NL-OMON55838已完成2 期
Efficacy and Safety of human apotransferrin in patients with β-thalassemia intermedia - Apotransferrin in patients with β-thalassemia
Sanquin Plasma Products0 个研究点目标入组 12 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
研究概览
简要总结
Trial ended prematurely
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Non-transfusion dependent β-thalassemia intermedia, defined as patients with
- •microcytic anaemia in combination with an elevated HbA2 (>2.5%) and a
- •haemoglobin of <6.2 mmol/L, or transfusion dependent β-thalassemia treated with
- •a regular transfusion schedule.
- •2. Age >=18 years.
- •3. Adequate renal and hepatic function tests as indicated by the following
- •laboratory values:
- •Serum creatinine <=1.0 mg/dl (<= 88.7 µmol/L); if serum creatinine >1.0 mg/dl
- •(>88.7 µmol/L), then the glomerular filtration rate (GFR) must be >60
- •ml/min/1.73 m2 as calculated by the Modification of Diet in Renal Disease
- •equation where the predicted GFR (ml/min/1.73 m2) = 186 x (Serum Creatinine in
- •mg/dl) -1.154 x (age in years) - 0.203 x (0.742 if patient is female) x (1.212
- •if patient is black)
- •NOTE: if serum creatinine is measured in µmol/L, recalculate it in mg/dl
- •according to the equation: 1 mg/dl = 88.7 µmol/L) and used above mentioned
- •Aspartate aminotransferase (ASAT)/ alanine aminotransferase (ALAT) <=2.5 × ULN
- •Alkaline phosphatase (AP) <= 2.5 × ULN
- •4. WHO performance 0, 1 or 2.
- •5. Signed informed consent.
排除标准
- •1. Known with allergic reactions against human plasma or plasma products.
- •2. Concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled
- •diabetes, infection, hypertension, pulmonary disease).
- •3. Cardiac dysfunction as defined by: myocardial infarction within the last 6
- •months of study entry, unstable angina, or unstable cardiac arrhythmias.
- •4. Pregnant or lactating females.
- •5. Known with IgA deficiency with anti-IgA antibodies
研究者
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