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 Inc.0 个研究点目标入组 150 人开始时间: 2009年9月16日最近更新: 2014年6月2日

研究概览

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 109/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
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•`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

发起方

Amgen Inc.