Treatment of Chronic Hepatitis C Virus Infection With Direct Acting Antivirals in Kidney Transplant Recipients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- SVR12
研究概览
简要总结
Chronic hepatitis C virus (HCV) infection, an important cause of morbidity and mortality worldwide, is a significant problem in kidney transplant recipients (KTRs) given its high prevalence in patients undergoing hemodialysis. Interferon based regimens were cornerstone of treatment of HCV infection in the past; however, due to their low efficacy and high rates of adverse effects, they have been abandoned in the new era of direct acting antivirals (DAAs). Several studies demonstrated the efficacy and safety of DAAs, yet data regarding clinical practice of these agents in KTRs is still needed. Therefore, we conducted a study using our registry data to evaluate the efficacy and safety of DAAs in KTRs.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Being a kidney transplant recipient.
- •Having a detectable level of HCV RNA.
- •Having direct acting antivirals for 12 or 24 weeks.
排除标准
- •Withdrawing or not providing consent.
结局指标
主要结局
SVR12
时间窗: 6 months
Undetectable levels of HCV RNA for 12 weeks after the end of treatment with direct acting antivirals.
次要结局
- Stable Graft Function(6-12 months)
- Stable Serum Trough Levels of Immunosuppressive Agents(6 months)
研究者
Safak Mirioglu
Principal Investigator
Istanbul University