Statin Impact on Hepatic Decompensation | NCT05563389

Studies
Statin Impact on Hepatic Decompensation

NCT05563389

Sponsor

Tanta University

Status

Completed

Last Update Posted

Apr 3, 2024Actual

Enrollment

100Actual

Phase

Phase 2Phase 3

Conditions

Quality of Life

Interventions

Atorvastatin 20mg
Placebo

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 15, 2022Actual

Primary Completion Date

Feb 25, 2023Actual

Completion Date

Feb 25, 2023Actual

First Submitted Date

Sep 29, 2022

First Submission Date that Met QC Criteria

Sep 29, 2022

First Posted Date

Oct 3, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 2, 2024

Last Update Posted Date

Apr 3, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Khadija Ahmed Mhrose Glal, Assistant lecturer of clinical pharmacy- Clinical pharmacy department- Faculty of pharmacy, Tanta UniversityPrincipal Investigator

Lead Sponsor

Tanta UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PLACEBO	Placebo Comparator	placebo formula	Drug: Placebo
statin	Active Comparator	atorvastatin tablets	Drug: Atorvastatin 20mg

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Atorvastatin 20mg	Drug	active arm	statin	atorvastatin

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

cirrhosis adult both sex

Exclusion Criteria:

renal insufficiency

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
khadija glal	assistant lecturer	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tanta University		Tanta			Egypt

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
41865069	Derived	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.

ID	Term
D011758	Pyrroles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds