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.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 8
- 主要终点
- Proportion of subjects achieving platelet response (Platelet response is defined as a platelet count at a scheduled weekly visit of 50000/μL or more and double the platelet count from baseline in the absence of rescue medication within the 8 weeks.)
研究概览
简要总结
Romiplostim is a novel thrombopoiesis-stimulatingprotein that has been developed as a treatment for adults with thrombocytopeniaassociated with ITP. Romiplostim provides an effective approach for thetreatment of ITP. As demonstrated in two multicentre, placebo-controlled, PhaseIII studies, Romiplostim robustly maintains platelet counts at clinicallymeaningful levels in both splenectomised and non-splenectomised patients, ascompared to patients receiving only standard of care ITP medications, withresponse rates generally better than those medications. Romiplostimhas been approved globally including US, EU, Canada, Australia etc since 2008.Romiplostim has not yet approved in India. Also, India was not the part ofInnovator’s Global clinical trial programme. Hence, safety and efficacy ofRomiplostim is unproven in Indian Population. Intas Pharmaceuticals hasdeveloped biosimilar Romiplostim, which is similar to Innovator’s product interms for chemical and preclinical characteristics. Aim of the current study isto evaluate the efficacy and safety of Intas Romiplostim in Indian population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Male and Female patients aged between 18 to 65 years (both inclusive)
- •Diagnosis of ITP according to American Society of Haematology (ASH) guidelines at least 12months before enrolment4
- •Have completed at least 1 prior treatment for ITP
- •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
- •Written informed and signed consent
- •Patient must be able to adhere to the study visit schedule, understand, and comply with all protocol requirements.
排除标准
- •History of hematological malignancy, myeloproliferative disorder, myelodysplastic syndrome (MDS), or bone marrow stem cell disorder
- •Positive test for human immunodeficiency virus (HIV) infection or hepatitis C virus
- •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
- •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
- •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
- •Received any monoclonal antibody (e.g., rituximab) within 8 weeks before the screening visit or anticipated use during the time of the proposed study
- •Less than 2 months since major surgery
- •Any other condition that in the opinion of investigator could hamper participation in the study
- •Previous participation in any clinical trial within 1 month before the entry of the study
- •Pregnant or breast feeding
- •Subjects of reproductive potential who are not using adequate contraceptive precautions, in the judgment of the investigator.
结局指标
主要结局
Proportion of subjects achieving platelet response (Platelet response is defined as a platelet count at a scheduled weekly visit of 50000/μL or more and double the platelet count from baseline in the absence of rescue medication within the 8 weeks.)
时间窗: Baseline to week 8
次要结局
- •Dose required to achieve targeted platelet count (50000/μL)(•Proportion of patients with at least one dose increment)