KCT0003715招募中未知
Secondary hemochromotosis adJustment in patients with transfusion-dependent Anemia by early administration of low dose deferasirox
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 103
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 18(Year) 至 o Limit(—)
- 性别
- All
入选标准
- •Red blood cell transfusion-dependent anemia with low accumulation of iron
- •- 50ng/ mL <serum ferritin=500ng/mL
- •- Accumulated red blood cell transfusions=10 units
- •- Red blood cell transfusion-dependent anemia (receiving more than 2 units of red blood cell transfusion within four months)
- •- The causes of anemia include one of the followings:
- •Aplastic anemia
- •(idiopathic cytopenia of undetermined significance)
- •(clonal cytopenia of undetermined significance)
- •Idiopathic myelofibrosis
- •- Blood disorders requiring long-term red blood cell transfusions
- •- Aged 18 years and over
- •- Obtaining the informed consent with signature and dates
- •- Healthy liver and kidneys (AST, ALT, bilirubin, and creatinine levels below the normal upper limit by 2.5 times).
- •- Those who did not achieve CR after the primary induction chemotherapy for the newly diagnosed, therapy naïve AML (if re-induction therapy is performed according to the preliminary plan for primary induction chemotherapy, it is considered that the first-line therapy is performed only.)
排除标准
- •Iron-deficiency anemia (serum ferritin<50ng/mL)
- •Acute leukemia
- •Medication or treatment-induced anemia
- •Myelodysplastic syndrome
- •IPSS intermediate-2 or high
- •Platelet count <50x109/L
- •Progressive malignant tumor
- •Patients to receive stem cell transplantation within six months
- •Active infections
- •Patients difficult to comply with treatment due to psychiatric or cognitive problems
- •Hypersensitive to the medicine’s main ingredients or other components
- •Creatinine clearance <60mL/min or serum creatinine level doubled from the normal upper limit based on age
- •History of treatment with deferasirox
- •Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
- •pregnancy women
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