A Phase 3 Randomized, Double Blind, Placebo Controlled Study to Determine the Safety and Efficacy of Romiplostim in Thrombocytopenic Pediatric Subjects with Immune Thrombocytopenia (ITP)

Amgen Inc.0 个研究点目标入组 60 人开始时间: 2014年9月9日最近更新: 2014年10月7日

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方
入组人数: 60

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

•Diagnosis of primary ITP according to the ASH Guidelines at least 6 months prior to screening, regardless of splenectomy status
•Subject must be refractory to a prior ITP therapy, having relapsed after at least 1 prior ITP therapy, or ineligible for other ITP therapies
•-Prior therapy includes first-line therapies
•Age = 1 year and < 18 years at the time of providing informed consent
•The mean of 2 platelet counts taken during the screening period must be
•= 30 x 109/L with neither count > 35 x 109/L
•A serum creatinine concentration = 1.5 times the laboratory normal range (for each age category) during the screening period
•Adequate liver function;
•-serum bilirubin = 1.5 times the laboratory normal range during the
•screening period
•-AST and ALT = 3.0 times the laboratory normal range during the
•screening period
•Hemoglobin > 10.0 g/dL during the screening period
•Subject and/or subject’s legally acceptable representative has provided informed consent prior to any study-specific procedure; subject has provided assent, where required
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 60
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

排除标准

•Known history of a bone marrow stem cell disorder
•-Any abnormal bone marrow findings other than those typical of ITP must be approved by Amgen before a subject may be enrolled in the study
•Known active or prior malignancy except adequately treated basal cell carcinoma
•Known history of congenital thrombocytopenia
•Known history of hepatitis B, hepatitis C, or HIV
•Known history of H. pylori by urea breath test or stool antigen test within 6 months of enrollment or successfully treated with no evidence of infection
•Known history of systemic lupus erythematosus, evans syndrome, or autoimmune neutropenia
•Known history of antiphospholipid antibody syndrome or positive for lupus anticoagulant
•Known history of disseminated intravascular coagulation, hemolytic uremic syndrome, or thrombotic thrombocytopenic purpura
•Previous history of venous thromboembolism or thrombotic events
•Previous use of romiplostim, PEG-rHuMGDF, Eltrombopag, rHuTPO or any platelet producing agent
•Rituximab (for any indication) or 6-MP within 14 weeks before the screening visit, or anticipated use during the time of the proposed study
•Splenectomy within 4 weeks of the screening visit
•All hematopoietic growth factors including IL-11 (oprelvekin) within 4 weeks before the screening visit
•Alkylating agents within 8 weeks before the screening visit or anticipated use during the time of the proposed study
•Vaccinations known to decrease platelet counts within 8 weeks before the screening visit
•Known hypersensitivity to any recombinant E coli-derived product (eg, Infergen, Neupogen, Somatropin, and Actimmune)
•Currently enrolled in another investigational device or drug study, or less than 30 days since ending another investigational device or drug study(s), or receiving other investigational agent(s)
•Subject will have any other investigational procedures performed while enrolled in this clinical study
•Subject is pregnant or breast feeding, or planning to become pregnant within
•1 month after the end of treatment
•Female subject of child bearing potential is not willing to use, in combination with her partner, 2 forms highly effective contraception during treatment and for 1 month after the end of treatment
•Subject has known sensitivity to any of the products to be administered during dosing
•Subject has previously enrolled into a prior Amgen romiplostim study
•Subject will not be available for protocol-required study visits, to the best of the subject’s and investigator’s knowledge
•Subject has any kind of disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and/or to comply with all required study procedures

研究者

发起方

Amgen Inc.

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