In patients of cirrhosis with prior decompensation who do not have any evidence of recent decompensation whether addition of pentoxifylline to carvedilol vs carvediolol alone improves the outcome.

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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/10/058236

Enrollment

180

Registered

2023-10-04

Start date

Unknown

Completion date

Unknown

Last updated

2023-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K769- Liver disease, unspecified

Interventions

Intervention1: Carvedilol with pentoxifylline: Carvedilol 3.125 mg dose to maximum 12.5 mg BD and Pentoxifylline maximum 400 mg TDS Duration: 1 year Route: Oral Control Intervention1: Carvedilol: Carv

Eligibility

Inclusion criteria

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 1 year) 4. CTP A at enrollment

Exclusion criteria

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.Hepato Pulmonary Syndrome

Design outcomes

Primary

Measure	Time frame
Incidence of New onset clinical decompensation (any of overt HE, variceal bleed, clinical jaundice & ascites) at 1 year in two groups.Timepoint: 1 year	—

Secondary

Measure	Time frame
Change in CTP in both groupsTimepoint: 3 month, 6 month, 9 month & at end of 1 year;Change in MELD score in both groupsTimepoint: 3 month, 6 month, 9 month & at end of 1 year;Development of HCC in two groupsTimepoint: 6 & 12 months;Development of PVT in two groupsTimepoint: 6 & 12 months;Non-invasive Predictors of decompensation, changes in markers of systemic & endothelial inflammation of decompensation Timepoint: 6 & 12 months;Precipitants, timing of new-onset decompensation & mortality in two groupsTimepoint: 6 & 12 months;Tolerance & side effects of pentoxifylline & carvedilolTimepoint: 6 & 12 months	—

Measure

Time frame

Change in CTP in both groupsTimepoint: 3 month, 6 month, 9 month & at end of 1 year;Change in MELD score in both groupsTimepoint: 3 month, 6 month, 9 month & at end of 1 year;Development of HCC in two groupsTimepoint: 6 & 12 months;Development of PVT in two groupsTimepoint: 6 & 12 months;Non-invasive Predictors of decompensation, changes in markers of systemic & endothelial inflammation of decompensation Timepoint: 6 & 12 months;Precipitants, timing of new-onset decompensation & mortality in two groupsTimepoint: 6 & 12 months;Tolerance & side effects of pentoxifylline & carvedilolTimepoint: 6 & 12 months

—

Countries

India

Contacts

Public ContactDr Ankur Jindal

Institute of Liver and Biliary Sciences

ankur.jindal3@gmail.com01146300000

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026