EUCTR2004-000173-65-GB进行中（未招募）1 期
A Randomized, Placebo Controlled Study Evaluating the Efficacy and Safety of AMG 531 Treatment of Thrombocytopenic Subjects with Immune (Idiopathic) Thrombocytopenic Purpura (ITP) Prior to Splenectomy
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Amgen Inc
- 入组人数
- 60
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
入选标准
- •1.·Diagnosis of ITP according to American Society of Hematology (ASH) guidelines at least 3 months before enrollment
- •2. Have completed at least 1 prior treatment for ITP (eg, prednisone)
- •3. Subjects > 60 years of age must have a minimum of one year documented history of chronic ITP with a bone marrow report to confirm the diagnosis
- •4. The mean of the three platelet counts taken during the screening and pre-treatment periods must be = 30 x 109/L, with no individual count > 35 x 109/L
- •5. Subjects must be greater than or equal to 18 years of age at the time of obtaining the informed consent
- •6. A serum creatinine concentration less than or equal to 2 mg/dl (less than or equal to 176.8 mmol/L)
- •7. Adequate liver function, as evidenced by a serum bilirubin less than or equal to 1.5 times the laboratory normal range
- •8. Hemoglobin = 9.0 g/dL
- •9. Before any study-specific procedure, the appropriate written informed consent must be obtained
- •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
排除标准
- •1. Have had a Splenectomy for any reason
- •2. Any known history of 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)
- •3. Any active malignancy. If prior history of cancer other than basal cell carcinoma or cervical carcinoma in situ, no treatment or active disease within 5 years before randomization
- •4. Currently receiving any treatment for ITP, except corticosteroids, azathioprine, or danazol administered at a constant dose and schedule
- •5. IV Ig or anti-D Ig within 2 weeks before the screening visit
- •6. Rituximab (for any indication) within 14 weeks before the screening visit or anticipated use during the time of the proposed study
- •7. Received hematopoietic growth factors, including IL-11 (oprelvekin) within 4 weeks before the screening visit
- •8. Received any alkylating agents within 8 weeks before the screening visit or anticipated use during the time of the proposed study
- •9. 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 investigational agent(s) other than AMG 531
- •10. Past or present participation in any study evaluating PEG-rHuMGDF, recombinant human thrombopoietin (rHuTPO), AMG 531, or related platelet product
- •11. Subject of child-bearing potential is evidently pregnant (eg, positive HCG test) or is breast feeding
- •12. Subject is not using adequate contraceptive precautions
- •13. Known hypersensitivity to any recombinant E coli -derived product
- •14. Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with all study procedures
研究者
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