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Clinical Trials/NCT05511766
NCT05511766CompletedPhase 2

The Potential Role of Allopurinol Versus Atorvastatin to Prevent Complications of Liver Cirrhosis: A Quadruple Blind Clinical Study

Tanta University1 site in 1 country150 target enrollmentStarted: November 15, 2022Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
150
Locations
1
Primary Endpoint
recurrence number

Study Overview

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.

Detailed Description

Cirrhosis is the late stage of liver damage and possess two phases: a compensated phase with favorable prognosis and a decompensated phase with high mortality rate1.The shift from compensated to decompensated cirrhosis is characterized by the onset of complications, including ascites, hepatic encephalopathy (HE), variceal bleeding, and spontaneous bacterial peritonitis (SBP) which are associated with substantial morbidity and negative Impact on quality of life (QOL)2.

The gut microbiota plays an important role in cirrhosis and development of cirrhosis-related complications3.

Indeed, translocation of endotoxins is increased in patients with cirrhosis and patients with more severe cirrhosis (i.e. Patients with decompensated cirrhosis, hospitalized patients) had significantly greater serum endotoxin concentrations that mediate complications of cirrhosis4.

Intestinal permeability plays a role in the development of bacterial translocation and may be involved in the development of complications of cirrhosis5. This 'leaky gut' phenomenon increases with the degree of liver failure and is particularly prominent in patients with cirrhosis who have experienced severe septic complications and has been implicated in the hepatic production of endotoxin-associated proinflammatory cytokines6.

Intestinal mucosa alterations at the subcellular level have been reported in experimental cirrhosis, in relation to an increased oxidative stress due to overactivity in the enzyme xanthine oxidase7.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Inclusion Criteria
  • •Age 18 to 75 years old
  • •Adults with cirrhosis in a stable conditions

Exclusion Criteria

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

Arms & Interventions

PLACEBO

Placebo Comparator

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

Intervention: Placebo (Drug)

Simvastatin

Active Comparator

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

Intervention: Atorvastatin 20mg (Drug)

Allopurinol

Active Comparator

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

Intervention: Allopurinol 300 MG (Drug)

Outcomes

Primary Outcomes

recurrence number

Time Frame: 6 months

acute decompensation events recurrence numbers

Secondary Outcomes

  • validate a linical prediction model(6 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Khadija Ahmed Mhrose Glal

Assistant lecturer of clinical pharmacy- Clinical pharmacy department- Faculty of pharmacy

Tanta University

Study Sites (1)

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