Status:
UNKNOWN
Pentoxifylline Plus Carvedilol vs Carvedilol Monotherapy in Preventing New Decompensation in Stable Cirrhotic Patients With Prior Decompensation
Lead Sponsor:
Institute of Liver and Biliary Sciences, India
Conditions:
Liver Cirrhosis
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
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...
Detailed Description
* 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%, a...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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
- AIH/PBC
- 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
Key Trial Info
Start Date :
November 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2024
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT06041932
Start Date
November 1 2023
End Date
August 31 2024
Last Update
October 3 2023
Active Locations (1)
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1
Institute of Liver & Biliary Sciences.
New Delhi, National Capital Territory of Delhi, India, 110070