EUCTR2013-004328-12-DE进行中（未招募）1 期
Prospective validation of a predictive model of response to romiplostim in patients with IPSS low or intermediate-1 risk myelodysplastic syndrome (MDS) and thrombocytopenia - the EUROPE-trial - Europe
GMIHO Gesellschaft für Medizinische Innovation - Hämatologie und Onkologie mbH0 个研究点目标入组 75 人开始时间: 2014年10月8日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 75
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
- •Subjects must meet the following inclusion criteria tobe eligible for the study,
- •1.Must understand and voluntarily sign an informed consent form
- •2.Age > 18 years at the time of signing the informed consent form
- •3.Must be able to adhere to the study visit schedule and other protocol requirements
- •4.Diagnosis of MDS using the WHO classification for myeloid neoplasms (Vardiman et al, 2002) as assessed during the screening period
- •5.Per MDS IPSS, low or intermediate-1 risk MDS as assessed during the screening period
- •6.The mean of the 2 platelet counts taken within 4 weeks prior to stratification must be:
- •= 30 x 109/L (with no individual count > 30 x 109/L during the screening period), with or without a history of bleeding associated with the diagnosis of MDS, OR
- •< 50 x 109/L (with no individual count >60 x 109/L during the screening period), with a history of bleeding associated with the diagnosis of MDS
- •(A standard of care platelet count taken prior to Informed consent may be used as 1 of the 2 counts taken within 4 weeks prior to randomization)
- •7.Adequate liver function, as evidenced by ALT = 3 times the laboratory normal range, AST = 3 times the laboratory normal range and total bilirubin = 2 times the laboratory normal range
- •8.Bone marrow aspirate (central diagnostics) with cytogenetics (local) within 8 weeks of starting first dose of investigational product
- •9.Female subjects of childbearing potential† must:
- •oAgree to use, and be able to comply with, effective contraception without interruption, 4 weeks before starting study drug, throughout study drug therapy and for 4 weeks after the end of study drug therapy, even if she has amenorrhoea
- •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 75
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 75
排除标准
- •1.Pregnant or lactating females
- •2.IPSS intermediate-2 or high-risk
- •3.= 5% blasts in the bone marrow as determined by central morphology during screening
- •4.Previous treatment with any thrombopoietic growth factor
- •5.Prior history of hematopoietic stem cell transplantation
- •6.Active or uncontrolled disease including infections or cancer
- •7.Unstable angina, congestive heart failure (NYHA > class II), uncontrolled hypertension
- •8.History of arterial thrombosis (eg, stroke or transient ischemic attack) within the past year
- •9.History of venous thrombosis that currently requires anti-coagulation therapy
- •10.Received IL-11 within 4 weeks of the first dose of investigational product
- •11.Receipt of G-CSF, peg-G-CSF, or GM-CSF within 4 weeks of the first dose of investigational product
- •12.Planned receipt of peg-G-CSF or GM-CSF after the first dose of investigational product
- •13.Subjects of reproductive potential who are not using adequate contraceptive precautions, in the judgment of the investigator. The sponsor recommends double barrier contraception is used for all applicable patients enrolled on this study. A double barrier method is defined as 2 methods of contraception, for example 2 actual barrier methods, or 1 actual barrier method and 1 hormonal method.
- •14.Known hypersensitivity to any recombinant E coli-derived product (eg, Infergen?, Neupogen?, Somatropin, and Actimmune)
- •15.Inability to comply with study procedures.
- •16.Subject currently is enrolled in or has not yet completed at least 30 days since ending other investigational device or drug study(s)
- •17.Any serious medical condition or psychiatric illness that will prevent the subject from signing the informed consent form or will place the subject at unacceptable risk if he/she participates in the study.
研究者
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