2024-515986-33-00招募中2 期
Dose escalating study to evaluate pharmacokinetics, efficacy and safety of apotransferrin in atransferrinemia patients
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 5
- 试验地点
- 3
- 主要终点
- Decrease of serum ferritin (to normal range)
研究概览
简要总结
To investigate the pharmacokinetics, efficacy and safety of apotransferrin replacement therapy
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomized
- 主要目的
- Long-term Follow-up
- 盲法
- None
入排标准
- 年龄范围
- 0 years 至 64 years（18-64 Years, 0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •Established diagnosis of atransferrinemia, defined as serum levels of transferrin below 40 mg/dL
- •Signed informed consent
排除标准
- •Known with allergic reactions against human plasma or plasma products
- •Having detectable anti-IgA antibodies
- •Fertile women unless they take valid contraceptive measures (ITA only)
结局指标
主要结局
Decrease of serum ferritin (to normal range)
Decrease of serum ferritin (to normal range)
Increase of hemoglobin (to normal range)
Increase of hemoglobin (to normal range)
Pharmacokinetics of transferrin
Pharmacokinetics of transferrin
次要结局
- Decrease of iron overload (liver, heart)
- Transferrin levels, transferrin saturation, and serum iron in relation to efficacy
- Undetectable NTBI/LPI levels
- Increase of hematocrit (to normal range)
- Increase of erythrocytes (to normal range)
研究者
Ilona Kleine Budde
Scientific
Prothya Biosolutions Netherlands B.V.
研究点 (3)
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