Liver Cirrhosis Clinical Trial
Official title:
Pentoxifylline Plus Carvedilol vs Carvedilol Monotherapy in Preventing New Decompensation in Stable Cirrhotic Patients With Prior Decompensation, an Open Label Randomised Control Trial
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.
Status | Not yet recruiting |
Enrollment | 180 |
Est. completion date | August 31, 2024 |
Est. primary completion date | August 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: 1. Age 18-70 years 2. Cirrhosis with prior clinical decompensation (ascites, Hepatic encephalopathy, Portal Hypertension related bleed) 3. No current clinical decompensation (for at least 3 months) Exclusion Criteria: 1. Post TIPS/ BRTO/ SAE patients 2. Post renal or liver transplantation 3. History of CAD, ischemic cardiomyopathy, PVD, ventricular arrythmia 4. Presence of clinical ascites, HE, Jaundice 5. Last clinical decompensation within 3 months. 6. Ongoing significant alcohol use 7. Active HCV/HBV infection (Detectable HCV RNA/ HBV DNA) 8. Prior Intolerance to carvedilol and hypersensitivity to Pentoxyfylline 9. Use of Pentoxifylline within last 1 month 10. AIH/PBC 11. Lack of informed consent 12. Hepatocellular carcinoma / Portal vein thrombosis/ Budd Chiari Syndrome 13. Non-cirrhotic portal hypertension 14. Ongoing CAM/Hepatotoxic drug intake 15. Known HIV infection 16. Pregnant women 17. HepatoPulmonary Syndrome |
Country | Name | City | State |
---|---|---|---|
India | Institute of Liver & Biliary Sciences. | New Delhi | Delhi |
Lead Sponsor | Collaborator |
---|---|
Institute of Liver and Biliary Sciences, India |
India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of New onset clinical decompensation (any of overt HE, variceal bleed, clinical jaundice and ascites) at 1 year in two groups. | 1 year | ||
Secondary | Precipitants, timing of new-onset decompensation at 6 months in two groups. | 6 months | ||
Secondary | Mortality at 6 months | 6 months | ||
Secondary | Precipitants, timing of new-onset decompensation at 12 months in two groups | 12 months | ||
Secondary | Mortality at 12 months in two groups. | 12 months | ||
Secondary | Changes in Liver stiffness measured by Fibroscan at 6 months | 6 months | ||
Secondary | Changes in Liver stiffness measured by Fibroscan at 12 months | 12 months | ||
Secondary | Change in ESR at 6 months in both groups | 6 months | ||
Secondary | Change in CRP at 6 months in both groups | 6 months | ||
Secondary | Change in IL 6 at 6 months in both groups | 6 months | ||
Secondary | Change in TNF Alpha at 6 months in both groups | 6 months | ||
Secondary | Change in Von Willebrand factor at 6 months in both groups | 6 months | ||
Secondary | Change in ADAM TS 13 at 6 months in both groups | 6 months | ||
Secondary | Change in ESR at 12 months in both groups. | 12 months | ||
Secondary | Change in CRP at 12 months in both groups | 12 months | ||
Secondary | Change in IL 6 at 12 months in both groups | 12 months | ||
Secondary | Change in TNF Alpha at 12 months in both groups | 12 months | ||
Secondary | Change in Von Willebrand factor at 12 months in both groups | 12 months | ||
Secondary | Change in ADAM TS 13 at 12 months in both groups | 12 months | ||
Secondary | Dose of Pentoxifylline and Carvedilol at 6 months. | 6 months | ||
Secondary | Dose of Pentoxifylline and Carvedilol at 12 months | 12 months | ||
Secondary | Number of patients with change in CTP in both groups. | 3 month, 6 month, 9 month and at end of 1 year | ||
Secondary | Number of patients with change in MELD score in both groups. | MELD minimum value=6 and maximum value=40 | 3 month, 6 month, 9 month and at end of 1 year | |
Secondary | Incidence of Hepatocellular carcinoma at 6 months between two groups. | 6 months | ||
Secondary | Incidence of Hepatocellular carcinoma at 12 months between two groups. | 12 months | ||
Secondary | Incidence of Portal vein thrombosis at 6 months between two groups. | 6 months | ||
Secondary | Incidence of Portal vein thrombosis at 12 months between two groups. | 12 months | ||
Secondary | Number of patients with adverse events in both the groups. | 6 months and 12 months |
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