Quality of LifePhase 2/3NCT05563389
Statin Impact on Hepatic Decompensation
A Phase 2/3 study testing Atorvastatin 20mg in people with Quality of Life and the Incidence of Whole Complications Resultant From Decompensated Liver, run by Tanta University at 1 site in Egypt.
Trial summary
The study aims to evaluate the impact of statin on hepatic decompensation. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Quality of Life, the Incidence of Whole Complications Resultant From Decompensated Liver
- What is being tested?
- Atorvastatin 20mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jun 2022to 25 Feb 2023
- 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
Admissibility measures were age ranged from 18 to 75, with a medical diagnosis of decompensated liver cirrhosis built on standard clinical symptoms, laboratory tests, imaging appearances and/or liver biopsy. Decompensation of the disease was labeled by to the lowest degree having one episode of severe complications, including ascites, SBP, jaundice, EGVB and HE.8 All participants were ready to be enrolled and had signed up the informed consent.
The foremost exclusion criteria involved the following: (1) life-deadly leukocytopenia (WBCs < 1 × 109/l); (2) Pregnant women or lactating mother; (3) patients diagnosed to have primary or secondary liver cancer.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: the Impact of Statin on Cirrhotic Patients
The study aims to evaluate the impact of statin on hepatic decompensation.
Read the detailed description
Cirrhosis is the late stage of liver damage and possess two phases:. The shift from compensated to decompensated cirrhosis is characterized by the onset of complications) which are associated with substantial morbidity and negative Impact on quality of life (QOL)Cirrhosis and its complications have a substantial economic, social, and personal impact on affected patients, as well as their families and caregivers
- Being tested
- Atorvastatin 20mg, Placebo
- Keywords
- Atorvastatin, Cirrhosis-related complications, Hepato-renal syndrome, oxidative stress.
- Medical subject headings
- Hepatorenal Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atorvastatin 20mgDrug
Also called atorvastatin
active arm
PlaceboDrug
placebo arm
| Study group | Role | What they receive |
|---|---|---|
| PLACEBO | Placebo comparator | placebo formula Receives: Drug: Placebo |
| statin | Active comparator | atorvastatin tablets Receives: Drug: Atorvastatin 20mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
impact on decompensation
change in recurrence of cirrhosis related complications
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 posted3 Oct 2022
- Study start15 Jun 2022
- Primary completion25 Feb 2023
- Study completion25 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- 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
- 100 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
- NCT05563389
- Sponsor's protocol ID
- Statin and iver cirrhosis
- Status last verified
- Sep 2026
- First submitted
- 29 Sep 2022
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Glal KAM, El-Haggar SM, Abdel-Salam SM, Mostafa TM. Atorvastatin reduces recurrent decompensation events in advanced cirrhosis in a randomized placebo-controlled trial. Sci Rep. 2026 Mar 21;16(1):9669. doi: 10.1038/s41598-026-41326-4.
PubMed 41865069
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Impact of Statin on Cirrhotic Patients
- ClinicalTrials.gov ID
- NCT05563389
- Acronym / sponsor ID
- Statin and iver cirrhosis
- Keywords
- Atorvastatin, Cirrhosis-related complications, Hepato-renal syndrome, oxidative stress.
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 15 Jun 2022 (actual)
- Primary completion
- 25 Feb 2023 (actual)
- Study completion
- 25 Feb 2023 (actual)
- First posted
- 3 Oct 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 evaluate the impact of statin on hepatic decompensation.
Detailed description
Cirrhosis is the late stage of liver damage and possess two phases:. The shift from compensated to decompensated cirrhosis is characterized by the onset of complications) which are associated with substantial morbidity and negative Impact on quality of life (QOL)Cirrhosis and its complications have a substantial economic, social, and personal impact on affected patients, as well as their families and caregivers
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 formula |
| statin | Active comparator | Drug: Atorvastatin 20mgatorvastatin tablets |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Atorvastatin 20mgAlso: atorvastatinactive arm | Drug | statin |
| Placeboplacebo arm | Drug | PLACEBO |
Primary outcome
impact on decompensation
Time frame: 6 months
change in recurrence of cirrhosis related complications
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 14 Sep 2026.
- Derived from this study: PubMed 41865069Glal KAM, El-Haggar SM, Abdel-Salam SM, Mostafa TM. Atorvastatin reduces recurrent decompensation events in advanced cirrhosis in a randomized placebo-controlled trial. Sci Rep. 2026 Mar 21;16(1):9669. doi: 10.1038/s41598-026-41326-4.
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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 Atorvastatin 20mg in people with Quality of Life and the Incidence of Whole Complications Resultant From Decompensated 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?
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 14 Sep 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?
impact on decompensation (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05563389, which also lists 1 linked publication.
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 14 Sep 2026.