A Randomized Double Blind, Placebo Controlled Study Evaluating the Efficacy and Safety of Romiplostim Treatment of Thrombocytopenia in Subjects with Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS)

Amgen Inc0 个研究点目标入组 240 人开始时间: 2008年7月8日最近更新: 2016年4月11日

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方: Amgen Inc
入组人数: 240

研究概览入排标准研究者记录与标识符相似试验

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

•Disease related:
•Diagnosis of MDS using the WHO classification for myeloid neoplasms (Vardiman et al, 2002) as assessed during the screening period
•Per MDS IPSS, low or intermediate-1 risk MDS as assessed during the screening period
•The mean of the 2 platelet counts taken within 4 weeks prior to randomization must be:
•= 20 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.
•Demographic:
•Subjects must be =18 and = 90 years of age at the time of informed consent. Subjects between 85 and 90 years of age must have been diagnosed with MDS = 5 years from study start.
•Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
•Laboratory:
•Adequate liver function, as evidenced by ALT = 3 times the laboratory normal range, AST = 3 times the laboratory normal range and total bilirubin = 2.0 times the laboratory normal range.
•(Adequate liver function for patients with a confirmed diagnosis of Gilbert’s Disease evidenced by ALT = 3 times the laboratory normal range and AST = 3 times the laboratory normal range).
•A serum creatinine concentration = 2 mg/dl (=176.8 µmol/L)
•Bone marrow biopsy and aspirate with cytogenetics within 3 months of the first dose of investigational product.
•Before any study-specific procedure, the appropriate written informed consent from the subject or his/her legally acceptable representative must be obtained.
•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

•Disease Related:
•Have ever received any disease-modifying treatment for MDS (for a list of disease - modifying treatments please refer to section 6.5)
•Previously diagnosed with intermediate-2 or high risk MDS with IPSS
•Prior history of leukemia, aplastic anemia, or other non-MDS related bone marrow stem cell disorder
•Prior history of hematopoietic stem cell transplantation
•Persistent peripheral blood monocytosis (= 3 months with an absolute monocyte count > 1,000/µL) or known diagnosis of Chronic Myelomonocytic Leukemia per the FAB criteria (Bennett, et al, 1976)
•Prior malignancy (other than in situ cervical cancer, non-melanoma skin cancer, or in situ carcinoma) unless treated with curative intent and without evidence of disease for =3 years before randomization
•Active or uncontrolled infections
•Unstable angina, congestive heart failure (NYHA > class II), uncontrolled hypertension (diastolic > 100 mmHg), uncontrolled cardiac arrhythmia, or recent (within 1 year) myocardial infarction
•History of arterial thrombosis (eg, stroke or transient ischemic attack) in the past year
•History of venous thrombosis that currently requires anti-coagulation therapy
•Laboratory:
•Pregnant or breast feeding
•Medications
•Received IL-11 within 4 weeks of the first dose of investigational product
•Have previously received any thrombopoietic growth factor
•Receipt of G-CSF, peg-G-CSF, or GM-CSF within 4 weeks of the first dose of investigational product.
•Planned receipt of peg-G-CSF or GM-CSF after the first dose of investigational product.
•Subject of reproductive potential who is not using adequate contraceptive precautions, in the judgement of the investigator. Amgen recommends double barrier contraception is used for all applicable patients enrolled on this study. A double barrier method is defined as two methods of contraception, for example 2 actual barrier methods, or one actual barrier method and one hormonal method.
•Subject has known sensitivity to any E coli-derived product (eg, Infergen®, Neupogen®, Somatropin, and Actimmune®).
•Previously enrolled into the 20060198 study or another romiplostim study
•Inability to comply with study procedures.
•Subject currently is enrolled in or has not yet completed 30 days since ending other investigational device or drug study.

研究者

发起方

Amgen Inc

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