JPRN-jRCT2080223462已完成1 期
An adaptive Phase I/II study to assess safety, efficacy, pharmacokinetics and pharmacodynamics of RO7112689 in healthy volunteers and patients with paroxysmal nocturnal hemoglobinuria (PNH)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 44
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
- >= 18age old 至 <= 75age old（—）
- 性别
- All
入选标准
- •Male or female patients between the age of 18 and 75 years
- •-A documented GPI-deficient PNH clone size of >= 10%
- •-PNH patients who have not been treated with any complement inhibitor or if previously treated stopped treatment due to lack of efficacy based on a single missense C5 heterozygous mutation (Part 2, 4)
- •-Patients receive regular infusions of eculizumab (Part 3, 4)
排除标准
- •-Known or suspected hereditary complement deficiency.
- •-History of meningococcal meningitis.
- •-Evidence of moderate to severe concurrent renal, liver, cardiac, pulmonary or gastrointestinal disease not related to PNH as determined by the Investigator.
- •-History of bone marrow transplantation.
研究者
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