跳至主要内容
临床试验/KCT0003715
KCT0003715招募中未知

Secondary hemochromotosis adJustment in patients with transfusion-dependent Anemia by early administration of low dose deferasirox

Gachon University Gil Medical Center0 个研究点目标入组 103 人开始时间: 待定最近更新:
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

研究者

相似试验

已完成
不适用
Evaluation of hemostatic changes in patients with severe thermal injury using thrombin generation and thrombelastometry.T20-T32I80.9Burns and corrosionsPhlebitis and thrombophlebitis of unspecified site
DRKS00004369Medizinische Universität Wien20
进行中(未招募)
不适用
Treatment of the haematological relapse in patients suffering from acute myeloid leukaemia or myelodysplastic syndrome with 5-Azacytidin (Vidaza®) after hematopoietic stem cell transplantation RELAZA - RELAZA
EUCTR2006-001040-31-DEniversity of Technology Dresden
已完成
不适用
Treatment of neonatal hemochromatosis with high-dose intravenous immunoglobulin during pregnancyneonatal haemochromatosis
JPRN-UMIN000020469Department of Pediatrics, School of Medicine, Institute of Medical Pharmaceutical and Health Sciences, Kanazawa University2
进行中(未招募)
1 期
PPI in secondary hemochromatosis.Iron overload (secondary hemochromatosis) in non-transfusion dependent forms of hereditary anemias. Iron overload and hereditary anemia are a growing, underestimated emerging health care problem.MedDRA version: 20.0Level: LLTClassification code 10002272Term: AnemiaSystem Organ Class: 100000004851MedDRA version: 20.0Level: LLTClassification code 10057875Term: Secondary haemochromatosisSystem Organ Class: 100000004861MedDRA version: 20.0Level: HLTClassification code 10022979Term: Iron excessSystem Organ Class: 100000004861MedDRA version: 20.0Level: LLTClassification code 10055610Term: HemoglobinopathySystem Organ Class: 100000004850MedDRA version: 20.0Level: LLTClassification code 10074356Term: Non-transfusion dependent thalassemiaSystem Organ Class: 100000004850
EUCTR2017-003777-34-NLMC Utrecht40
已完成
不适用
PPI in secondary hemochromatosis.
NL-OMON25811niversity Medical Center Utrecht30