CirrhosisPhase 2/3NCT05511766
Allopurinol Versus Atorvastatin to Prevent Complications of Liver Cirrhosis
A Phase 2/3 study testing Allopurinol 300 MG and Atorvastatin 20mg in people with Cirrhosis and Hepatic Encephalopathy, run by Tanta University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cirrhosis, Hepatic Encephalopathy, Ascites
- What is being tested?
- Allopurinol 300 MG and Atorvastatin 20mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Nov 2022to 25 Jan 2026
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 75 years old
- Both sex
- Adults with cirrhosis in a stable conditions
Who cannot join
- Active SBP
- Renal insufficiency (serum creatinine > 2.0 mg/dl)
- Active GIT hemorrhage
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Potential Role of Allopurinol Versus Atorvastatin to Prevent Complications of Liver Cirrhosis: A Quadruple Blind Clinical Study
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.
Read the 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.
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 scavenger8.
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 9.
Statins are one class of medications being studied to determine their effect on progression and decompensation of CLDs. Besides their lipid-lowering effects, statins also decrease oxidative stress and inflammation by decreasing activation of inflammatory cells, and improve endothelial function by increasing synthesis of nitric oxide, restoring the function of endothelial cells, and increasing the number of endothelial progenitors cells10. Recent studies have suggested an association between statin use and hepatic decompensation in patients with CLDs11.
Cirrhosis and its complications have a substantial economic, social, and personal impact on affected patients, as well as their families and caregivers12. Given that the number of primary prophylaxis treatments that prevent complications of cirrhosis is limited. Therefore, it is important to examine whether allopurinol and statins have the potential to reduce the risk of developing several complications of cirrhosis, including HE, SBP, variceal bleeding, hepatocellular carcinoma (HCC) and hepatorenal syndrome.
- Conditions
- Cirrhosis, Hepatic Encephalopathy, Ascites, Varices, SBP - Spontaneous Bacterial Peritonitis
- Being tested
- Allopurinol 300 MG, Atorvastatin 20mg, Placebo
- Medical subject headings
- Fibrosis, Hepatic Encephalopathy, Ascites, Varicose Veins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allopurinol 300 MGDrug
Also called zyloric
a competitive xanthine oxidase inhibitor, reduces oxidative stress and attenuates bacterial translocation
Atorvastatin 20mgDrug
is lipid-lowering agent with anti-oxidative stress and anti-inflammation properties
PlaceboDrug
not containing drugs
| Study group | Role | What they receive |
|---|---|---|
| PLACEBO | Placebo comparator | Group1: (Placebo, n=50) who will receive oral placebo tablet once daily FOR 6 MONTHS Receives: Drug: Placebo |
| Allopurinol | Active comparator | Group 2:(Allopurinol n=50) who will receive oral allopurinol 300 mg daily for 6 months Receives: Drug: Allopurinol 300 MG |
| Simvastatin | Active comparator | Group 3: (atorvastatin n=50) who will receive oral atorvastatin 20 mg daily for 6 months Receives: Drug: Atorvastatin 20mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrence number
acute decompensation events recurrence numbers
Measured: 6 months
Secondary outcomes (1)
validate a linical prediction model
validate a treatment-informed clinical prediction model
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2022
- Study start15 Nov 2022
- Primary completion25 Jan 2026
- Study completion25 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khadija Ahmed Mhrose Glal, Tanta University
- Investigators
- khadija glal, Principal investigator, assistant lecturer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05511766
- Sponsor's protocol ID
- allopurinol v atorvastatin
- Status last verified
- Aug 2026
- First submitted
- 17 Aug 2022
- Last updated
- 11 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Potential Role of Allopurinol Versus Atorvastatin to Prevent Complications of Liver Cirrhosis: A Quadruple Blind Clinical Study
- ClinicalTrials.gov ID
- NCT05511766
- Acronym / sponsor ID
- allopurinol v atorvastatin
- Conditions
- Cirrhosis, Hepatic Encephalopathy, Ascites, Varices, SBP - Spontaneous Bacterial Peritonitis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 15 Nov 2022 (actual)
- Primary completion
- 25 Jan 2026 (actual)
- Study completion
- 25 Jan 2026 (actual)
- First posted
- 23 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 scavenger8.
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 9.
Statins are one class of medications being studied to determine their effect on progression and decompensation of CLDs. Besides their lipid-lowering effects, statins also decrease oxidative stress and inflammation by decreasing activation of inflammatory cells, and improve endothelial function by increasing synthesis of nitric oxide, restoring the function of endothelial cells, and increasing the number of endothelial progenitors cells10. Recent studies have suggested an association between statin use and hepatic decompensation in patients with CLDs11.
Cirrhosis and its complications have a substantial economic, social, and personal impact on affected patients, as well as their families and caregivers12. Given that the number of primary prophylaxis treatments that prevent complications of cirrhosis is limited. Therefore, it is important to examine whether allopurinol and statins have the potential to reduce the risk of developing several complications of cirrhosis, including HE, SBP, variceal bleeding, hepatocellular carcinoma (HCC) and hepatorenal syndrome.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PLACEBO | Placebo comparator | Drug: PlaceboGroup1: (Placebo, n=50) who will receive oral placebo tablet once daily FOR 6 MONTHS |
| Allopurinol | Active comparator | Drug: Allopurinol 300 MGGroup 2:(Allopurinol n=50) who will receive oral allopurinol 300 mg daily for 6 months |
| Simvastatin | Active comparator | Drug: Atorvastatin 20mgGroup 3: (atorvastatin n=50) who will receive oral atorvastatin 20 mg daily for 6 months |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 to 75 years old
- Both sex
- Adults with cirrhosis in a stable conditions
Key exclusion criteria (3 listed)
- Active SBP
- Renal insufficiency (serum creatinine > 2.0 mg/dl)
- Active GIT hemorrhage
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Allopurinol 300 MGAlso: zylorica competitive xanthine oxidase inhibitor, reduces oxidative stress and attenuates bacterial translocation | Drug | Allopurinol |
| Atorvastatin 20mgis lipid-lowering agent with anti-oxidative stress and anti-inflammation properties | Drug | Simvastatin |
| Placebonot containing drugs | Drug | PLACEBO |
Primary outcome
recurrence number
Time frame: 6 months
acute decompensation events recurrence numbers
1 secondary outcome
validate a linical prediction model
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
khadija glal principal investigator
assistant lecturer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Allopurinol 300 MG and Atorvastatin 20mg in people with Cirrhosis and Hepatic Encephalopathy, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
recurrence number (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026; AzTrials last refreshed its copy on 8 Nov 2026.