NL-OMON55171已完成3 期
A Phase 3 Study of Danicopan (ALXN2040) as Add-on Therapy to a C5 Inhibitor (Eculizumab or Ravulizumab) in Patients with Paroxysmal Nocturnal Hemoglobinuria Who Have Clinically Evident Extravascular Hemolysis (EVH) - ALXN2040-PNH-301
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 5
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
- 18 至 99（—）
入选标准
- •* Diagnosis of PNH
- •* Clinically Evident EVH defined by:
- •- Anemia (Hgb *9.5 gram/deciliter) with absolute reticulocyte count * 120 x
- •10^9/liter.
- •- At least 1 packed red blood cell or whole blood transfusion within 6 months
- •prior to the start of the study.
- •* Receiving a C5 inhibitor for at least 6 months prior to Day 1
- •* Platelet count *30,000/microliters (*L)
- •* Absolute neutrophil counts *750/*L.
- •* Documentation of/or willingness to receive vaccinations and prophylactic
- •antibiotics as required.
排除标准
- •* History of a major organ transplant or hematopoietic stem cell
- •transplantation (HSCT).
- •* Known aplastic anemia or other bone marrow failure that requires HSCT or
- •other therapies including anti-thymocyte globulin and/or immunosuppressants.
- •* Known or suspected complement deficiency.
- •* Laboratory abnormalities at screening, including:
- •- Alanine aminotransferase >2 x ULN.
- •- Direct bilirubin >2 x ULN (unless due to EVH or documented Gilbert's Syndrome.
- •* Current evidence of biliary cholestasis.
- •* Estimated glomerular filtration rate <30 milliliters/minute/1.73 meter
- •squared and/or are on dialysis.
- •* Evidence of human immunodeficiency virus, hepatitis B, or active hepatitis C
- •infection at screening.
研究者
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