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临床试验/NCT06041932
NCT06041932尚未招募不适用

Pentoxifylline Plus Carvedilol vs Carvedilol Monotherapy in Preventing New Decompensation in Stable Cirrhotic Patients With Prior Decompensation, an Open Label Randomised Control Trial

Institute of Liver and Biliary Sciences, India1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2023年11月1日最近更新:
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适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
180
试验地点
1
主要终点
Incidence of New onset clinical decompensation (any of overt HE, variceal bleed, clinical jaundice and ascites) at 1 year in two groups.
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Cirrhotics with decompensation have increased risk of morbidity and mortality. There is increased portal pressure leading to decompensation. Carvedilol is a standard therapy given to cirrhotic patient with clinically significant portal hypertension to reduce portal pressure. Pentoxifylline is a nonspecific phosphodiesterase inhibitor with anti-inflammatory properties. It reduces portal hypertension, decreases lipopolysaccharide-induced liver injury, improves nonalcoholic steatohepatitis, prevents development of HRS in ascites and SAH, prevents hepatopulmonary syndrome. Investigator want to study whether addition of pentoxifylline to carvediolol vs carvedilol monotherapy reduces the risk of mortality and further decompensation in cirrhotics with prior decompensation.

详细描述

  • Study population: Cirrhotic patients with prior decompensation at least 3 months ago
  • Study design: A Open label randomized controlled trial
  • Sample size Assuming decompensation in Arm 1 as 25%, and 10% in Arm 2, alpha error- 5, power - 80, 160 patients, 10 % lost to follow up - 180, Each arm 90 patients.
  • Intervention Arm 1 : Carvedilol Arm 2 : Pentoxiphylline plus Carvedilol
  • Monitoring and assessment

At enrollment:

    • Complete history and physical examination
  • Prior ascites, Hepatic encephalopathy, acute variceal bleed.
  • Time to prior decompensation
  • Pattern and number of prior decompensation
  • Prior spontaneous bacterial peritonitis, hydrothorax, Acute on chronic liver failure, acute kidney injury
  • Use of Non selective beta blockers, norfloxaxin, rifaximin and albumin
  • Recent herbal/drugs intake
  • History of EVL or other endotherapy
  • History of hypertension, diabetes mellitus
  • Fever , signs of sepsis
  • Examination- Sarcopenia, fraility, icterus, pedal edema

At follow-up (at 3 month, 6 month, 9 month, 12 month): Physical (preferably)

• Complete history and physical examination

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 70 Years（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •Age 18-70 years
  • •Cirrhosis with prior clinical decompensation (ascites, Hepatic encephalopathy, Portal Hypertension related bleed)
  • •No current clinical decompensation (for at least 3 months)

排除标准

  • •Post TIPS/ BRTO/ SAE patients
  • •Post renal or liver transplantation
  • •History of CAD, ischemic cardiomyopathy, PVD, ventricular arrythmia
  • •Presence of clinical ascites, HE, Jaundice
  • •Last clinical decompensation within 3 months.
  • •Ongoing significant alcohol use
  • •Active HCV/HBV infection (Detectable HCV RNA/ HBV DNA)
  • •Prior Intolerance to carvedilol and hypersensitivity to Pentoxyfylline
  • •Use of Pentoxifylline within last 1 month
  • •Lack of informed consent
  • •Hepatocellular carcinoma / Portal vein thrombosis/ Budd Chiari Syndrome
  • •Non-cirrhotic portal hypertension
  • •Ongoing CAM/Hepatotoxic drug intake
  • •Known HIV infection
  • •Pregnant women
  • •HepatoPulmonary Syndrome

研究组 & 干预措施

Pentoxiphylline plus Carvedilol

Experimental

Pentoxiphylline plus Carvedilol

干预措施: Carvedilol (Drug)

Pentoxiphylline plus Carvedilol

Experimental

Pentoxiphylline plus Carvedilol

干预措施: Pentoxifylline (Drug)

Carvedilol

Active Comparator

PCarvedilol

干预措施: Carvedilol (Drug)

结局指标

主要结局

Incidence of New onset clinical decompensation (any of overt HE, variceal bleed, clinical jaundice and ascites) at 1 year in two groups.

时间窗: 1 year

次要结局

  • Changes in Liver stiffness measured by Fibroscan at 12 months(12 months)
  • Change in ADAM TS 13 at 6 months in both groups(6 months)
  • Change in IL 6 at 12 months in both groups(12 months)
  • Precipitants, timing of new-onset decompensation at 6 months in two groups.(6 months)
  • Changes in Liver stiffness measured by Fibroscan at 6 months(6 months)
  • Change in ESR at 6 months in both groups(6 months)
  • Change in CRP at 6 months in both groups(6 months)
  • Change in Von Willebrand factor at 6 months in both groups(6 months)
  • Change in CRP at 12 months in both groups(12 months)
  • Change in ADAM TS 13 at 12 months in both groups(12 months)
  • Number of patients with change in MELD score in both groups.(3 month, 6 month, 9 month and at end of 1 year)
  • Incidence of Hepatocellular carcinoma at 6 months between two groups.(6 months)
  • Change in TNF Alpha at 12 months in both groups(12 months)
  • Change in Von Willebrand factor at 12 months in both groups(12 months)
  • Dose of Pentoxifylline and Carvedilol at 12 months(12 months)
  • Incidence of Portal vein thrombosis at 6 months between two groups.(6 months)
  • Mortality at 6 months(6 months)
  • Precipitants, timing of new-onset decompensation at 12 months in two groups(12 months)
  • Mortality at 12 months in two groups.(12 months)
  • Change in IL 6 at 6 months in both groups(6 months)
  • Change in ESR at 12 months in both groups.(12 months)
  • Incidence of Portal vein thrombosis at 12 months between two groups.(12 months)
  • Number of patients with adverse events in both the groups.(6 months and 12 months)
  • Change in TNF Alpha at 6 months in both groups(6 months)
  • Dose of Pentoxifylline and Carvedilol at 6 months.(6 months)
  • Incidence of Hepatocellular carcinoma at 12 months between two groups.(12 months)
  • Number of patients with change in CTP in both groups.(3 month, 6 month, 9 month and at end of 1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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