NCT01676597Unknown不适用
Efficacy of Pentoxifylline and Rifaximin Combination in Pentoxifylline Refractory Clinical and Subclinical Hepatopulmonary Syndrome
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Complete response after 3 months of treatment
研究概览
简要总结
- The study will be a prospective open labelled double blinded randomized controlled study.
- The study will be conducted on patients admitted to Department of Hepatology from 2012 to 2014 at Institute of Liver and Biliary Sciences, New Delhi
- Patients diagnosed as having clinical or subclinical hepatopulmonary syndrome will be started on oral pentoxifylline therapy 400 mg thrice daily for 12 weeks.
- Patients not responding to this therapy will be given divided into 2 arms with one arm receiving additional Tab Rifaximin 400 mg thrice daily or placebo for 12 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 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Evidence of portal hypertension (esophagogastric varices or portal hypertensive gastropathy identified on esophagogastroduodenoscopy, and/or varices seen on computerized tomography scan or ultrasound, and/or splenomegaly with no other explanation, and/or ascites with no other explanation)
- •Intrapulmonary vascular dilatations (IPVDs) diagnosed on contrast echocardiogram (CE)
- •AaDO2 > 15 mm Hg on standing room air arterial blood gas (ABG)
- •Ability and willingness to give informed consent
排除标准
- •Age < 18 or > 64
- •Intrinsic significant cardiopulmonary disease
- •Inability to perform pulmonary function tests
- •Moderate to severe Pulmonary hypertension
- •Advanced hepatic encephalopathy
- •Inadequate echocardiographic window to allow for accurate transthoracic contrast echocardiography
- •Antibiotic use within the last one month
- •Listed for liver transplant in next 4 weeks
- •Current use of exogenous nitrates
- •Active bacterial infections
- •Known malignancy
- •Known intolerance to Pentoxifylline or rifaximin
研究组 & 干预措施
rifaximin and pentoxifylline
Experimental
Tab Rifaximin 400 mg thrice daily + Pentoxifylline 400 mg thrice daily for 12 weeks
干预措施: Pentoxifylline and placebo (Drug)
pentoxifylline and placebo
Active Comparator
Tab Pentoxifylline 400 mg thrice daily + Placebo thrice daily for 12 weeks
干预措施: pentoxifylline and rifaximin (Drug)
结局指标
主要结局
Complete response after 3 months of treatment
时间窗: 3 months
次要结局
- Development of serious adverse effects leading to withdrawal of the drug(3 months)
研究者
研究点 (1)
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