AzTrials
AzTrials

Liver CirrhosisPhase 4NCT07397481

Clinical Application of Simcyp-Guided Doses of Antihypertensive Drugs in Cirrhotic Patients

A Phase 4 study testing Nebivolol 5 mg, Carvedilol 12.5 mg and Nebivolol 2.5 mg in people with Liver Cirrhosis and Arterial Hypertension, run by Kafrelsheikh University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This was a prospective, open-label, randomized, parallel pilot clinical study conducted over 3 months on 50 Egyptian cirrhotic patients with arterial hypertension and portal hypertension, evaluating the real-world applicability of selected PBPK-guided dosing regimens. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Liver Cirrhosis, Arterial Hypertension
What is being tested?
Nebivolol 5 mg, Carvedilol 12.5 mg and Nebivolol 2.5 mg
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteEgypt
Study dates
1 Mar 2024to 1 Jun 2025
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age of patients > 18 years.
  • Diagnosed with cirrhosis
  • Have cardiovascular disease(Hypertension )
  • Presence of portal hypertension
  • No history of variceal bleeding

Who cannot join

  • Patients with kidney disorder or dialysis
  • Hypersensitivity to study medications
  • Active cancer history in the last 2 years
  • Taking drugs that interact with antihypertensive drugs in the last two weeks
  • Pregnancy

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Kafrelsheikh University

    Cairo, Egypt

Other trials in Egypt

About this study

Official title: Dose Prediction for Antihypertensive Medications in Cirrhotic Patients Using Simcyp Program: Applications in Clinical Practice

This was a prospective, open-label, randomized, parallel pilot clinical study conducted over 3 months on 50 Egyptian cirrhotic patients with arterial hypertension and portal hypertension, evaluating the real-world applicability of selected PBPK-guided dosing regimens. Patients were stratified according to Child-Pugh class (CP-A or CP-B) and randomly assigned to receive either nebivolol or carvedilol at doses corresponding to the closest commercially available strengths to Simcyp®-predicted doses.

Clinical evaluation included serial blood pressure measurements, comprising systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), and heart rate (HR). Doppler ultrasonographical assessment was performed to evaluate portal and hepatic hemodynamics, including portal vein diameter, portal vein velocity, congestion index, hepatic artery resistive index, and modified vascular liver index. Routine laboratory investigations were conducted to assess efficacy and safety and included liver function tests (serum albumin, total bilirubin, alanine aminotransferase [ALT], and aspartate aminotransferase [AST]), kidney function tests (serum creatinine and blood urea nitrogen [BUN]), and fasting blood glucose. Patients were followed on a monthly basis, with systematic documentation of adverse events throughout the study period.

Read the detailed description

This was a prospective, randomized, parallel, open-label pilot clinical study conducted over three months on Egyptian cirrhotic patients with arterial hypertension and portal hypertension. Adult patients aged >18 years with confirmed liver cirrhosis, concomitant arterial hypertension, and portal hypertension without a history of variceal bleeding were eligible for inclusion. Patients with renal disorders or on dialysis, pregnancy, known hypersensitivity to the study medications, active malignancy within the previous two years, or recent use of drugs interacting with antihypertensive agents were excluded. Patients were stratified according to Child-Pugh (CP) classification into CP class A and CP class B and randomly allocated into four treatment groups to receive either nebivolol or carvedilol at doses corresponding to the closest commercially available strengths to Simcyp®-predicted doses. CP class A patients were assigned to Group A (nebivolol 5 mg once daily) or Group B (carvedilol 12.5 mg once daily), while CP class B patients were assigned to Group C (nebivolol 2.5 mg once daily) or Group D (carvedilol 6.25 mg once daily). Clinical evaluation included serial blood pressure measurements, comprising systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), and heart rate (HR), which were assessed at baseline and after 2, 4, 8, and 12 weeks of treatment. Doppler ultrasonographical assessment was performed to evaluate portal and hepatic hemodynamics, including portal vein diameter, portal vein velocity, congestion index, hepatic artery resistive index, and modified vascular liver index. Routine laboratory investigations were conducted to assess efficacy and safety and included liver function tests (serum albumin, total bilirubin, alanine aminotransferase [ALT], and aspartate aminotransferase [AST]), kidney function tests (serum creatinine and blood urea nitrogen [BUN]), CBC and fasting blood glucose. Patients were followed monthly throughout the study period, with systematic documentation of adverse events. During the study, four patients from CP class A discontinued participation and were excluded from the final analysis.

