Clinical trial

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

Name

allopurinol v atorvastatin

Description

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.

Trial arms

Trial start

2022-11-15

Estimated PCD

2024-04-25

Trial end

2025-01-30

Status

Recruiting

Phase

Early phase I

Treatment

Allopurinol 300 MG

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

Arms:

Allopurinol

Other names:

zyloric

Atorvastatin 20mg

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

Arms:

Simvastatin

Placebo

not containing drugs

Arms:

PLACEBO

Size

150

Primary endpoint

Number of breakthrough episodes of cirrhosis related complication during treatment

6 months

Eligibility criteria

Inclusion Criteria: * Inclusion Criteria * Age 18 to 75 years old * Both sex * Adults with cirrhosis in a stable conditions Exclusion Criteria: * Exclusion criteria * Active SBP * Renal insufficiency (serum creatinine \> 2.0 mg/dl) * Active GIT hemorrhage

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 150, 'type': 'ESTIMATED'}}

Updated at

2023-04-13

1 organization

2 products

1 drug

5 indications

Organization

Tanta University

Product

Allopurinol

Indication

Cirrhosis