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临床试验/NCT03241823
NCT03241823Unknown不适用

Assessment of Hepatic Fibrosis, Hemodynamics, and Disease Severity of Patients With Hepatitis C Virus Related Liver Cirrhosis After Sustained Response to Direct Acting Anti Viral Drugs.

Assiut University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2017年12月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
Changes in liver fibrosis

研究概览

简要总结

Hepatitis C Virus (HCV) infection is a major global health challenge; it is estimated that more than 80 million people are chronically infected worldwide, with 3-4 million new infections and 350,000 deaths occurring each year because of HCV-related complications .

详细描述

In 2015, a national Egyptian health issue survey was conducted to describe the prevalence of hepatitis C virus infection. The prevalence of hepatitis C virus antibody was found to be 10.0% and that of Hepatitis C virus Ribonucleic acid (HCV RNA ) to be 7.0% in the age group between 15-59 years. While In children, 1-14 years old, the prevalence of Hepatitis C virus (HCV) antibody and Hepatitis C virus Ribonucleic acid (HCV RNA) were 0.4% and 0.2% respectively.

The primary goal of HCV therapy is to cure the infection, i.e. to achieve a sustained virological response (SVR) defined as undetectable Hepatitis C virus Ribonucleic acid (HCV RNA )12 weeks or 24 weeks after treatment completion. The infection is cured in more than 99% of patients who achieve asustained virological response (SVR). Asustained virological response (SVR) is generally associated with normalization of liver enzymes and improvement or disappearance of liver necroinflammation and fibrosis in patients without cirrhosis. Patients with severe liver disease remain at risk of life-threatening complications; however hepatic fibrosis may regress and the risk of complications such as hepatic failure and portal hypertension is reduced .

Previous data suggest that the risk of Hepatocellular carcinoma and all-cause mortality is significantly reduced, but not eliminated, in cirrhotic patients who clear Hepatitis C Virus compared to untreated patients and non-sustained virological responders . Hepatitis C Virus is also associated with a number of extrahepatic manifestations and effective viral suppression induces reversal of most of them .

Studies in those with hepatitis C-related decompensated cirrhosis have demonstrated that sustained virological response can indeed be achieved in the majority of these individuals, and short-term follow-up from these studies has shown that Sustained virological response is often accompanied by improvement in measures of decompensation including Model for End-Stage Liver Disease (MELD) score and Child-Turcotte-Pugh (CPT) score. Moreover, because hepatitis C recurrence after Orthotopic liver transplantation is associated with worse outcomes, achieving Sustained virological response before transplant in a decompensated population with chronic hepatitis C will likely allow these patients to achieve long-term outcomes not different from non-Hepatitis C virus-infected populations .

In the SOLAR-1 and SOLAR-2 studies, those with decompensated cirrhosis with genotypes 1 and 4 were randomized to receive sofosbuvir/ledipasvir with low-dose ribavirin for 12 or 24 weeks . No difference was seen in Sustained virological response in the 12- or 24-week arms, and the therapy was well tolerated. Moreover, these studies both reported improvement in Model for End-Stage Liver Disease (MELD) score and Child-Turcotte-Pugh (CPT) scores 4 weeks after therapy had been stopped with longer-term follow-up results expected.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age: ≥ 18 years.
  • Disease status: patients with hepatitis C Virus related liver cirrhosis child A& B (scores 5-9).
  • Previous treatment: treatment naïve and treatment experienced.
  • HCV RNA: Negative at any point between 12-24 weeks post treatment to confirm successful eradication of the virus.
  • Negative HBsAg and HIV antibody.
  • Normal kidney function test

排除标准

  • Child C liver cirrhosis (Child score ≥ 10).
  • HCV coinfection with HBV or HIV.
  • Patients with high risk of infection (I.V drug users, patients with blood disease requiring blood transfusion).

结局指标

主要结局

Changes in liver fibrosis

时间窗: 1 year.

Using non-invasive measures "Fibroscan"

次要结局

  • Changes occurring in liver haemodynamics(1 year.)
  • Changes in severity of liver disease(1 year)

研究者

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

Ibrahim Taha

principal investigator

Assiut University

研究点 (1)

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