Quality of Life in Patients With HCV Related Liver Cirrhosis Before and After Direct Acting Antiviral Drugs
研究概览
详细说明
Hepatitis C has been associated with substantial resource utilization as a result of its effect on the liver as well as other organ systems (the extrahepatic manifestations of HCV). It has been widely reported to have a profound negative impact on patient's health-related quality of life (HRQL).
The reduction of HRQL is probably also due to physical and psychiatric symptoms as a direct consequence of this chronic infection and its sequelae (such as cirrhosis). The chronic inflammation is believed to signal the brain and to give rise to neurovegetative symptoms (e.g. malaise and fatigue) and to amongst others depression and concentration difficulties. Possibly, also the brain itself is infected by HCV . The Egyptian government introduced Sofosbuvir as the first DAAs into Egypt through the government funded National Treatment Program. These agents are highly efficacious with significantly fewer side effects .
To date, there is only one study reported about how Egyptian HCV patients receiving the new DAAs perceive their HRQL. This study is first one to be done in Upper Egypt to assess health-related quality of life of HCV patients receiving direct acting antivirals (DAAs) therapy prior and at the end of therapy
研究类型
注册 (预期的)
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Patients with hepatitis C related liver cirrhosis (diagnosed clinically laboratory and by imaging).
- Age 18 years or older
- Eligible for starting DAAs therapy according to Egyptian National Guidelines will be enrolled.
- Follow up of those patients during and after DAAs therapy (clinically ,laboratory,imaging and with a questionnaire ) to determine HRQL.
Exclusion Criteria:
- Any patient with liver cirrhosis secondary to causes other than chronic HCV infection e. g. auto immune liver disease, PBC
- Coinfection with other viruses as HBV, HIV.
- Had significant psychiatric illnesses (diagnosed by psychiatrist)
学习计划
研究是如何设计的?
设计细节
- 观测模型:仅案例
- 时间观点:预期
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Quality of Life in patients with HCV related liver cirrhosis before and after Direct Acting Antiviral Drugs
大体时间:one year
|
evaluate the effects of DAAs on HRQL in patients with liver cirrhosis secondary to chronic HCV infection
|
one year
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (预期的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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