NCT04095936已完成2 期
A Phase 2/3 Study of AMG531 Combined With Ciclosporin A in Patients With Aplastic Anemia Previously Untreated With Immunosuppressive Therapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Rate of achievement of complete response (CR) or partial response (PR)
研究概览
简要总结
To evaluate the hematological responses based on the response assessment criteria defined in this study (the 531-004 response assessment criteria) when AMG531 is subcutaneously (SC)-administered with ciclosporin A (CsA) therapy for 6 months in patients with aplastic anemia (AA) who were previously untreated with immunosuppressive therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntary signed informed consent to participate in the study;
- •A diagnosis of AA confirmed by blood and bone-marrow examinations, etc.;
- •Considered to require new treatment with immunosuppressive therapy provided that NSAA must be platelet or erythrocyte transfusion-dependent.
- •An Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 to 1at screening;
排除标准
- •Previously treated with Anti-human thymocyte immunoglobulin (ATG), CsA, or Alemtuzumab;
- •Diagnosed as having congenital AA (Fanconi anemia, congenital dyskeratosis, etc.);
- •Diagnosed as having acute myelocytic leukemia (AML) or chronic myelomonocytic leukemia;
- •Concurrent thrombocytopenia of other etiologies (e.g., myelodysplastic syndrome (MDS), idiopathic thrombocytopenic purpura (ITP), cirrhosis);
- •Concurrent active infection not adequately responding to appropriate therapy;
- •Concurrent clinically significant illness(es) items which are deemed by the Investigator to be likely to affect the study conduct and assessments.
- •Having active malignancies, or having a history of treatment of malignancies within 5 years prior to informed consent.
- •Concurrent paroxysmal nocturnal hemoglobinuria (PNH)
- •Having Grade 2 or higher bone marrow reticulin based on Bone Marrow Pathology (2nd edition) ;
- •History of chromosome aberrations discovered in bone marrow cells.
- •Having blast cells > 2% in bone marrow;
- •Positive for anti-human immunodeficiency virus (HIV) antibody;
- •Receiving prophylactic or therapeutic treatment for hepatitis type B
- •Having hepatitis C virus (HCV) infection confirmed by HCV-RNA or other tests at screening.
- •Planned hematopoietic stem cell transplantation during the study;
- •Systemic treatment with any of the following medication for the treatment of AA within 4 weeks before Day 1:
- •Anabolic steroids
- •Corticosteroids;
- •Pregnant or breastfeeding women, or women willing to become pregnant;
- •Other conditions unsuitable for participation in the study in the opinion of the Investigator.
研究组 & 干预措施
AMG531
Experimental
干预措施: Romiplostim (Drug)
结局指标
主要结局
Rate of achievement of complete response (CR) or partial response (PR)
时间窗: 27 weeks post-dose
次要结局
- Change from baseline in platelet count (/µL)(Each time point evaluated weekly until Week 27)
- The time to CR or PR(Each time point evaluated weekly until Week 27)
- Change from baseline in neutrophil count (/µL)(Each time point evaluated weekly until Week 27)
- Rate of achievement of CR or PR(14 weeks)
- Reduction or independence of platelet and/or erythrocyte transfusion(Week 27)
- Change from baseline in hemoglobin (Hb) concentration (g/dL)(Each time point evaluated weekly until Week 27)
- Change from baseline in reticulocyte count (/µL)(Each time point evaluated weekly until Week 27)
- Rate of achievement of CR(Weeks 14 and 27)
研究者
研究点 (1)
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