Impact of Ursodeoxycholic Acid, Silymarin, Antioxidants and Colchicine on Fibrosis Regression in HCV After Achieving Sustained Virological Response
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 400
- 主要终点
- Improvement in liver stiffness measurement by Fibroscan
研究概览
简要总结
with the introduction of Direct-acting antiviral agents in the management of HCV, the scope of inclusion criteria had been widened to include patients with compensated cirrhosis and even in special situations patients with decompensated liver disease; a chance that was not offered by the limited and strict inclusion criteria needed for treatment by pegylated interferon-based regimen. this made the number of patients with progressive liver fibrosis of cirrhosis had been inv=creased even after achieving SVR. the debate about the impact of SVR on halting fibrosis progression had risen; some studies postulated that patients benefit from an SVR through reduction of mortality, morbidity, and improved quality of life ; however, some patients may maintain their level of fibrosis or even progress to cirrhosis despite achieving SVR and the risk for HCC remains even after virologic eradication.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •chronic HCV
- •compensated liver disease (Child class A-B)
- •sustained virological response
- •liver stiffness by fibroscan >12.5 kPa denotes cirrhosis
排除标准
- •decompensated liver disease
- •chronic active HCV
- •hepatocellular carcinoma
- •other liver diseases as alcoholic liver disease, autoimmune liver disease, drug-induced liver disease
- •pregnancy
研究组 & 干预措施
study group
200 patients with compensated liver cirrhosis (F4) by fibroscan; Child Turcotte Pugh score A, after achieving sustained virological response will be treated by anti-fibrotic agents
干预措施: Ursodeoxycholic Acid (Drug)
study group
200 patients with compensated liver cirrhosis (F4) by fibroscan; Child Turcotte Pugh score A, after achieving sustained virological response will be treated by anti-fibrotic agents
干预措施: Antioxidants (Drug)
study group
200 patients with compensated liver cirrhosis (F4) by fibroscan; Child Turcotte Pugh score A, after achieving sustained virological response will be treated by anti-fibrotic agents
干预措施: Colchicine (Drug)
study group
200 patients with compensated liver cirrhosis (F4) by fibroscan; Child Turcotte Pugh score A, after achieving sustained virological response will be treated by anti-fibrotic agents
干预措施: FOLLOW UP (Other)
control group
200 patients with compensated liver cirrhosis (F4) by fibroscan; Child Turcotte Pugh score A, after achieving sustained virological response will be followed up without any intervention
干预措施: FOLLOW UP (Other)
study group
200 patients with compensated liver cirrhosis (F4) by fibroscan; Child Turcotte Pugh score A, after achieving sustained virological response will be treated by anti-fibrotic agents
干预措施: silymarin (Drug)
结局指标
主要结局
Improvement in liver stiffness measurement by Fibroscan
时间窗: 1 year
Liver stiffness assessment by Fibroscan every 6 months
Improved portal hypertension parameters
时间窗: 1 year
Assessment of portal vein diameter, splenic vein diameter, portal vein congestive index by ultrasound and Doppler every 6 months
Improved splenic stiffness measurement
时间窗: 1 year
assessment by ultrasound and fibroscan
次要结局
未报告次要终点
研究者
Amr Shaaban Hanafy
Assistant professor of medicine
Zagazig University