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临床试验/EUCTR2010-018491-24-NL
EUCTR2010-018491-24-NL进行中(未招募)不适用

Effect of aminobisphosphonates and statins on circulating Vy9Vd2-T cells

Vrije Universiteit Medical Center0 个研究点开始时间: 2010年3月17日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
发起方

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • -patients with an indication for intravenous treatment with an aminobisphosphonate because of bone metastases of a malignant tumor.
  • -WHO 0, 1, 2 performance score
  • 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
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range

排除标准

  • -WHO 3, 4 performance score
  • -prior or current use of aminobisphosphonates
  • -immunosuppressive medication (NSAID allowed)
  • -chemotherapy and/or radiotherapy in 4 weeks prior to start of aminobisphosphonate administration
  • -renal insufficiency (creatinin clearance < 30 ml/min)
  • -liver enzyme abnormalities: -bilirubin > 1.5 times ULN (upper limit of normal);
  • -ASAT or ALAT > 2.5 times ULN (in absence of livermetastases);
  • -ASAT or ALAT > 5 times ULN (in presence of livermetastases)
  • -concomitant use of strong inhibitors of CYP3A4, such as itraconazol, ketoconazol, erytromycin, claritromycin, hiv-protease inhibitors or grapefruit juice is contra-indicated.

研究者

发起方
Vrije Universiteit Medical Center

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