NCT07459972CompletedPhase 4
Clinical Evaluation of Simcyp-Guided Simvastatin Dosing in Patients With Liver Cirrhosis
Dose Prediction for Statins and Anticoagulant Medications in Cirrhotic Patients Using Simcyp Program: Applications in Clinical Practice
Source: ClinicalTrials.gov · Last updated 11 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 22 (actual)
- First submitted
- 4 Mar 2026
- Start date
- 15 Mar 2024
- Primary completion date
- 15 Mar 2025
- Lead sponsor
- Kafrelsheikh University
- Diseases
- High blood pressure
- NCT number
- NCT07459972
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 22
- From 15 Mar 2024 to the primary completion date, 15 Mar 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current therapy with strong CYP3A4 inhibitors
Other illness
- Known hypersensitivity to simvastatin
- Any active malignancy in the last 2 years
Lab values
- Severe renal impairment (eGFR \< 30 mL/min/1.73 m²)
Other
- Active hepatocellular carcinoma
- Baseline creatine kinase (CK) \> 3 × upper limit of normal
- Pregnancy or lactation
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Kafrelsheikh University Coordinator of this site? Confirm its status | Cairo | Egypt | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.