Allopurinol to Prevent Cirrhosis Related Morbidities
Primary Purpose
Cirrhosis
Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Placebo
Allopurinol 300 MG
Sponsored by
About this trial
This is an interventional prevention trial for Cirrhosis
Eligibility Criteria
Inclusion Criteria:
- ge 18 to 75 years old Both sex Adults with cirrhosis in a stable conditions
Exclusion Criteria:
- Active SBP Renal insufficiency (serum creatinine > 2.0 mg/dl) Active GIT hemorrhage
Sites / Locations
- Faculty of Pharmacy
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
placebo
allopurinol
Arm Description
Group1: (Placebo, n=50) who will receive oral placebo tablet once daily FOR 6 MONTHS
Group 2:(Allopurinol n=50) who will receive oral allopurinol 300 mg daily for 6 months
Outcomes
Primary Outcome Measures
morbidities
occurrence or exacerbation of complication
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05545670
Brief Title
Allopurinol to Prevent Cirrhosis Related Morbidities
Official Title
Allopurinol Impact on Cirrhosis Related Complications
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
June 15, 2022 (Actual)
Primary Completion Date
February 15, 2023 (Actual)
Study Completion Date
March 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The study aims to compare the potential benefit of allopurinol 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 rate.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).
The gut microbiota plays an important role in cirrhosis and development of cirrhosis-related complications.
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 cirrhosis.
Intestinal permeability plays a role in the development of bacterial translocation and may be involved in the development of complications of cirrhosis. 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 cytokines.
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 oxidase.
Allopurinol, a competitive xanthine oxidase inhibitor, reduces oxidative stress and attenuates bacterial translocation in portal hypertensive animals, suggesting that the damaging effects of oxygen-derived free radicals and peroxidation on mucosal cells may be counteracted by a free radical scavenger.
In 2007, a pilot study demonstrated that allopurinol in patients with cirrhosis is associated with a significant reduction in oxidative stress but no effect on intestinal permeability and inflammatory markers. The study duration was only 10 days and therefore another study with a long period of time is essential.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cirrhosis
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Group1: (Placebo, n=50) who will receive oral placebo tablet once daily FOR 6 MONTHS
Arm Title
allopurinol
Arm Type
Active Comparator
Arm Description
Group 2:(Allopurinol n=50) who will receive oral allopurinol 300 mg daily for 6 months
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
not containing drugs
Intervention Type
Drug
Intervention Name(s)
Allopurinol 300 MG
Intervention Description
a competitive xanthine oxidase inhibitor, reduces oxidative stress and attenuates bacterial translocation
Primary Outcome Measure Information:
Title
morbidities
Description
occurrence or exacerbation of complication
Time Frame
6 moths
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
ge 18 to 75 years old Both sex Adults with cirrhosis in a stable conditions
Exclusion Criteria:
Active SBP Renal insufficiency (serum creatinine > 2.0 mg/dl) Active GIT hemorrhage
Facility Information:
Facility Name
Faculty of Pharmacy
City
Tanta
ZIP/Postal Code
31679
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Allopurinol to Prevent Cirrhosis Related Morbidities
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