Being tested
Nebivolol 5 mg, Carvedilol 12.5 mg, Nebivolol 2.5 mg, Carvedilol 6.25 mg
Keywords
Liver Cirrhosis, Anti- Hypertensive Drugs, Portal Hypertension
Medical subject headings
Liver Cirrhosis, Hypertension, Hypertension, Portal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nebivolol 5 mgDrug

    Also called Nevilob 5mg

    Nebivolol is a third-generation cardio-selective β-1 adrenergic blocker with nitric oxide-mediated vasodilatory properties and it is primarily used to treat hypertension . Nebivolol reduces intrahepatic vascular resistance by enhancing nitric oxide (NO) production within the hepatic endothelium, thereby lowering portal pressure.

  • Carvedilol 12.5 mgDrug

    Also called Carvipress 12.5 mg

    Carvedilol is used to treat hypertension and it lowers blood pressure effectively through a combination of β adrenergic blockade and α-1-mediated vasodilation. Carvedilol lowers portal pressure by β1-mediated reduction of cardiac output, β2-mediated splanchnic vasoconstriction, and additional α1-adrenergic blockade, which induces intrahepatic vasodilation, thereby reducing portal hypertension.

  • Nebivolol 2.5 mgDrug

    Also called Nevilob 2.5mg

    Nebivolol is a third-generation cardio-selective β-1 adrenergic blocker with nitric oxide-mediated vasodilatory properties and it is primarily used to treat hypertension . Nebivolol reduces intrahepatic vascular resistance by enhancing nitric oxide (NO) production within the hepatic endothelium, thereby lowering portal pressure.

  • Carvedilol 6.25 mgDrug

    Also called Carvipress 6.25 mg

    Carvedilol is used to treat hypertension and it lowers blood pressure effectively through a combination of β adrenergic blockade and α-1-mediated vasodilation. Carvedilol lowers portal pressure by β1-mediated reduction of cardiac output, β2-mediated splanchnic vasoconstriction, and additional α1-adrenergic blockade, which induces intrahepatic vasodilation, thereby reducing portal hypertension.

Study groups in NCT07397481
Study groupRoleWhat they receive
• Group A (n = 10): Child-Pugh class A patients received nebivolol at a dose of 5 mg once daily.Active comparatorNebivolol at a dose of 5 mg (Nevilob 5 mg®, Marcyrl Pharmaceutical Industries, Egypt)
Receives: Drug: Nebivolol 5 mg
• Group B (n = 10): Child-Pugh class A patients received carvedilol at a dose of 12.5 mg once daily.Active comparatorCarvedilol at a dose of 12.5 mg (Carvipress 12.5 mg®, Global Napi Pharmaceuticals, Egypt)
Receives: Drug: Carvedilol 12.5 mg
Group C (n = 10): Child-Pugh B patients received nebivolol 2.5 mg once dailyActive comparatorNebivolol at a dose of 2.5 mg (Nevilob 2.5 mg®, Marcyrl Pharmaceutical Industries, Egypt)
Receives: Drug: Nebivolol 2.5 mg
Group D (n = 10): Child-Pugh B patients received carvedilol 6.25 mg once dailyActive comparatorCarvedilol at a dose of 6.25 mg (Carvipress 6.25 mg®, Global Napi Pharmaceuticals, Egypt)
Receives: Drug: Carvedilol 6.25 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Management of arterial hypertension

    by measuring Systolic and diastolic blood pressure (mmHg)

    Measured: 3 month

Secondary outcomes (1)

  1. Adverse Effects Monitoring

    Adverse effects including headache, gastrointestinal disorders, weakness, shortness of breath, and hyperglycemia will be recorded.

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Feb 2026
  2. Study start1 Mar 2024
  3. Primary completion1 Mar 2025
  4. Study completion1 Jun 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07397481
Sponsor's protocol ID
KFSIRB200-126
Status last verified
Feb 2026
First submitted
20 Jan 2026
Last updated
9 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Li T, Ke W, Sun P, Chen X, Belgaumkar A, Huang Y, Xian W, Li J, Zheng Q. Carvedilol for portal hypertension in cirrhosis: systematic review with meta-analysis. BMJ Open. 2016 May 4;6(5):e010902. doi: 10.1136/bmjopen-2015-010902.

    PubMed 27147389

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Nebivolol 5 mg, Carvedilol 12.5 mg and Nebivolol 2.5 mg in people with Liver Cirrhosis and Arterial Hypertension, run by Kafrelsheikh University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Management of arterial hypertension (time frame: 3 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07397481, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in