EUCTR2020-003675-18-DE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 with a DAT =1 positive for IgG ±C3, or a diagnosis of mixed AIHA that is DAT positive for both IgG and C3, with a presence of a cold antibody with a thermal amplitude =30ºC
- •3. Hemoglobin level =10.0 g/dL (pre-transfusion) in wAIHA-01 within 6 weeks of the Day 1 dosing day or during the Week -6 or rescreening visits
- •4. Evidence of classical complement pathway activation in wAIHA-01 within 6 weeks of the Day 1 dosing date or during the wAIHA-02 screening:
- •a. Serum complement component 4 (C4) level no greater than 1.5 times the lower limit of normal and/or
- •b. CH50 below the lower limit of normal (LLN)
- •5. 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
- •6. 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 unless associated with wAIHA
- •3. Platelet count < 30 x 109/L
- •4. History of isolated cold agglutinin disease
- •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. Signs and symptoms of, or a diagnosis consistent with, a chronic autoimmune disorder and/or an ANA titer =1:160
- •9. Known genetic deficiencies of the complement cascade system
研究者
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