Sustained Viral Response Rate in 100 Subjects With Cirrhosis Due to Hepatitis C Treated With 12 Weeks of Sofosbuvir, Daclatasvir and Ribavirin
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The sustained viral response rate
研究概览
简要总结
The investigators will treat 100 patients with cirrhosis due to hepatitis C with sofosbuvir 400 mg daily, daclatasvir 60 mg daily and weight-based ribavirin (1000 mg/d if <75 kg, 1200 mg/d if >75 kg, divided in two daily doses) for 12 weeks and calculate the sustained viral response rate at 12 weeks.
详细描述
Cirrhosis due to Hepatitis C presents a rather difficult treatment problem as many cannot tolerate interferon, the previous standard of treatment. The new direct acting antivirals have provided these patients with a new hope. One such combination is sofosbuvir (SOF) 400 mg and daclatasvir (DCV) 60 mg given once daily with or without weight-based ribavirin (RBV) for 12 or 24 weeks. The current recommendation for cirrhotics is SOF/DCV/RBV for 24 weeks but that recommendation is based on the lack of data for shorter periods. In order to evaluate the response rate to the combination of SOF/DCV/RBV the investigators decided to treat 100 HCV cirrhotics with this combination for 12 weeks. Subjects include genotype 1 and 3 patients, the prevalent genotypes in Iran. Patients with Model for End stage Liver Disease (MELD) > 20 are excluded. The investigators will calculate the sustained viral response rate at 12 weeks (SVR12).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Positive qualitative HCV RNA test on two occasions at least 6 months apart
- •Cirrhosis proven by either of:
- •Liver biopsy,
- •Liver elasticity > 12 kilopascal (KPa),
- •Clinical certainty (ascites, splenomegaly, small liver, low albumin, low platelet)
排除标准
- •Renal failure (eGFR < 30 cc/min),
- •MELD score > 20,
- •Child's C (CTP score > 12),
- •Heart rate < 50/min,
- •Taking amiodarone
研究组 & 干预措施
Treatment
Subjects will receive sofosbuvir, daclatasvir and ribavirin
干预措施: Sofosbuvir (Drug)
Treatment
Subjects will receive sofosbuvir, daclatasvir and ribavirin
干预措施: Daclatasvir (Drug)
Treatment
Subjects will receive sofosbuvir, daclatasvir and ribavirin
干预措施: Ribavirin (Drug)
结局指标
主要结局
The sustained viral response rate
时间窗: week 24 (12 weeks after end of treatment)
Qualitative HCV RNA polymerase chain reaction (PCR)
次要结局
- Adverse drug events(week 2, 4, 8, 12, 24)
研究者
Reza Malekzadeh, MD
Professor of Gastroenterology and Hepatology
Tehran University of Medical Sciences