NCT04256148撤回2 期
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Study of ALXN1830 in Patients With Warm Autoimmune Hemolytic Anemia
适应症
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Percentage Of Participants With ≥ 2 Grams (g)/Deciliter (dL) Increase In Hemoglobin (Hgb) From Baseline
研究概览
简要总结
The main objective of the study is to evaluate the safety and efficacy of ALXN1830 compared to placebo in adult participants with warm autoimmune hemolytic anemia (WAIHA).
详细描述
This study will consist of a 4-week Screening period, 13-week Primary Treatment period, and optional Extended Treatment period (up to 2 years).
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
Double-blind
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary or secondary WAIHA, diagnosed at least 6 weeks prior to Screening
- •Failed or not tolerated at least 1 prior WAIHA treatment regimen, for example, corticosteroids, rituximab, azathioprine, cyclophosphamide, cyclosporine, mycophenolate mofetil, danazol, or vincristine
- •Hemoglobin < 10 g/dL and ≥ 6 g/dL
- •Positive direct antiglobulin test (Coombs) (IgG positive, complement C3 [C3] positive or negative)
- •Evidence of active hemolysis including any of the following: a) Lactate dehydrogenase (LDH) > upper limit of normal (ULN), b) Haptoglobin < lower limit of normal (LLN), c) Indirect bilirubin > ULN
- •Total IgG > 500 mg/dL
排除标准
- •Human immunodeficiency virus (HIV) infection (positive HIV-1 or HIV-2 antibody test)
- •Positive hepatitis B surface antigen (HBsAg) or hepatitis C antibody test
结局指标
主要结局
Percentage Of Participants With ≥ 2 Grams (g)/Deciliter (dL) Increase In Hemoglobin (Hgb) From Baseline
时间窗: Baseline (Day 1) through Day 92
次要结局
- Total Number Of Units Of Packed Red Blood Cells (pRBCs) Transfused(Day 15 through Day 92)
- Mean Change From Baseline To Day 92 In Quality Of Life, Assessed Via Functional Assessment Of Cancer Therapy Anemia (FACT-AN) Questionnaire(Baseline, Day 92)
- Mean Change From Baseline To Day 92 In Quality Of Life, Assessed Via EuroQoL 5 Dimension 5 Level (EQ-5D-5L) Questionnaire(Baseline, Day 92)
- Number Of Weekly Hgb Measurements With Change From Baseline ≥ 2 g/dL(Day 1 through Day 92)
- Number Of Participants Needing New WAIHA Rescue Medication Or Increase In Dose Of WAIHA Medication(Day 15 through Day 92)
研究者
研究点 (2)
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