2025-523793-16-00招募中2 期
A Phase 2, Multicenter, Randomized, Placebo-controlled, Double-blind Study of the Efficacy and Safety of Vamifeport in Adult Subjects with HFE-related Hereditary Hemochromatosis (FERROCLEAR Study)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 58
- 主要终点
- Change from baseline in magnetic resonance imaging (MRI)-based liver iron concentration (LIC) ,
研究概览
简要总结
To assess the effect of vamifeport treatment on magnetic resonance imaging (MRI)-based liver iron concentration (LIC) in adult participants with homeostatic iron regulator gene-related hereditary hemochromatosis (HFE-HH).
研究设计
- 分配方式
- Randomized
- 主要目的
- Overall Study
- 盲法
- Double (Investigator, Subject, Analyst, Monitor, Carer)
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
- •Adult (≥ 18 years) and has provided written informed consent.
- •Confirmed diagnosis of HFE-HH in medical history.
- •Evidence of iron overload as shown by: • TSAT > 45% (confirmed at 2 visits, at least 14 days apart) at Screening; and • Serum ferritin ≥ 200 ng/mL and < 5000 ng/mL (confirmed at 2 visits, at least 14 days apart) at Screening; and • MRI-based LIC between 3 and 16 mg/g (53.7 and 286.5 mmol/kg) dry weight (dw) at Screening.
- •Body mass index between 18.5 and 32 kilograms per meter squared (kg/m^2).
排除标准
- •Clinically relevant laboratory abnormalities, 12-lead electrocardiogram (ECG) findings, or medical history.
研究组 & 干预措施
CSL624
Test
干预措施: CSL624 (Drug)
Capsule (placebo matching vamifeport)
Placebo
干预措施: Capsule (placebo matching vamifeport) (Drug)
结局指标
主要结局
Change from baseline in magnetic resonance imaging (MRI)-based liver iron concentration (LIC) ,
Change from baseline in magnetic resonance imaging (MRI)-based liver iron concentration (LIC) ,
次要结局
未报告次要终点
研究者
Study Director
Scientific
CSL Behring LLC
研究点 (58)
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