NCT07459972

Brief Summary

This prospective open-label parallel pilot clinical study evaluated the efficacy and safety of physiologically based pharmacokinetic (PBPK)-guided simvastatin dosing in Child-Pugh A and B cirrhotic patients with portal hypertension over a 3-month period. Twenty-two patients were enrolled following screening, and portal hemodynamic, laboratory, and safety parameters were assessed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Mar 2024

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

March 15, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2025

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 4, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 10, 2026

Completed
Last Updated

March 11, 2026

Status Verified

March 1, 2026

Enrollment Period

1 year

First QC Date

March 4, 2026

Last Update Submit

March 9, 2026

Conditions

Liver CirrhosisPortal Hypertension Related to Cirrhosis

Keywords

Liver CirrhosisPortal HypertensionSimvastatin

Outcome Measures

Primary Outcomes (6)

  • Change in Portal Vein Diameter (mm)

    Portal vein diameter will be measured as a Doppler ultrasound parameter to evaluate changes related to portal hypertension

    3 months

  • Change in Portal Vein Velocity (cm/s)

    Portal vein velocity will be assessed as an indicator reflecting changes in portal hypertension

    3 months

  • Change in Hepatic Artery Resistance Index (HARI)

    The Hepatic Artery Resistance Index will be measured as a Doppler-based marker associated with changes in portal hypertension

    3 months

  • Change in Congestion Index (CI) (cm/ [cm/s2])

    The congestion index will be evaluated as a Doppler-derived surrogate marker for portal hypertension severity

    3 months

  • Change in Modified Vascular Liver Index (MVLI) (cm/s)

    MVLI will be measured as part of the Doppler assessment reflecting changes in portal hypertension

    3 months

  • Change in Platelet Count (×10⁹/L)

    Platelet count will be assessed as a hematologic surrogate marker associated with portal hypertension.

    3 months

Secondary Outcomes (1)

  • Incidence of adverse effects related to Simvastatin

    3 months

Study Arms (2)

Group 1_Child-Pugh A

EXPERIMENTAL

10 patients with Child-Pugh A received Simvastatin 15 mg once daily.

Drug: Simvastatin 15 mg

Group 2_Child-Pugh B

EXPERIMENTAL

12 patients with Child-Pugh B received Simvastatin 5 mg once daily.

Drug: Simvastatin 5 mg

Interventions

Simvastatin 15 mgDRUG

Simvastatin is an HMG-CoA reductase inhibitor that improves endothelial nitric oxide bioavailability and reduces intrahepatic vascular resistance, thereby potentially lowering portal pressure.

Group 1_Child-Pugh A
Simvastatin 5 mgDRUG

Simvastatin is an HMG-CoA reductase inhibitor that improves endothelial nitric oxide bioavailability and reduces intrahepatic vascular resistance, thereby potentially lowering portal pressure.

Group 2_Child-Pugh B

Eligibility Criteria

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

You may qualify if:

  • Adult patients aged ≥ 18 years
  • Confirmed diagnosis of liver cirrhosis (clinical, laboratory, or imaging evidence)
  • Evidence of portal hypertension (clinical findings and/or Doppler ultrasound measurements)
  • No previous history of variceal bleeding
  • Child-Pugh class A or B

You may not qualify if:

  • Active hepatocellular carcinoma
  • Severe renal impairment (eGFR \< 30 mL/min/1.73 m²)
  • Baseline creatine kinase (CK) \> 3 × upper limit of normal
  • Known hypersensitivity to simvastatin
  • Current therapy with strong CYP3A4 inhibitors
  • Any active malignancy in the last 2 years
  • Pregnancy or lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kafrelsheikh University

Cairo, Egypt

Location

Related Publications (1)

  • Abraldes JG, Albillos A, Banares R, Turnes J, Gonzalez R, Garcia-Pagan JC, Bosch J. Simvastatin lowers portal pressure in patients with cirrhosis and portal hypertension: a randomized controlled trial. Gastroenterology. 2009 May;136(5):1651-8. doi: 10.1053/j.gastro.2009.01.043. Epub 2009 Jan 24.

    PMID: 19208350BACKGROUND

MeSH Terms

Conditions

Liver CirrhosisHypertension, Portal

Interventions

Simvastatin

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

LovastatinNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • Naira Galal, BSc in Pharmacy

    Clinical Pharmacy Department, Faculty of Pharmacy, Kafrelsheikh University

    PRINCIPAL INVESTIGATOR

  • Noha Mahmoud El-khodary, PhD

    Clinical Pharmacy Department, Faculty of Pharmacy, Kafrelsheikh University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecturer

Study Record Dates

First Submitted

March 4, 2026

First Posted

March 10, 2026

Study Start

March 15, 2024

Primary Completion

March 15, 2025

Study Completion

June 15, 2025

Last Updated

March 11, 2026

Record last verified: 2026-03

Locations

EG(1)