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临床试验/KCT0004846
KCT0004846终止未知

Efficacy of antiplatelet therapy in reducing risk of recurrence for patients with hepatocellular carcinoma after curative hepatic resection or ablation: a randomized, double-blind, placebo-controlled, multi-center clinical trial

Seoul National University Hospital0 个研究点目标入组 288 人开始时间: 待定最近更新:
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适应症

试验速览

阶段
未知
状态
终止
入组人数
288
研究概览入排标准研究者记录与标识符相似试验

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
19(Year) 至 85(Year)（—）
性别
All

入选标准

  • •1) Patients who have been diagnosed with hepatocellular carcinoma and who have undergone surgical resection or radiofrequency ablation (RFA) as initial treatment within 3 months of the visit date.
  • •2) Patients who were confirmed as having no residual cancer on CT or MRI after surgical resection or radiofrequency ablation (RFA)
  • •3) Patients who voluntarily consent to participate in this study, and written consent by subject or legal representative

排除标准

  • •Any of the following subjects should be excluded from this clinical trial.
  • •1) Patients with chronic hepatitis C who have HCV RNA detected by HCV RNA PCR
  • •2) Patients who are receiving antiviral medication for chronic hepatitis B who are not suitable for changing to tefovir tablet according to the investigator's judgment'
  • •2-1) Decreased renal function: at least one of basal glomerular filtration rate <60 mL / min, proteinuria, albuminuria (urine albumin: creatinine> 30 mg / g) or hypophosphatemia (<2.5 mg / dL)
  • •2-2) Bone mineral density decrease: If you have osteopenia or osteoporosis, or if you need to use steroid drugs in the long term
  • •3) Patients who consume excessive alcohol (male, =210g / day; female, =140g / day)
  • •4) Patients who have received antiplatelet drugs containing aspirin (including general medicine) for at least 1 month within 5 years before screening
  • •5) Patients who need to simultaneously administer a high risk of bleeding (non-steroidal anti-inflammatory drugs or anticoagulants)
  • •6) Patients with risk of bleeding from esophageal varices or gastric varices during screening (high risk varicose veins: F2, F3 grade or with red color sign)
  • •7) Patients with decompensated liver cirrhosis (Child-Pugh class B or C)
  • •8) Patients who have hypersensitivity to tefovir or other ingredients in tefovir
  • •9) Patients with hypersensitivity to aspirin or salicylic acid
  • •10) Genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
  • •11) Patients with peptic ulcer, except ulcer scars
  • •12) Aspirin asthma (induced asthma attacks by nonsteroidal anti-inflammatory drugs) or a person with a history of it
  • •13) Hemophilia patients
  • •14) Patients with severe renal impairment (GFR <60 mL / min / 1.73m2, estimated by the Cockcroft-Gault formula)
  • •15) Patients with severe heart failure
  • •16) Patients with a tendency to bleed (Platelet count <50,000 / mm3)
  • •17) Patients co-administered at least 15 milligrams (15 mg / week) of methotrexate for 7 days
  • •18) Women who are pregnant, lactating or planning
  • •19) Patients in other clinical trials within 30 days prior to screening
  • •20) Patients who have failed to complete this study or have any medical condition that may interfere with the efficacy or safety evaluation of the investigational drug.

研究者

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