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
干预措施
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
- 18
- 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.
研究组 & 干预措施
Nplate
Active Comparator
Control group (80 patients) - multiple weekly subcutaneous injections of Nplate, doses are calculated individually.
干预措施: Nplate (Biological)
GNR-069
Experimental
Main group (80 patients) - multiple weekly subcutaneous injections of GNR-069, doses are calculated individually.
干预措施: GNR-069 (Biological)
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
- Change in ITP-specific bleeding assessment tool (ITP-BAT) scores at last visit from baseline at screening(26 weeks)
- 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)
- 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 (18)
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