Regression of Liver Fibrosis Assessed by Transient Elastography After Daclatasvir and Asunaprevir Combined Treatment in Advanced Fibrotic/Cirrhotic Patients With Chronic Hepatitis C Genotype 1b Infection
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 103
- 试验地点
- 10
- 主要终点
- The change of liver fibrosis stage at 48 weeks assessed by transient elastography in patients treated with Daclatasvir and Asunaprevir
研究概览
简要总结
A study on regression of liver fibrosis assessed by transient elastography after Daclatasvir and Asunaprevir combined treatment in advanced fibrotic/cirrhotic patients with chronic hepatitis C genotype 1b Infection
详细描述
The measurement of liver stiffness by transient elastography (TE) has been shown to correlate with the hepatic fibrosis stage and to have considerable accuracy for the diagnosis of cirrhosis in patients with chronic hepatitis C. Previous studied reported that liver stiffness is significantly reduced in SVR patients with pegylated interferon (IFN) and ribavirin treatment. Once a patient achieve sustained virological response (SVR), and resultingly lower liver stiffness score than baseline value, it is believed that he will have a better long-term outcome due to the improvement of liver fibrosis.
Daclatasvir(DCV) and Asunaprevir(ASV) combined treatment showed a greater SVR rate in CHC compared to IFN based therapy. The investigators hypothesize that DCV and ASV combined treatment may achieve the improvement of liver stiffness measured by TE and a more favorable clinical outcomes in patients with advanced liver fibrosis. The investigators will also compare the change of fibrosis stage assessed by TE between this study subjects and those treated with other DAA agents during same observational period.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronically infected with Hepatitis C virus genotype 1b
- •HCV RNA ≥ 10^4 IU/mL (10,000 IU/mL)
- •Chronic Hepatitis C with advanced fibrosis or cirrhosis (defined as ≥F3, ≥8 kilopascals)
- •Treatment-naïve or those who previously failed to treatment with peg-interferon alfa and ribavirin
- •Women of childbearing potential (WOCBP) and men, who use effective methods of birth control
排除标准
- •Patients with baseline key NS5A RAVs (Y93 and/or L31)
- •Estimated GFR < 30mL/min without hemodialysis
- •Alanine aminotransferase (ALT) > 100 IU/L
- •Coinfection with other hepatitis virus or human immunodeficiency virus
- •A daily alcohol intake >30 g
- •Decompensated liver disease or hepatocellular carcinoma, liver or any other organ transplantation
研究组 & 干预措施
Daclatasvir plus Asunaprevir treatment
Among patients taking Daclatasvir and Asunaprevir combined treatment and having advanced liver fibrosis assessed by transient elastography
干预措施: Daclatasvir and Asunaprevir (Drug)
结局指标
主要结局
The change of liver fibrosis stage at 48 weeks assessed by transient elastography in patients treated with Daclatasvir and Asunaprevir
时间窗: baseline to 48weeks
To compare the change of liver fibrosis stage (defined as F3, ≥8; F4, ≥12) assessed by transient elastography between baseline and 48 weeks in advanced fibrotic/cirrhotic Chronic Hepatitis C patients who achieved sustained virological response with Daclatasvir and Asunaprevir combined treatment
次要结局
- Proportion of patients who maintained sustained virologic response at SVR24, SVR72, SVR120, SVR168, and SVR216.(baseline to 48weeks, 96weeks, 144weeks, 192weeks, 240weeks)
- The change of liver fibrosis stage assessed by transient elastography at 96weeks, 144weeks, 192weeks, 240weeks in patients treated with Daclatasvir and Asunaprevir(baseline to 96weeks, 144weeks, 192weeks, 240weeks)
- The change of AST to Platelet Ratio Index(baseline to 48weeks, 96weeks, 144weeks, 192weeks, 240weeks)
- The change of Fibrosis 4 (Fib-4) index(baseline to 48weeks, 96weeks, 144weeks, 192weeks, 240weeks)
- The change of Fibrometer score(baseline to 48weeks, 96weeks, 144weeks, 192weeks, 240weeks)
- Proportion of patients who were treated with Daclatasvir and Asunaprevir achieved SVR12 assessed by HCV RNA(baseline to 36 weeks)
- Comparison of the incidence of hepatocellular carcinoma or liver cirrhosis complications between Daclatasvir and Asunaprevir combined treatment versus other DAA treatment(baseline to 48weeks, 96weeks, 144weeks, 192weeks, 240weeks)
- Comparison of change of liver fibrosis stage assessed by transient elastography between Daclatasvir and Asunaprevir combined treatment versus other DAA treatment(baseline to 48weeks, 96weeks, 144weeks, 192weeks, 240weeks)
研究者
Sang Gyune Kim
Professor
Soonchunhyang University Hospital