A Prospective, Phase IV, Open-Label, Multi-Center Study Evaluating Changes in Bone Marrow Morphology in Adult Subjects Receiving Romiplostim for the Treatment of Thrombocytopenia Associated with Immune (Idiopathic) Thrombocytopenia Purpura (ITP)

Amgen Inc0 个研究点目标入组 150 人开始时间: 2009年9月17日最近更新: 2014年3月10日

适应症

试验速览

暂无简介。

•Diagnosis of ITP according to the American Society of Hematology (ASH) guidelines
•Subject must have had a bone marrow biopsy within one year prior to planned first dose of romiplostim (with available bone marrow tissue block or unstained histological slides to send to a central laboratory for interpretation) or must consent to a pre-treatment bone marrow biopsy within 3 weeks prior to planned first dose of romiplostim. Central laboratory interpretation is required prior to first dose of romiplostim
•Baseline bone marrow reticulin grade of 0, 1, 2 or 3 according to the modified Bauermeister grading scheme as assessed by central laboratory interpretation
•Subject must agree to a scheduled bone marrow biopsy at Year 1, Year 2, or Year 3 following romiplostim treatment and any unscheduled biopsies if clinically indicated
•Subject platelet count is < 50x 10*9/L
•Subject =18 years of age
•Must have received at least 1 prior ITP therapy (examples of ITP therapy include corticosteroids, IVIG, splenectomy)
•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: 0
•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

•Baseline bone marrow biopsy positive for collagen fibrosis
•Any known history of or currently active bone marrow stem cell disorder, hematological malignancy, myeloproliferative disorder, or myelodysplastic syndrome
•Any current active malignancy
•Any prior exposure to cytostatic chemotherapy or radiotherapy for malignancy
•Subject has undergone pacemaker placement, cardiac ablation of arrhythmia, and/or any current treatment with Vaughan Williams Class IA – IC and Class III agents
•Subject has participated in any study evaluating PEG-rHuMGDF, recombinant human thrombopoietin (rHuTPO), or thrombopoietin receptor agonists (ie romiplostim or eltrombopag)
•Subject has a known hypersensitivity to any recombinant E coli-derived product
•Subject is currently enrolled in or has not yet completed (at least 4 weeks since ending) other investigational device or drug trial(s) or subject is receiving other investigational agent(s)
•Other investigational procedures are excluded
•Subject of child-bearing potential is evidently pregnant (eg, positive pregnancy test) or is breast feeding
•Subject is not using adequate contraceptive precautions
•Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and does not have a legally acceptable representative and/or is unable to comply with study procedures

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