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临床试验/ACTRN12618001939280
ACTRN12618001939280终止4 期

Sofosbuvir/Velpatasvir and Mental Health Impact in people with Lived Experience and Hepatitis C infection - SMILE-C Trial

The University of Adelaide0 个研究点目标入组 18 人开始时间: 2018年11月29日最近更新:
适应症

试验速览

阶段
4 期
状态
终止
入组人数
18

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomised controlled trial
主要目的
Treatment
盲法
Blinded (masking used)

入排标准

年龄范围
18 Years 至 o limit(—)
性别
All

入选标准

  • 18 years of age or above
  • HCV RNA positive detected by PCR (PCR to be repeated if older than 12 months)
  • Established and stably treated schizophrenia, schizoaffective disorder or bipolar disorder, i.e. stably treated defined as no expected significant changes to the participant’s mental health treatment within six months after the baseline visit
  • HCV treatment naïve or experienced (defined as prior exposure to interferon-based therapy)
  • A comprehensive understanding of verbal and written English
  • Capacity to provide informed consent

排除标准

  • Unstable mental health status at time of enrolment requiring acute intervention (e.g. psychosis, mania, suicidal depression)
  • Prior failure of a NS5A inhibitor containing antiviral regimen
  • Decompensated liver disease
  • Need for addition of ribavirin to the Sofosbuvir/Velpatasvir
  • eGFR<30 mL/min1.73m2
  • Pregnant and breastfeeding women. Birth control whilst taking Sofosbuvir/Velpatasvir will be discussed
  • HIV coinfection
  • Taking any drug with known reported significant interactions with Sofosbuvir/Velpatasvir https://www.hep-druginteractions.org/checker

研究者

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