JPRN-jRCT2080224673已完成2 期
A Phase 2/3 Study of AMG531 in Patients with Aplastic Anemia Previously Untreated with Immunosuppressive Therapy
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 14
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1) Voluntary signed informed consent to participate in the study;
- •2) A diagnosis of AA confirmed by blood and bone-marrow examinations, etc.;
- •3) Considered to require new treatment with ATG and CsA provided that NSAA must be platelet or erythrocyte transfusion-dependent.
- •4) An Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 to 1at screening;
排除标准
- •1) Previously treated with ATG, CsA, or Alemtuzumab;
- •2) Diagnosed as having congenital AA (Fanconi anemia, congenital dyskeratosis, etc.);
- •3) Diagnosed as having AML or chronic myelomonocytic leukemia;
- •4) Concurrent thrombocytopenia of other etiologies (e.g., MDS, ITP, cirrhosis);
- •5) Concurrent active infection not adequately responding to appropriate therapy;
- •6) Concurrent clinically significant illness(es) items which are deemed by the Investigator to be likely to affect the study conduct and assessments.
- •7) Having active malignancies, or having a history of treatment of malignancies within 5 years prior to informed consent.
- •8) Concurrent PNH
- •9) Having Grade 2 or higher bone marrow reticulin based on Bone Marrow Pathology (2nd edition) ;
- •10) History of chromosome aberrations discovered in bone marrow cells.
- •11) Having blast cells > 2% in bone marrow;
- •12) Positive for anti-human immunodeficiency virus (HIV) antibody;
- •13) Receiving prophylactic or therapeutic treatment for hepatitis type B
- •14) Positive for hepatitis C virus (HCV) antibody, and HCV infection being confirmed
- •15) Planned hematopoietic stem cell transplantation during the study;
- •16) Systemic treatment with any of the following medication for the treatment of AA within 4 weeks before Day 1, however, excluding their use as premedication:
- •- Anabolic steroids
- •- Corticosteroids;
- •17) Pregnant or breastfeeding women, or women willing to become pregnant;
- •18) Other conditions unsuitable for participation in the study in the opinion of the Investigator.
研究者
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