A Randomized, Controlled, Open- label Study Evaluating the Efficacy and Tolerability of AMG 531 versus Medical Standard of Care as Chronic Therapy for Non-splenectomized Subjects with Immune (Idiopathic) Thrombocytopenic Purpura

Amgen Inc.0 个研究点目标入组 210 人开始时间: 2007年2月6日最近更新: 2012年3月19日

适应症

试验速览

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•- Subject is = 18 years of age.
•- Subject has a diagnosis of ITP according to ASH guidelines.
•- If subject is > 60 years of age, subject has a written bone marrow biopsy report confirming the diagnosis of ITP.
•- Subject has received at least 1 prior therapy for ITP.
•- Subject has a platelet count < 50 x 109/L or their platelet count falls to < 50 x 109/L during or after a clinically- indicated taper or discontinuation of current ITP therapy.
•- Before any study- specific procedure, the appropriate written informed consent must be obtained (see Section 12.1).
•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

•- Subject has had a splenectomy for any reason.
•- Subject has an active malignancy.
•- Subject has a history of cancer, other than basal cell carcinoma or cervical carcinoma in situ, with treatment or active disease within 5 years.
•- Subject has a known history of bone marrow stem cell disorder,
•Abnormal bone marrow findings, other than those typical of ITP, must be approved by Amgen before a subject may be enrolled in the study.
•- Subject has participated in any study evaluating PEG- rHuMGDF, recombinant human thrombopoietin (rHuTPO), AMG 531, or a thrombopoietic protein.
•- Subject is receiving other investigational agents or procedures.
•- Subject is currently enrolled in, or has completed within the last 30 days, another investigational device or drug study.
•- Subject is pregnant or breast feeding.
•- Subject is not using adequate contraceptive precautions.
•- Subject has known sensitivity to any recombinant E coli- derived product.
•- 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.
•- Subject has any kind of disorder that compromises the ability of the subject to comply with study procedures.

发起方

Amgen Inc.