跳至主要内容
临床试验/EUCTR2020-003879-18-PL
EUCTR2020-003879-18-PL进行中(未招募)1 期

Treatment of chronic hepatitis C in children aged 6 – 18 years using a pangenotypic direct-acting antiviral (sofosbuvir/velpatasvir)

Medical University of Warsaw0 个研究点目标入组 50 人开始时间: 2020年11月17日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
50

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

  • written, voluntary informed consent to participate in the study
  • diagnosis of chronic hepatitis C
  • age 6-18 years
  • Are the trial subjects under 18? yes
  • Number of subjects for this age range: 50
  • F.1.2 Adults (18-64 years) no
  • F.1.2.1 Number of subjects for this age range
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • refusal to consent to participate in the study
  • hypersensitivity to the active substance or excipients of the drug
  • no HCV RNA in blood serum in the presence of anti-HCV antibodies
  • pregnancy or breastfeeding
  • hepatitis B infection (active or past)
  • simultaneous intake of drugs that affect the interaction with active substances, including rosuvastatin or strong inhibitors of P-glycoprotein
  • active addiction to alcohol or intoxicants

研究者

发起方
Medical University of Warsaw

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