Usefulness of Transient Elastography Assessing Liver Fibrosis and Portal Hypertension in Patients With HCV Cirrhosis Treated With New All Oral Antiviral Drugs
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Liver stiffness change during treatment and at 6 months of follow-up in patients who achieve sustained virological response (SVR).
研究概览
简要总结
The purpose of this study is to evaluate the effects of sustained virological response in liver and spleen stiffness in patients with HCV compensated advanced chronic liver disease treated with new all oral antiviral drugs in order to determine factors implicated in stiffness change and its implications for long-term follow-up.
详细描述
Prospective cohort study including consecutive patients (with baseline liver stiffness measurement ≥10 kPa who meet the Baveno VI criteria for compensated advanced chronic liver disease) who initiate treatment with new all oral antiviral drugs following current recommendations in Spain.
In all these patients the following parameters will be assessed:
- Baseline liver and spleen stiffness and CAP measurements at the time of starting therapy and then, during treatment in week 4 and week 12 (end of treatment). After finishing therapy, these measurements will be repeated at 6 and 12 months of follow-up.
- Routine lab tests, including liver enzymes and viral load, will be performed at baseline, 4 and 12 weeks of therapy, and at 3 and 6 months after finishing therapy according to standard clinical practice.
- Liver ultrasound will be performed every 6 months as a routine procedure in patients wiht liver cirrhosis.
- Patients who were known to have esophageal varices prior to therapy will be assessed with an upper endoscopy 12 months after finishing therapy if they achieve SVR.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 90 years.
- •History of chronic hepatitis C infection.
- •Compensated advanced chronic liver disease (Baveno VI definition):
- •Baseline liver stiffness ≥15 kPa or,
- •Baseline liver stiffness 10-15 kPa and one of the following: platelet count <150x10e9/L, spleen size ≥13 cm, nodular liver or collateral circulation in abdominal ultrasound, HVPG >5 mmHg, upper gastrointestinal endoscopy showing gastroesophageal varices or previous liver biopsy showing bridging fibrosis or cirrhosis.
- •Indication to start antiviral treatment with new oral drugs.
- •Willingness to enter the study.
- •Sign the informed consent.
排除标准
- •Chronic liver disease due to other etiology than HCV.
- •Terminal illness.
- •Treatment with interferon.
- •Liver stiffness measurement < 10 kPa at baseline.
结局指标
主要结局
Liver stiffness change during treatment and at 6 months of follow-up in patients who achieve sustained virological response (SVR).
时间窗: 6 months
Spleen stiffness change during treatment and at 6 months of follow-up in patients who achieve SVR.
时间窗: 6 months
次要结局
- Overall survival (Composite outcome including survival free of all cause of death, liver transplantation, decompensation and/or increase in >1 point in Child Pugh score).(12 months)