Efficacy and Safety of human apotransferrin in patients with ß-thalassemia - Apotransferrin in patients with ß-thalassemia

Sanquin Plasma Products BV0 个研究点目标入组 12 人开始时间: 2018年11月28日最近更新: 2022年4月19日

试验速览

暂无简介。

•1. Non-transfusion dependent ß-thalassemia intermedia, defined as patients with microcytic anemia in combination with an elevated HbA2 (>2.5%) and a hemoglobin of <6.2 mmol/L, or transfusion dependent ß-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 formula.
•Aspartate transaminase (AST)/alanine transaminase (ALT) =2.5 × ULN
•Alkaline phosphatase (AP) = 2.5 × ULN
•4. WHO performance 0, 1 or 2.
•5. Signed informed consent.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 12
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•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

发起方