Allopurinol Versus Atorvastatin to Prevent Complications of Liver Cirrhosis

NCT05511766 | Unknown Phase 2

• 1 other identifier: allopurinol v atorvastatin
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to compare the potential benefit of allopurinol versus atorvastatin in reducing the risk of developing cirrhosis-related complications, delaying the onset of hepatocellular carcinoma, and improving survival. Furthermore, the study aims to evaluate their impact on parents' related quality of life.

Conditions

Cirrhosis; Hepatic Encephalopathy; Ascites; Varices; SBP - Spontaneous Bacterial Peritonitis

Outcome Measures

Primary Outcomes (1)

• Number of breakthrough episodes of cirrhosis related complication during treatment

  Number of breakthrough episodes of cirrhosis related complication during 6 month

  6 months

Study Arms (3)

PLACEBO

PLACEBO COMPARATOR

Group1: (Placebo, n=50) who will receive oral placebo tablet once daily FOR 6 MONTHS

Drug: Placebo

Allopurinol

ACTIVE COMPARATOR

Group 2:(Allopurinol n=50) who will receive oral allopurinol 300 mg daily for 6 months

Drug: Allopurinol 300 MG

Simvastatin

ACTIVE COMPARATOR

Group 3: (atorvastatin n=50) who will receive oral atorvastatin 20 mg daily for 6 months

Drug: Atorvastatin 20mg

Interventions

Allopurinol 300 MG DRUG

a competitive xanthine oxidase inhibitor, reduces oxidative stress and attenuates bacterial translocation

Also known as: zyloric

Allopurinol

Atorvastatin 20mg DRUG

is lipid-lowering agent with anti-oxidative stress and anti-inflammation properties

Simvastatin

Placebo DRUG

not containing drugs

PLACEBO

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 to 75 years old
• Both sex
• Adults with cirrhosis in a stable conditions

You may not qualify if:

• Active SBP
• Renal insufficiency (serum creatinine \> 2.0 mg/dl)
• Active GIT hemorrhage

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, Egypt

RECRUITING

MeSH Terms

Conditions

Fibrosis; Hepatic Encephalopathy; Ascites; Varicose Veins

Interventions

Allopurinol; Atorvastatin

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• khadija glal

  assistant lecturer

  PRINCIPAL INVESTIGATOR

Central Study Contacts

khadija glal

CONTACT

01118969649; khadija.ahmed@pharm.tanta.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer of clinical pharmacy- Clinical pharmacy department- Faculty of pharmacy

Study Record Dates

• First Submitted: August 17, 2022
• First Posted: August 23, 2022
• Study Start: November 15, 2022
• Primary Completion: April 25, 2024
• Study Completion: January 30, 2025
• Last Updated: April 13, 2023

Record last verified: 2023-04

Locations

EG (1)