NCT07800598 Role of Allopurinol in Prevention of Complications Related to Decompensated Cirrhosis of Liver
| NCT ID | NCT07800598 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Bangladesh Medical University |
| Condition | Cirrhoses, Liver |
| Study Type | INTERVENTIONAL |
| Enrollment | 54 participants |
| Start Date | 2025-09-10 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 54 participants in total. It began in 2025-09-10 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * • Adult patients (age : 18-70 years) diagnosed with Decompensated cirrhosis of liver with any etiology of cirrhosis . * CTP score B or C . Exclusion Criteria: * • 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 ).
Frequently Asked Questions
Who can join the NCT07800598 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Cirrhoses, Liver. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07800598 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07800598 currently recruiting?
Yes, NCT07800598 is actively recruiting participants. Visit ClinicalTrials.gov or contact Bangladesh Medical University to inquire about joining.
Where is the NCT07800598 trial being conducted?
This trial is being conducted at Dhaka, Bangladesh, Dhaka, Bangladesh.
Who is sponsoring the NCT07800598 clinical trial?
NCT07800598 is sponsored by Bangladesh Medical University. The trial plans to enroll 54 participants.