2024-519207-10-00招募中4 期
Ravulizumab dose optimization
Radboud universitair medisch centrum Stichting1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2025年2月17日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Percentage of change in LDH compared to baseline LDH between standard dosing and individualized dosing
研究概览
简要总结
The main objective is to describe the effectiveness of individualized dosing of ravulizumab compared to standard dosing of ravulizumab in adult PNH patients.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •The patient is eligible for treatment with ravulizumab in line with relevant Dutch guidelines or is already being treated with ravulizumab according to the label and Dutch guidelines.
- •Willing to provide written informed consent
- •16 years or older
排除标准
- •Patients with thrombosis during treatment with complement inhibitors in the medical history
- •Patients with other concomitant hematological diseases, with the exception for aplastic anemia/PNH
- •Unstable medical conditions (e.g. myocardial infarction, bleeding)
- •Pregnant or lactating patients
- •An LDH >1.5x ULN during the 8 weeks prior to screening for inclusion
- •Use of high dose corticosteroids(defined as >30mg prednisolone equivalent daily during the 8 weeks prior to the screening for inclusion)
结局指标
主要结局
Percentage of change in LDH compared to baseline LDH between standard dosing and individualized dosing
Percentage of change in LDH compared to baseline LDH between standard dosing and individualized dosing
Difference in percentage target attainment (Ravulizumab concentration >100 mg/L) between the standard dosing regimen and the individualized dosing regimen
Difference in percentage target attainment (Ravulizumab concentration >100 mg/L) between the standard dosing regimen and the individualized dosing regimen
次要结局
- The proportion of patients with breakthrough hemolysis, defined as at least 1 new or worsening symptom or sign of intravascular hemolysis (fatigue, hemoglobinuria, abdominal pain, shortness of breath [dyspnea], anemia [hemoglobin <10 g/dL], major adverse vascular event [including thrombosis], dysphagia, or erectile dysfunction) in the presence of elevated LDH ≥2× the ULN after prior reduction of LDH to <1.5× the ULN on treatment
- Quality of life assessed with the FACIT-Fatigue Scale and patient preference
- Differences between number of transfusions between both dosing strategies
- Differences in cumulative ravulizumab dose over 52 weeks, number of infusions and appointments with the physician as surrogate marker for treatment costs.
研究者
Saskia Langemeijer
Scientific
Radboud universitair medisch centrum Stichting
研究点 (1)
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