MEASURER

The effect of liver cirrhosis on the pharmacokinetics, effectiveness and safety of three frequently used drugs in patients with chronic liver disease - Pharmacokinetics, effectiveness and safety of three frequently used drugs in patients with liver cirrhosis

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON58294

Enrollment

100

Registered

2025-04-29

Start date

2026-02-11

Completion date

Unknown

Last updated

2026-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cirrhosis Chronic liver disease

Interventions

We are not investigating a specific product or intervention. We are examining applied and approved medications in the setting of liver cirrhosis. Additional interventions such as HVPG measurements are

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Persons that are Diagnosed with liver cirrhosis (Child-Pugh A, B or C) based on ultrasound, transient elastography or clinical parametersAge = 18 yearsUsing or started on carvedilol, spironolactone and or metformin after being diagnosed with cirrhosisPatients capable of understanding the purpose of this study, has been fully informed and has given written informed consent to participate in this study

Exclusion criteria

Exclusion criteria: Persons that haveSystemic infection (since this interferes with metabolic capacity of the liver) Presence of transjugular intrahepatic portosystemic shunt (TIPS)Patients receiving dialysesPregnancy or breast feedingRecent (< 1 months) gastrointestinal bleedingPatients with bariatric surgery in medical historyFor HVPG measurements: patients using anticoagulation For HVPG measurements: patients with a thrombocyte level < 50 x 10^9/LFor HVPG measurements: patients with a known allergy to intravenous contrast media

Design outcomes

Primary

Measure	Time frame
Primary study parameters/endpoints: Pharmacokinetic parameters (AUC0-24, Cmax, Cmin, Tmax, T1/2, Vd, % protein binding, Cl) of the drugs of interest.	—

Secondary

Measure	Time frame
Secondary study parameters: Relevant covariates i.e. causes of cirrhosis, age, sex, kidney function and pharmacogenetics Number of episodes of hepatic encephalopathy, gastrointestinal bleedings or number of and amount of fluid during ascites drainages within one year prior to blood sampling, and occurring after the diagnosis of cirrhosis Drug prescriptions during the year prior to blood sampling Vital functions and MELD scores HPVG measurements for patients using carvedilol Weight differences while on spironolactone during one year prior to blood sampling HbA1C and blood glucose levels for patients using metformin	—

Measure

Time frame

Secondary study parameters: Relevant covariates i.e. causes of cirrhosis, age, sex, kidney function and pharmacogenetics Number of episodes of hepatic encephalopathy, gastrointestinal bleedings or number of and amount of fluid during ascites drainages within one year prior to blood sampling, and occurring after the diagnosis of cirrhosis Drug prescriptions during the year prior to blood sampling Vital functions and MELD scores HPVG measurements for patients using carvedilol Weight differences while on spironolactone during one year prior to blood sampling HbA1C and blood glucose levels for patients using metformin

—

Countries

Netherlands

Contacts

Public ContactM B Mulder

Erasmus MC, Universitair Medisch Centrum Rotterdam

midas.mulder@haaglandenmc.nl088 979 7900

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Apr 3, 2026