A phase IV, open-label, single-arm, multi-center clinical study to evaluate the safety and efficacy of romiplostim in patients with chronic immune thrombocytopenic purpura.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 7
- 主要终点
- Number of AEs (adverse events) and Number of adverse drug
研究概览
简要总结
This study will be conducted to evaluate the safety and efficacy of romiplostim in patients with chronic immune thrombocytopenic purpura. Sufficient number of patients will be enrolled in the study to get 25 evaluable subjects. Patient’s who meet all inclusion criteria and none of the exclusion criteria based on medical history will be recruited in the study. Patient’s visit 1 will be screening visit followed by treatment period and last will be follow up period for 1 week after last dose.
The eligible patient’s will be injected subcutaneously with initial dose for Romiplostim 1 mcg/kg based on actual body weight and then the weekly dose of Romiplostim will be adjusted by increment of 1 mcg/kg until the patient achieves a platelet count more than or equal to 50 count once a week for 12 cycles. The primary endpoint will be number of AEs (adverse events) and number of adverse drug reactions (ADRs) during the study period. The secondary endpoint will be number of serious adverse events (SAEs) and serious adverse drug reactions (SADRs) during the study period and proportion of patients achieving platelet response (achievement of a weekly platelet count more than or equal to 50 x 10 raise to 9 /L).
研究设计
- 研究类型
- Observational
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 subject in between 18 to 65 years of age. 2) Patients with chronic immune (idiopathic) thrombocytopenic purpura. per the American Society of Hematology guidelines. 3) If subject is > 60 years of age, subject had a written bone marrow biopsy report consistent with a diagnosis of ITP. 4) Subject had received at least 1 prior therapy for ITP. 5)Subject with a single platelet count less than equal to 30 x 10 raise to 9/L at any time during the screening period. 6) Subject (or legally.
- •acceptable representative) was willing and able to provide written informed consent.
排除标准
- •Known hypersensitivity to romiplostim or any of its excipients.
- •Subject had a history of hematological malignancy, myeloproliferative disorder, myelodysplastic syndrome (MDS), or bone marrow stem cell disorder.
- •Subjects with known history of congenital thrombocytopenia, systemic lupus erythematosus, Evans syndrome, autoimmune neutropenia, antiphospholipid antibody syndrome, positive for lupus anticoagulant, disseminated intravascular coagulation, hemolytic uremic syndrome, or thrombotic thrombocytopenic purpura.
- •Subjects with known history of infection with H.
- •Previous use of romiplostim, pegylated recombinant human megakaryocyte growth and development factor (PEG-rHuMGDF), Eltrombopag, recombinant human thrombopoietin (rHuTPO) or any platelet producing agent.
- •Subject has a known hypersensitivity to any recombinant E coli-derived product.
- •Subjects suffering from chronic liver disease (Child-Pugh score more than or equal to 7).
- •Subjects with history of any thromboembolic disease.
- •Subject is of reproductive potential and is not using adequate contraceptive precautions, in the judgment of the investigator.
- •Subject is pregnant or breast feeding.
- •Any significant medical condition in the opinion of the investigator that does not allow the participation of the patient in the study.
结局指标
主要结局
Number of AEs (adverse events) and Number of adverse drug
时间窗: 14 weeks
reactions (ADRs) during the study period
时间窗: 14 weeks
次要结局
- Number of serious adverse events (SAEs) and serious adverse drug reactions (SADRs) during the study period.(14 weeks)
- Proportion of patients achieving platelet response (achievement of a weekly platelet count more than or equal to 50 x 10 raise to 9 /L)(14 weeks)