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.

Phase 3

• Conditions: Health Condition 1: K769- Liver disease, unspecified

• Registration Number: CTRI/2023/10/058236
• Lead Sponsor: Institute of Liver and Biliary Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 16 October 2023

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 <br/ ><br>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