NCT05220878已完成3 期
Multicenter Randomized Double-blind Comparative Study of Clinical Efficacy and Safety of GNR-069 (JSC "GENERIUM", Russia) and Nplate (Amgen Europe BV, The Netherlands) in Patients With Idiopathic Thrombocytopenic Purpura
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AO GENERIUM
- 入组人数
- 160
- 试验地点
- 35
- 主要终点
- Proportion of patients achieving sustained response to treatment
研究概览
简要总结
It is a phase III multicenter randomized double-blinded comparative study of clinical efficacy and safety of GNR-069 and Nplate in patients with idiopathic thrombocytopenic purpura
详细描述
The drug GNR-069(JSC "GENERIUM", Russia) is biosimilar to the original drug Nplate. This study is aimed to compare the clinical efficacy and safety of the drug GNR-069 and the drug Nplate to register of the drug GNR-069 in the Russian Federation for therapy in patients with idiopathic thrombocytopenic purpura (ITP). The study also provides for the evaluation of pharmacokinetic parameters and immunogenicity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Double-blinded
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written Informed Consent Form to participate in the study;
- •Men and women aged 18-75 years inclusive at the time of signing the Informed Consent Form;
- •Documented diagnosis of ITP with a disease duration of more than 12 months from the moment of confirmation of the diagnosis by bone marrow aspirate or biopsy results;
- •A. For patients who have not had splenectomy:
- •established absence/loss of response to therapy with at least one drug of fist-line treatment for ITP (which include GCs an IVIG); OR
- •the occurrence of side effects during the course of therapy with the drug of the fist-line, making it impossible to use it further;
- •B. For patients who underwent splenectomy:
- •loss/lack of response to splenectomy;
- •Thrombocytopenia ≥30.0 x 109/L - <50.0 x 109/L with severe hemorrhagic syndrome or thrombocytopenia <30.0 x 109/l, regardless of the presence of hemorrhagic syndrome, according to the results of platelet count conducted in a local laboratory for 7 days before the start of therapy with investigational or reference drug;
- •Patients receiving GCs, azathioprine and danazole should receive these drugs in a maintenance dose for at least 4 weeks before starting therapy with investigational or reference drug;
- •Consent of study participants with preserved childbearing function to use reliable methods of contraception (a combination of at least two methods, including 1 barrier method, for example, the use of a condom and spermicide) from the moment of signing the Informed Consent Form and 3 months after the last administration of investigational or reference drug.
排除标准
- •Hypersensitivity to the components of investigational or reference drug or E. coli proteins ;
- •Unresolved severe hemorrhagic syndrome requiring emergency treatment at the time of initiation of study or reference drug therapy ;
- •Fisher-Evans Syndrome;
- •Conditions with a high risk of thromboembolic complications ;
- •Myelodysplastic syndrome and/or bone marrow transplantation in anamnesis;
- •Deviations of clinical and laboratory parameters according to the results of studies of blood samples taken during the screening period;
- •Positive test results for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV);
- •Pregnancy or breastfeeding;
- •Use of drugs:
- •romiplostim used less than 3 weeks before treatment with study or reference drug;
- •IVIG - less than 2 weeks prior to initiation of study or reference drug therapy;
- •eltrombopag - used less than 2 weeks before treatment with study or reference drug, or planned to use eltrombopag while the patient is participating in this study;
- •rituximab - used less than 14 weeks before treatment with study or reference drug, or planned to use rituximab while the patient is enrolled in this study;
- •cyclophosphamide, cyclosporine, vincristine, vinblastine and other drugs used to treat ITP not listed above and not included in the list of drugs approved for use during the study - use less than 8 weeks before the start of therapy with the study or reference drug or the use of any of these drugs is planned during the patient's participation in this study;
- •preparations of any hematopoietic growth factors - use less than 8 weeks before the start of therapy with an investigational or reference drug;
- •Influenza vaccines - less than 21 days prior to start of treatment with study or reference drug;
- •vaccines to prevent novel coronavirus disease (COVID-19) - completion of the vaccination program less than 21 days prior to the start of study or reference drug therapy;
- •other vaccines - less than 8 weeks prior to start of treatment with study or reference drug;
- •Splenectomy within 12 weeks prior to screening;
- •Participation in any clinical trials and/or use of unregistered drugs within 4 weeks prior to screening or 5 drug half-lives (whichever is greater);
- •Any other disease or condition that, in the opinion of the investigator, may preclude the patient from participating in the study.
结局指标
主要结局
Proportion of patients achieving sustained response to treatment
时间窗: 26 weeks
A sustained response to treatment is defined as the number of platelets ≥ 50.0 x 109/L for at least 9 out of 12 consecutive visits during the treatment period with the study or reference drug.
次要结局
- Number of cases of emergency therapy for severe hemorrhagic syndrome during the treatment period, starting from the second week of therapy with the investigational or reference drug(25 weeks)
- Proportion of patients with no/loss of response to treatment with investigational or reference drug(26 weeks)
- Proportion of patients who achieve stable platelet count during treatment with investigational or reference drug(26 weeks)
- Time from initiation of therapy with investigational or reference drug to reaching a stable platelet count(26 weeks)
- Number of clinically significant bleeding episodes during the treatment period, starting from the second week of therapy with investigational or reference drug(26 weeks)
- Change in ITP-specific bleeding assessment tool (ITP-BAT) scores at last visit from baseline at screening(26 weeks)
- Proportion of patients receiving approved ITP prophylactic drugs (glucocorticosteroids, azathioprine, danazol) in this study at the time of randomization(26 weeks)
研究者
研究点 (35)
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