hormonal birth control, hormonal birth control injections, implants of etonogestrel or levonorgestrel, estrogenic vaginal ring, percutaneous contraceptive patches, intrauterine device, male partner sterilization if male partner is sole partner for that patient and male condom combined with a female diaphragm, either with or without a vaginal spermicide.
- •14.Male subjects unable or unwilling to use adequate contraception methods from study start to one year after the last dose of protocol therapy.
- •15.Current alcohol or drug abuse.
- •16.Treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the 1st dose of study medication.
- •17.Active and uncontrolled infections.
- •18.Subjects infected with HepB, HepC or HIV.
- •19.Subjects with liver cirrhosis.
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