Study of the Effects of a Sartan on Hepatic Fibrosis Progression in Chronic Viral Hepatitis C
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 166
- 试验地点
- 2
- 主要终点
- Assessment of liver fibrosis changes by measurement of area of porto-septal fibrosis (morphometry)at M24
研究概览
简要总结
The purpose of this study is to examine the efficacy of irbesartan on the progression of liver fibrosis in adult patients with chronic hepatitis C.
The expected total enrollment is 200 patients. Patients who meet the study criteria and accept to participate at this study will take by day one tablet of 150 mg of treatment (irbesartan or placebo) during two years. The assessment of efficacy will be make by evaluation of area of liver fibrosis and blood markers of liver fibrosis
详细描述
The results of several studies suggests than the AT1 receptor antagonists of angiotensin II have inhibitory effects on TGF-beta 1 production and can limit the progression of liver fibrosis.
Therefore, the angiotensin II could be another mediator of the synthesis of the extra-cellular matrix at the hepatic level, opening new perspectives with the antagonists of angiotensin II receptors drugs (ARA2/sartans).
This study is a randomized, double blind, multi-center, parallel assignment, and efficacy study.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age between 18 and 75 years
- •liver biopsy performed (less 18 month before inclusion), fibrosis score F2,F3 or F3+ in Metavir classification,
- •patients without antiviral therapy
- •contraindication to anti viral treatment
- •non responders or relapsers patients to past antiviral treatment
排除标准
- •hepatocellular carcinoma
- •alcool abuser
- •cirrhosis
- •anti-fibrotic treatment
- •pregnancy or breast feeding
研究组 & 干预措施
group verum
Drug: Irbesartan
干预措施: Irbesartan (Drug)
group placebo
干预措施: placebo (Drug)
结局指标
主要结局
Assessment of liver fibrosis changes by measurement of area of porto-septal fibrosis (morphometry)at M24
时间窗: at M24
次要结局
- Assessment of liver fibrosis changes at M24 by non-invasive tests ((blood test mainly and also elastometry)(at M24)