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 range18 Years – 75 Years
SexALL
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.
✓. 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.
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.
✕. 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.