Pentoxifylline Plus Carvedilol vs Carvedilol Monotherapy in Preventing New Decompensation in Stable Cirrhotic Patients With Prior Decompensation

NCT06041932 | Unknown

• 1 other identifier: ILBS-Cirrhosis-62
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Liver Cirrhosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (27)

• Precipitants, timing of new-onset decompensation at 6 months in 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

• Changes in Liver stiffness measured by Fibroscan at 6 months

  6 months

Study Arms (2)

Pentoxiphylline plus Carvedilol

EXPERIMENTAL

Pentoxiphylline plus Carvedilol

Drug: Carvedilol; Drug: Pentoxifylline

Carvedilol

ACTIVE COMPARATOR

PCarvedilol

Drug: Carvedilol

Interventions

Carvedilol DRUG

Carvedilol

Carvedilol; Pentoxiphylline plus Carvedilol

Pentoxifylline DRUG

Pentoxiphylline

Pentoxiphylline plus Carvedilol

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver & Biliary Sciences.

New Delhi, National Capital Territory of Delhi, 110070, India

Location

MeSH Terms

Conditions

Liver Cirrhosis

Interventions

Carvedilol; Pentoxifylline

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 3-Ring; Theobromine; Xanthines; Purinones; Purines

Central Study Contacts

Dr Jaifrin Daniel, MD

CONTACT

01146300000; jdaniel.m07@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2023
• First Posted: September 18, 2023
• Study Start: November 1, 2023
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: October 3, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)