Cirrhoses, LiverPhase 1/2NCT07033533
Allopurinol and Pathogenesis of Cirrhosis
A Phase 1/2 study testing Allopurinol Tablet in people with Cirrhoses, Liver, run by Tanta University at 1 site in Egypt.
Trial summary
Hepatic decompensation is a common healthcare issue . This study was conducted to investigate how allopurinol can interfere with the pathological mechanisms of HD. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cirrhoses, Liver
- What is being tested?
- Allopurinol Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jun 2022to 1 Mar 2023
- Phase
- Phase 1/2
- 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 18-75 both sex
Who cannot join
- active GIT bleeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Allopurinol Interferes With the Pathological Mechanisms of Hepatic Decompensation
Hepatic decompensation is a common healthcare issue
. This study was conducted to investigate how allopurinol can interfere with the pathological mechanisms of HD.
- Conditions
- Cirrhoses, Liver
- Being tested
- Allopurinol Tablet, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allopurinol TabletDrug
allopurinol 300
PlaceboDrug
placebo tablet
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | placebo Receives: Drug: Placebo |
| allopurinol | Active comparator | Not described Receives: Drug: Allopurinol Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Levels of gut barrier and microbial translocation biomarkers, including zonulin, lipopolysaccharide (LPS), NFκB, MMP-13, and malondialdehyde (MDA), measured in serum/plasma.
Levels of gut barrier and microbial translocation biomarkers, including zonulin, lipopolysaccharide (LPS), NFκB, MMP-13, and malondialdehyde (MDA), measured in serum/plasma.
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 posted24 Jun 2025
- Study start15 Jun 2022
- Primary completion15 Feb 2023
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cirrhoses, LiverStudies 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 110 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07033533
- Sponsor's protocol ID
- ALLOU
- Status last verified
- Nov 2026
- First submitted
- 14 Jun 2025
- Last updated
- 4 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Allopurinol Interferes With the Pathological Mechanisms of Hepatic Decompensation
- ClinicalTrials.gov ID
- NCT07033533
- Acronym / sponsor ID
- ALLOU
- Conditions
- Cirrhoses, Liver
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 15 Jun 2022 (actual)
- Primary completion
- 15 Feb 2023 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 24 Jun 2025 (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.
Hepatic decompensation is a common healthcare issue
. This study was conducted to investigate how allopurinol can interfere with the pathological mechanisms of HD.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Drug: Placeboplacebo |
| allopurinol | Active comparator | Drug: Allopurinol Tablet |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- age 18-75 both sex
Key exclusion criteria (1 listed)
- active GIT bleeding
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 Tabletallopurinol 300 | Drug | allopurinol |
| Placeboplacebo tablet | Drug | placebo |
Primary outcome
Levels of gut barrier and microbial translocation biomarkers, including zonulin, lipopolysaccharide (LPS), NFκB, MMP-13, and malondialdehyde (MDA), measured in serum/plasma.
Time frame: 6 MONTHS
Levels of gut barrier and microbial translocation biomarkers, including zonulin, lipopolysaccharide (LPS), NFκB, MMP-13, and malondialdehyde (MDA), measured in serum/plasma.
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 4 Nov 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Allopurinol Tablet in people with Cirrhoses, Liver, 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 1 inclusion and 1 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 4 Nov 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Levels of gut barrier and microbial translocation biomarkers, including zonulin, lipopolysaccharide (LPS), NFκB, MMP-13, and malondialdehyde (MDA), measured in serum/plasma. (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 4 Nov 2026.