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3月4日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•Inclusion Criteria
•Subject is = 18 years of age
•Subject has a diagnosis of immune (idiopathic) thrombocytopenic purpura
•per the American Society of Hematology guidelines
•If subject is > 60 years of age, subject has a written bone marrow aspiration and/or biopsy report consistent with a diagnosis of ITP
•Subject has received at least 1 prior therapy for ITP
•Subject’s platelet count is = 30 x10^9/L or the subject is experiencing bleeding
•that is uncontrolled with conventional therapies
•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

•Exclusion Criteria
•Subject has a history of hematological malignancy, myeloproliferative disorder, MDS, or bone marrow stem cell disorder
•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

发起方

Amgen Inc.