EUCTR2007-000638-37-CZ进行中（未招募）不适用
An Open Label Study of Romiplostim in Adult Thrombocytopenic Subjects with Immune (Idiopathic) Thrombocytopenic Purpura (ITP)
Amgen Inc.0 个研究点目标入组 500 人开始时间: 2008年2月11日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 500
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
- •Inclusion Criteria
- •Subject is = 18 years of age
- •Subject has a diagnosis of immune (idiopathic) thrombocytopenic purpura
- •per the American Society of Hematology guidelines
- •Subject had a bone marrow biopsy and aspirate consistent with ITP
- •conducted within 2 years of Screening
- •Subject’s platelet count is = 20 x10^9/L or the subject is experiencing bleeding
- •that is uncontrolled with conventional therapies
- •Subject has failed at least 3 conventional therapies for ITP and, in the opinion of
- •the treating physician, is unlikely to respond to other available therapies
- •If a subject has a history of atrial fibrillation, subject is currently receiving
- •anti-coagulation medication
- •Subject (or legally-acceptable representative) is willing and able to provide
- •written informed consent
- •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
- •Exclusion Criteria
- •Subject has a history of arterial thrombosis (eg, cerebrovascular accident,
- •transient ischemic attack, or myocardial infarction)
- •Subject has a history of venous thrombosis (eg, deep vein thrombosis,
- •pulmonary embolism)
- •Subject has a history of human immunodeficiency virus, hepatitis B virus, hepatitis C virus, or any other systemic infectious disease known to cause severe thrombocytopenia
- •Subject has a history of disseminated intravascular coagulation or underlying hypercoaguable state
- •Subject has a history of any of the following autoimmune disorders: systemic lupus erythematosis, Evans Syndrome, autoimmune neutropenia, lupus anticoagulant or antiphospholipid antibody syndrome, or active vasculitis
- •Subject has a history of microangiopathic hemolytic anemia (ie, hemolytic uremic syndrome, thrombotic thrombocytopenic purpura)
- •Subject has active lymphoproliferative or immunoproliferative (monoclonal
- •gammopathy of undeterimined significance, multiple myeloma) disorder or
- •Subject has a history of a myeloproliferative disorder (eg, myelofibrosis, chronic myelogenous leukemia)
- •Subject has myelodysplastic syndrome
- •Subject with a history of exposure to mutagenic chemotherapy has either dysplastic cytological findings or abnormal cytogenetics on bone marrow study
- •Subject has a history of paroxysmal nocturnal hemoglobinuria
- •Subject has participated in any study evaluating PEG-rHuMGDF, recombinant
- •human thrombopoietin (rHuTPO), or related platelet product
- •Subject has a known hypersensitivity to any recombinant E coli-derived product
- •Subject has received any therapeutic drug or device that is not approved
- •by the local regulatory health agency for any indication within 4 weeks of Screening
- •Subject is of reproductive potential and is not using adequate contraceptive
- •precautions, in the judgment of the investigator
- •Subject is pregnant or breast feeding
- •Investigator has concerns regarding the subject’s ability to comply with the protocol procedures
研究者
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