Predicting Response and Exposure Changes in Cirrhosis for Effectiveness (NCT07750587) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Predicting Response and Exposure Changes in Cirrhosis for Effectiveness
45 participantsStarted 2026-11-01
Plain-language summary
The goal of this clinical trial is to learn how liver cirrhosis affects the way the body processes drugs in adults with different stages of liver cirrhosis. This information may help improve drug dosing for people with liver cirrhosis in the future. The main question it aims to answer is:
• How does the severity of liver cirrhosis affect the way the body processes a combination of five drugs, each used to measure the activity of a different liver enzyme?
Researchers will compare participants with mild, moderate, and severe liver cirrhosis to see whether the processing of drugs differs between these groups.
Participants will:
* Fast overnight for 8 hours before receiving the drugs
* Have a scan to measure the stiffness of their liver and spleen
* Receive a single low dose of five drugs: caffeine, warfarin, esomeprazole, metoprolol, and midazolam
* Have blood samples taken before and at several times up to 72 hours after receiving the drugs, including samples for genetic testing and blood clotting checks
* Avoid caffeine-containing food and drinks from 48 hours before receiving the drugs until the final blood sample
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥ 18 years
* Clinical, radiological and/or histological diagnosis of cirrhosis
* Informed consent signed prior to participation in the study
Exclusion Criteria:
* Original MELD score \> 30
* Estimated creatinine clearance \< 30 mL/min, calculated by using the Cockcroft-Gault equation
* Known poor metaboliser status for one of the CYP enzymes (CYP1A2, CYP2C9, CYP2C19, CYP2D6, and CYP3A) described in the medical record
* Previous clinically relevant adverse reaction or intolerance to one of the drugs in the probe drug cocktail
* Recent exposure to one of the drugs in the drug probe cocktail within five elimination half-lives prior to drug administration (corresponding to approximately 1-10 days depending on the probe drug)36-40:
* caffeine: 5h x 5 = 25 hours
* warfarin: 50h x 5 = 250 hours
* esomeprazole: 1.3h x 5 = 6.5 hours
* metoprolol: 3.5h x 5 = 17.5 hours
* midazolam: 2.5h x 5 = 12.5 hours
* Absolute contraindication for one of the drugs in the probe drug cocktail36-40:
* caffeine: drug hypersensitivity
* warfarin: drug hypersensitivity and active bleeding
* esomeprazole: drug hypersensitivity, congenital long QT syndrome and suspected gastrointestinal malignancy
* metoprolol: drug hypersensitivity, cardiogenic shock, second- and third degree AV block, bradycardia (\< 50 beats per minute), sick sinus syndrome including SA block, symptomatic hypotension (mean arterial pressure \< 65 mmHg), metabolic acidosis and untreated ph…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Unbound clearance (CL) of each parent drug
Timeframe: 24 months
2
Total and unbound area under the plasma concentration versus time curve (AUC) of each parent drug
Timeframe: 24 months
Trial details
NCT IDNCT07750587
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)