Statin Impact on Hepatic Decompensation

September 9, 2026 updated by: Khadija Ahmed Mhrose Glal, Tanta University

the Impact of Statin on Cirrhotic Patients

The study aims to evaluate the impact of statin on hepatic decompensation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Tanta, Egypt
        • Tanta University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: PLACEBO
placebo formula
Drug: Placebo
placebo arm
Active Comparator: statin
atorvastatin tablets
Drug: Atorvastatin 20mg
active arm
Other Names:
  • atorvastatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
impact on decompensation
Time Frame: 6 months
change in recurrence of cirrhosis related complications
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Investigators

  • Principal Investigator: khadija glal, assistant lecturer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2022

Primary Completion (Actual)

February 25, 2023

Study Completion (Actual)

February 25, 2023

Study Registration Dates

First Submitted

September 29, 2022

First Submitted That Met QC Criteria

September 29, 2022

First Posted (Actual)

October 3, 2022

Study Record Updates

Last Update Posted (Actual)

September 14, 2026

Last Update Submitted That Met QC Criteria

September 9, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Statin and iver cirrhosis

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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