To Evaluate the Safety and Efficacy of Sofosbuvir and Ribavirin in Patients With HCV (Genotype 3) Related Decompensated Cirrhosis" - A Randomized Open- Label Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- The Primary efficacy end point is SVR 24 defined as HCV RNA <LLOQ (lower limit of quantification)
研究概览
简要总结
In this prospective randomized trial, A Minimum of 300 consecutive patients of decompensated HCV (Hepatitis C Virus) related cirrhosis, presenting to the Institute of Liver and Biliary Sciences hospital will be included and those patients meeting the entry criteria received treatment with 400 mg of Sofosbuvir, administered orally once daily, and Ribavirin administered orally twice daily, with doses determined according to body weight(600 mg daily in patients with a body weight of ≤60 kg,800 mg daily in patients weighing >60 and ≤80 kg, and1000 mg daily in patients with a body weight of >80 kg). Based on the treatment duration, patients would be randomized in either of the 3 treatment groups -
- Group 1 - Sofosbuvir + Ribavirin x 24 weeks
- Group 2 - Sofosbuvir + Ribavirin x 36 weeks
- Group 3 - Sofosbuvir + Ribavirin x 48 weeks
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or Female ≥ 18 yrs
- •Baseline HCV RNA > 1000 IU/ml
- •Cirrhosis with current or prior decompensation
- •HCV (Hepatitis C Infection) Genotype 3
- •Treatment naïve or treatment experienced
排除标准
- •HIV or HBV (Hepatitis B Virus) co-infection
- •Recent Variceal bleed
- •Pregnancy
- •Haemolytic anaemia
- •Platelet counts <20,000/ml
- •Advanced HCC (Hepatocellular Carcinoma)
- •Renal dysfunction, GFR (glomerular filtration rate) < 30 ml/min
- •Haemoglobin < 10 g/dl
- •MELD (Model for End Stage Liver Disease) >25, CTP (Child-Turcotte-Pugh score) >12
- •Post organ transplant
研究组 & 干预措施
Sofosbuvir + Ribavirin 1
Sofosbuvir + Ribavirin x 24 weeks
干预措施: Sofosbuvir + Ribavirin 1 (Drug)
Sofosbuvir + Ribavirin 2
Sofosbuvir + Ribavirin x 36 weeks
干预措施: Sofosbuvir + Ribavirin 2 (Drug)
Sofosbuvir + Ribavirin 3
Sofosbuvir + Ribavirin x 48 weeks
干预措施: Sofosbuvir + Ribavirin 3 (Drug)
结局指标
主要结局
The Primary efficacy end point is SVR 24 defined as HCV RNA <LLOQ (lower limit of quantification)
时间窗: 48 weeks
次要结局
- Mortality at 6 months post therapy in all the 3 groups.(48 weeks)
- Reduction in HVPG >20% to baseline after 1 year in all the 3 groups.(48 weeks)
- SVR 12 defined as HCV RNA <LLOQ (lower limit of quantification)(36 weeks)
- Improvement in the liver function as determined by CTP (Child-Turcotte-Pugh score), MELD (Model for End Stage liver Disease)more than 2 points at 6 months and 1 year.(48 weeks)
- SVR 4 defined as HCV RNA <LLOQ (lower limit of quantification)(24 weeks)
- The secondary endpoint is any AE (Adverse Event) leading to permanent discontinuation of study drugs.(3 years)
- Number of new cases of Hepatocellular Carcinoma at end of therapy and at 6 months post therapy in all the 3 groups.(48 weeks)