跳至主要内容
临床试验/NCT03480269
NCT03480269Unknown不适用

Very Rapid and Rapid Virological Response as Predictors of Response to Sofosbuvir / Daclatasvir Treatment of HCV Related Liver Disease

Assiut University0 个研究点目标入组 100 人开始时间: 2018年8月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
主要终点
Rapid virological response (undetected HCV RNA after 4 weeks from the begin of antiviral treatment)

研究概览

简要总结

assessment of very rapid virological response and rapid virological response as predictors of response to sofosbuvir and daclatasvir in treatment of cirrhotic and non-cirrhotic patients with HCV, eligible to treatment.

详细描述

Chronic hepatitis C infection (CHC) is a global health problem, with an estimated 120 to 130 million chronic hepatitis C virus (HCV) carriers worldwide Therefore, early recognition and effective management of the disease can modify its natural history

. There is a growing body of evidence that suggests that treatment will help reduce liver inflammation, may reverse liver damage (scarring),slow down disease progression and improve symptoms and quality of life. All of these factors are important reasons to seek HCV medical treatment Identifying host-viral factors that predict the likelihood of SVR prior to initiating therapy would be a very useful clinical tool that could help reduce costs and avoid unnecessary exposure to therapy with significant side effects Little is known about predictors of failure to achieve SVR with DAAs. Although numerous clinical parameters predicted poor response to pegylated IFN treatment , none of them have been shown to be associated with virological relapse after DAA based therapy

Treatment response terms:

The ultra rapid virological response (uRVR) is a new endpoint that we defined as an undetectable serum HCV RNA at the end of 1st week of therapy.

The very rapid virologic response( vRVR )defined as undetectable serum HCV RNA level at week 2.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Anti HCV positive patients either chronic HCV or liver cirrhosis.
  • Detectable HCV RNA by quantitative PCR prior to treatment.
  • Naïve patients (not received any HCV treatment regimen before)

排除标准

  • Patients with hepatocellular carcinoma( HCC)
  • Patients with combined HBV and HCV

结局指标

主要结局

Rapid virological response (undetected HCV RNA after 4 weeks from the begin of antiviral treatment)

时间窗: April 2018 to April 2019

To assess rapid virological response as a predictor of response to sofosbuvir and daclatasvir in treatment of cirrhotic and non-cirrhotic patients with HCV. It measure the relation between rapid virological response and achievment of sustained virological response (Undetected HCV RNA 12-24 weeks after the end of treatment )

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sara Mohammed Mahrous Sayed

Doctor

Assiut University

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