EUCTR2020-003675-18-BG进行中（未招募）1 期
A Phase 2, Open-Label, Repeat Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Proof-of-Concept of Intravenous ANX005 in Subjects with Warm Autoimmune Hemolytic Anemia
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Subjects must meet ALL the following criteria to be eligible to participate in the study:
- •1. Male or female =18 years of age on the day of signing informed consent
- •2. Diagnosis of wAIHA at least 3 months prior to screening
- •3. Hemoglobin level =10.0 g/dL (pre-transfusion) at screening with no alternative explanation for anemia apart from wAIHA
- •4. Positive DAT =1+ for C3d and IgG within 6 months prior to dosing
- •5. Evidence of classical complement pathway activation by at least one of the following within 6 months prior to dosing:
- •a. Serum complement component 4 (C4) below the lower limit of normal
- •b. CH50 below the lower limit of normal (LLN)
- •c. Complement component deposition on the cell surface assessed by flow cytometry
- •6. Evidence of active hemolysis based on at least one of the following:
- •a. LDH above the upper limit of normal (ULN)
- •b. Indirect bilirubin above the ULN
- •c. Haptoglobin below the LLN
- •7. Patients must have been previously vaccinated for encapsulated bacteria within 5 years prior to screening or be willing to receive prophylaxis against infections with encapsulated bacteria via vaccination and/or the use of prophylactic antibiotics in accordance with local standards of practice and/or guidelines.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2
排除标准
- •Subjects must not meet any of the following criteria:
- •1. Active lymphoma, lymphoproliferative disorder, or other malignancy requiring therapy and/or not clinically stable or in remission for at least 3 months prior to screening
- •2. Elevated aspartate aminotransferase or alanine aminotransferase levels > 2.5 times the upper limit of normal at screening
- •3. Platelet count < 30 x 10^9/L at screening
- •4. History of cold agglutinin disease or IgM cold agglutinin titer > 1:64
- •5. History of solid organ, bone marrow, or stem cell transplantation
- •6. History of splenectomy within the 3 months prior to screening
- •7. Received rituximab or other B cell depleting monoclonal antibody (eg. daratumumab) <90 days prior to screening
- •8. History of a systemic autoimmune disorder (eg. lupus) or primary immunodeficiency disorder (eg. common variable immune deficiency)
- •9. Known genetic deficiencies of the complement cascade system
研究者
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