CTRI/2015/09/006197已完成3 期
A Prospective, Open-label, Multi-centric Study to Evaluate the Efficacy and Safety of Inj. Romiplostim of Intas Pharmaceuticals Ltd. in Adult Indian Patients with Chronic Refractory Idiopathic Thrombocytopenic Purpura. - NA
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Male and Female patients aged between 18 to 65 years (both inclusive)
- •2. Diagnosis of ITP according to American Society of Haematology (ASH) guidelines at least 12months before enrolment4
- •3. Have completed at least 1 prior treatment for ITP
- •4. Value of platelet count must be: (i) less than 30000/μL for those patients not receiving any ITP therapy (ii) less than 50000/μL for those patients receiving a constant dose schedule of corticosteroids
- •5. Written informed and signed consent
- •6. Patient must be able to adhere to the study visit schedule, understand, and comply with all protocol requirements.
排除标准
- •1. History of hematological malignancy, myeloproliferative disorder, myelodysplastic syndrome (MDS), or bone marrow stem cell disorder
- •2. Positive test for human immunodeficiency virus (HIV) infection or hepatitis C virus
- •3. Currently receiving any treatment for ITP except oral corticosteroids, azathioprine and/or danazol administered at a constant dose and schedule from at least 4 weeks prior to the screening visit
- •4. Received intravenous immunoglobulin, anti-D immunoglobulin, or any drug administered to increase platelet counts (e.g., immunosuppressants etc) within 1 week before the screening visit
- •5. Received hematopoietic growth factors (e.g., granulocyte colony stimulating factor, macrophage colony stimulating factor, erythropoietin, interleukin 11) for any reason within 4 weeks before the screening visit
- •6. Received any monoclonal antibody (e.g., rituximab) within 8 weeks before the screening visit or anticipated use during the time of the proposed study
- •7. Less than 2 months since major surgery
- •8. Any other condition that in the opinion of investigator could hamper participation in the study
- •9. Previous participation in any clinical trial within 1 month before the entry of the study
- •10. Pregnant or breast feeding
- •11. Subjects of reproductive potential who are not using adequate contraceptive precautions, in the judgment of the investigator
研究者
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