Study in Patients With Decompensated Liver Cirrhosis (NCT06380335) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Study in Patients With Decompensated Liver Cirrhosis
Spain, United Kingdom24 participantsStarted 2023-10-10
Plain-language summary
OPAL is a multicenter observational study, following the natural disease trajectory of participants who have permanent damage to their liver caused by scarring, sometimes also referred to as liver cirrhosis. These participants will also have recently had an acute worsening of their liver disease, which is also known as a hepatic decompensating event, which has resulted in them being admitted to hospital or required them to seek medical attention as an outpatient.
Who can participate
Age range
18 Years – 75 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
. Male or female age ≥18-75 years.
. Patient is willing and able to provide informed consent to participate in the study.
. Patient confirms willingness/ability to comply with all study procedures.
. Has a diagnosis of liver cirrhosis determined by a physician based on at least one of the following:
. clinical and radiological features that correlate with a diagnosis of cirrhosis;
. previous liver biopsy confirming histological features of cirrhosis.
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
Examine the characteristics of patients admitted to hospital with hepatic decompensation.
Timeframe: Baseline and up to 96 weeks
2
Examine the characteristics of patients admitted to hospital with hepatic decompensation.
Timeframe: Baseline and up to 96 weeks
3
Examine the characteristics of patients admitted to hospital with hepatic decompensation.
Timeframe: Baseline and up to 96 weeks
4
Examine the characteristics of patients admitted to hospital with hepatic decompensation.
Timeframe: Baseline, and up to 96 weeks
5
Examine the characteristics of patients admitted to hospital with hepatic decompensation.
Timeframe: Baseline, and up to 96 weeks
6
Examine the characteristics of patients admitted to hospital with hepatic decompensation.
. 5\. For eligibility at Screen Part 2 - Aetiology of liver disease of steatotic liver disease (SLD) including pure metabolic dysfunction associated steatotic liver disease (MASLD) or metabolic and alcohol related/associated liver disease (Met-ALD), or alcohol-related liver diseases (ALD).
Exclusion criteria
. Liver cirrhosis due to:
. any viral hepatitis , or
. autoimmune and cholestatic aetiologies including, but not limited to, primary biliary cholangitis and primary sclerosing cholangitis.
. Acute liver disease in the absence of underlying liver cirrhosis, including, but not limited to, drug induced liver injury.
. Any current organ failure requiring more than out-patient non-invasive supportive care, and not associated with the patient's qualifying hepatic decompensation event.
. Known splenomegaly ≥16cm.
. Thrombocytopenia \<50,000 mm3.
. Sepsis (with positive microbial cultures) or as defined by the Investigator, unless stable and is at least 4 weeks after having completed a full course of intravenous antibiotics.