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Role of Allopurinol in Prevention of Complications Related to Decompensated Cirrhosis of Liver

NCT07800598 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2026-09-02

No results posted yet for this study

Summary

Cirrhosis, a leading cause of global mortality, progresses to life-threatening complications like ascites, hepatic encephalopathy, and hepatorenal syndrome. Oxidative stress and gut-liver axis dysfunction drive disease progression. Allopurinol, a xanthine oxidase inhibitor, has shown potential in reducing complications in cirrhosis, but robust clinical evidence is lacking. This study will evaluate allopurinol's efficacy in preventing complications in decompensated cirrhosis.

This study aims to assess whether allopurinol reduces cirrhosis-related complications (ascites, variceal bleeding, hepatic encephalopathy, SBP, HRS-AKI) and improves MELD/CTP scores in Child-Pugh B/C cirrhosis patients.

This study will select 54 patients with decompensated cirrhosis (Child-Pugh B/C). Patients aged 18-70 years, with any etiology of cirrhosis (viral, alcoholic, NAFLD). Patients with acute decompensation, allopurinol hypersensitivity, advanced renal impairment (CrCl \<30 mL/min), pregnancy, or concurrent use of interacting drugs.

This randomized controlled trial will be conducted in Hepatology department of BMU after IRB clearance. 54 patients aged 18 to 70 years with Child-Pugh class B or C cirrhosis, admitted to or attending the Outpatient Department of Hepatology at Bangladesh Medical University will be enrolled. After thorough clinical and laboratory evaluation and informed consent, patients will be randomized in a either an allopurinol treatment group or a standard care group with placebo ; 27 participants in each group by block randomization. one group will receive oral Allopurinol (titrated from 100 mg to 300 mg daily for six months) along with standard medical therapy. Another Group will receive same dose of Placebo along with standard medical therapy . Patients will be followed at 6 month to see the progression of cirrhosis-related complications. Data collection will include clinical parameters, laboratory tests, imaging, and endoscopy.

All data will be analyzed using the statistical package SPSS (version 29.0 IBM Corp: Armonk NY, USA). Demographic and baseline clinical characteristics will be analyzed using the chi-square test for categorical variables. For continuous variables that follow a normal distribution, the Student's t-test will be applied. Time to first complication will be analyzed using the Cox proportional hazards model, and Kaplan-Meier curves will be used to compare event-free survival between groups.

The study protocol is approved by the institutional review board. Written informed consent (Bengali version) will be obtained, ensuring confidentiality and voluntary participation. Participants may withdraw anytime.

If effective, allopurinol will offer a low-cost, widely accessible therapy to prevent complications and improve survival in decompensated cirrhosis. To the best of my knowledge this is the first study in Bangladesh to evaluate the efficacy of Allopurinol in prevention of cirrhosis associated complications.

Conditions

  • Cirrhoses, Liver
  • Decompensated Cirrhosis of Liver

Interventions

DRUG

Allopurinol Tablet

Patients will recieve 300 mg of Allopurinol daily along with standard medical therapy

DRUG

Placebo

Patients will recieve same dose of matched Placebo along with standard medical therapy

Sponsors & Collaborators

  • Bangladesh Medical University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-10
Primary Completion
2026-12-31
Completion
2027-07-31

Countries

  • Bangladesh

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07800598 on ClinicalTrials.gov