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

NCT07800598 | Recruiting Phase 4 DMC

• 1 other identifier: PR-5598
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

cirrhosis; liver; hepatology

Outcome Measures

Primary Outcomes (1)

• Cirrhosis related complications

  The occurrence or exacerbation of any cirrhosis-related complications

  6 months

Study Arms (2)

Drug

ACTIVE COMPARATOR

Patients will recieve 300mg Allopurinol along with standard medical therapy

Drug: Allopurinol Tablet

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Allopurinol Tablet DRUG

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

Drug

Placebo DRUG

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

Placebo

Eligibility Criteria

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

You may qualify if:

• Adult patients (age : 18-70 years) diagnosed with Decompensated cirrhosis of liver with any etiology of cirrhosis .
• CTP score B or C .

You may not qualify if:

• Patients with known hypersensitivity or allergy to allopurinol.
• Patients with active HE or SBP or HRS-AKI or a history of any of these events within the last 4 weeks.
• Patients with advanced renal impairment (e.g., creatinine clearance \<30 mL/min).
• Pregnant or breastfeeding women.
• Patients with severe comorbidities (e.g., uncontrolled cardiovascular disease, cancer, or severe infections).
• Patients currently using medications that interact with allopurinol (e.g., azathioprine, mercaptopurine, Cyclophosphamide, Thiazide diuretics ,Warfarin, Theophyllin ).

Sponsors & Collaborators

• Bangladesh Medical University: lead

Study Sites (2)

Department of Hepatology at Bangladesh Medical University.

Dhaka, Shahbagh, 1100, Bangladesh

RECRUITING

Department of Hepatology at Bangladesh Medical University.

Dhaka, Bangladesh

RECRUITING

Related Publications (2)

• Spahr L, Bresson-Hadni S, Amann P, Kern I, Golaz O, Frossard JL, Hadengue A. Allopurinol, oxidative stress and intestinal permeability in patients with cirrhosis: an open-label pilot study. Liver Int. 2007 Feb;27(1):54-60. doi: 10.1111/j.1478-3231.2006.01382.x.

  PMID: 17241381 RESULT

• Glal KAM, El-Haggar SM, Abdel-Salam SM, Mostafa TM. Allopurinol Prevents Cirrhosis-Related Complications: A Quadruple Blind Placebo-Controlled Trial. Am J Med. 2024 Jan;137(1):55-64. doi: 10.1016/j.amjmed.2023.09.016. Epub 2023 Oct 12.

  PMID: 37832758 RESULT

MeSH Terms

Conditions

Fibrosis

Interventions

Allopurinol

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Physician

Study Record Dates

• First Submitted: August 13, 2026
• First Posted: September 2, 2026
• Study Start: September 10, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: September 2, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

BA (2)