NCT05563389

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_2 quality-of-life

Timeline
Completed

Started Jun 2022

Shorter than P25 for phase_2 quality-of-life

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 29, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 3, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 25, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2023

Completed
Last Updated

September 14, 2026

Status Verified

September 1, 2026

Enrollment Period

9 months

First QC Date

September 29, 2022

Last Update Submit

September 9, 2026

Conditions

Quality of Lifethe Incidence of Whole Complications Resultant From Decompensated Liver

Keywords

Atorvastatin, Cirrhosis-related complications, Hepato-renal syndrome, oxidative stress.

Outcome Measures

Primary Outcomes (1)

  • impact on decompensation

    change in recurrence of cirrhosis related complications

    6 months

Study Arms (2)

PLACEBO

PLACEBO COMPARATOR

placebo formula

Drug: Placebo

statin

ACTIVE COMPARATOR

atorvastatin tablets

Drug: Atorvastatin 20mg

Interventions

Atorvastatin 20mgDRUG

active arm

Also known as: atorvastatin
statin
PlaceboDRUG

placebo arm

PLACEBO

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta University

Tanta, Egypt

Location

Related Publications (1)

  • 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.

    PMID: 41865069DERIVED

MeSH Terms

Conditions

Hepatorenal Syndrome

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Study Officials

  • khadija glal

    assistant lecturer

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Trial participants, investigators, care providers and outcome assessors were blinded to treatment allocation. Atorvastatin and placebo tablet were pre-filled in capsule and put into nontransparent sealed bottle to be identical in appearance. Unique randomization codes were set for each participant to avoid inadvertent loss of blinding for all participants if one is unblinded. Data analysis and manuscript writing were performed after unblinding when data had been cleaned for primary and secondary endpoints and adverse events (AEs).
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer of clinical pharmacy- Clinical pharmacy department- Faculty of pharmacy

Study Record Dates

First Submitted

September 29, 2022

First Posted

October 3, 2022

Study Start

June 15, 2022

Primary Completion

February 25, 2023

Study Completion

February 25, 2023

Last Updated

September 14, 2026

Record last verified: 2026-09

Locations

EG(1)