To Evaluate the Safety and Efficacy of Sofosbuvir and Ribavirin in Patients With HCV (Genotype 3) Related Decompensated Cirrhosis
To Evaluate the Safety and Efficacy of Sofosbuvir and Ribavirin in Patients With HCV (Genotype 3) Related Decompensated Cirrhosis" - A Randomized Open- Label Study
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
研究概览
地位
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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-
Delhi
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New Delhi、Delhi、印度、110070
- Institute of liver and Biliary Sciences
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
有源比较器:Sofosbuvir + Ribavirin 1
Sofosbuvir + Ribavirin x 24 weeks
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实验性的:Sofosbuvir + Ribavirin 2
Sofosbuvir + Ribavirin x 36 weeks
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实验性的:Sofosbuvir + Ribavirin 3
Sofosbuvir + Ribavirin x 48 weeks
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
The Primary efficacy end point is SVR 24 defined as HCV RNA <LLOQ (lower limit of quantification)
大体时间:48 weeks
|
48 weeks
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次要结果测量
结果测量 |
大体时间 |
---|---|
The secondary endpoint is any AE (Adverse Event) leading to permanent discontinuation of study drugs.
大体时间:3 years
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3 years
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Mortality at 6 months post therapy in all the 3 groups.
大体时间:48 weeks
|
48 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.
大体时间:48 weeks
|
48 weeks
|
Number of new cases of Hepatocellular Carcinoma at end of therapy and at 6 months post therapy in all the 3 groups.
大体时间:48 weeks
|
48 weeks
|
Reduction in HVPG >20% to baseline after 1 year in all the 3 groups.
大体时间:48 weeks
|
48 weeks
|
SVR 4 defined as HCV RNA <LLOQ (lower limit of quantification)
大体时间:24 weeks
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24 weeks
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SVR 12 defined as HCV RNA <LLOQ (lower limit of quantification)
大体时间:36 weeks
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36 weeks
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合作者和调查者
调查人员
- 首席研究员:Ankur Jindal, DM、Institute of liver and Biliary Sciences
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
HCV Related Cirrhosis的临床试验
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Assistance Publique Hopitaux De Marseille未知
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National Institutes of Health Clinical Center (CC)Bristol-Myers Squibb; National Institute of Allergy and Infectious Diseases (NIAID)完全的
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University of California, IrvineUniversity of California, Los Angeles; National Institute on Minority Health and Health Disparities...完全的
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National Taiwan University Hospital未知
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Fundacion para la Investigacion Biomedica del Hospital...Instituto de Salud Carlos III完全的
Sofosbuvir + Ribavirin 1的临床试验
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Catherine Anne ChappellEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); Gilead...完全的
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Radboud University Medical Center撤销
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Peking University People's Hospital尚未招聘
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Rockefeller UniversityNational Institute on Drug Abuse (NIDA)完全的
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Ain Shams UniversityCairo University完全的
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University of Maryland, BaltimoreGilead Sciences完全的