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.
This multicenter, observational natural history study is designed to follow the disease trajectory of adults with cirrhosis of the liver who have a qualifying hepatic decompensation event. The primary objective of the study is to obtain real world data to understand the clinical course of cirrhotic patients following a decompensation event in order to generate data to provide context for the safety and efficacy evaluation of future interventional treatments. Observed data will be collected from the visits and assessments conducted as part of the routine standard of care (SOC) follow-up of these patients. In addition, given the variability in SOC and timing of follow-up visits across institutions, if study required assessments do not coincide with a routine SOC visit at the institution, blood draws and other study-specific assessments will be collected at defined time points for the study analysis. All participants who meet the eligibility criteria and stabilize following a hepatic decompensation event will have their clinical course followed for up to 96 weeks, and then be invited to participate in the study long term follow observational phase for a further 3 years.
Study Type
OBSERVATIONAL
Enrollment
24
Hospital Universitario Reina Sofía
Córdoba, Spain
Hospital General Universitario Gregorio Marañón
Madrid, Spain
Bristol Royal Infirmary
Bristol, United Kingdom
Examine the characteristics of patients admitted to hospital with hepatic decompensation.
Demographics
Time frame: Baseline and up to 96 weeks
Examine the characteristics of patients admitted to hospital with hepatic decompensation.
Aetiology of liver disease
Time frame: Baseline and up to 96 weeks
Examine the characteristics of patients admitted to hospital with hepatic decompensation.
Disease co-morbidities
Time frame: Baseline and up to 96 weeks
Examine the characteristics of patients admitted to hospital with hepatic decompensation.
Alcohol use
Time frame: Baseline, and up to 96 weeks
Examine the characteristics of patients admitted to hospital with hepatic decompensation.
Changes in Model for End-Stage Liver Disease (MELD) score
Time frame: Baseline, and up to 96 weeks
Examine the characteristics of patients admitted to hospital with hepatic decompensation.
Safety laboratory (biochemistry and haematology) parameters
Time frame: Baseline, and up to 96 weeks
Follow the natural history of patients admitted to hospital with hepatic decompensation.
Death or liver transplantation
Time frame: Screening up to 96 weeks
Follow the natural history of patients admitted to hospital with hepatic decompensation.
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Royal Infirmary Edinburgh
Edinburgh, United Kingdom
Leeds Teaching Hospital NHS Trust
Leeds, United Kingdom
Royal Liverpool Hospital
Liverpool, United Kingdom
King's College Hospital
London, United Kingdom
St George's Hospital
London, United Kingdom
St Mary's Hospital
London, United Kingdom
Nottingham University Hospital
Nottingham, United Kingdom
...and 2 more locations
Major hepatic decompensation events
Time frame: Screening up to 96 weeks
Follow the natural history of patients admitted to hospital with hepatic decompensation.
Hospitalisations or intensive care unit (ICU) admissions
Time frame: Screening up to 96 weeks
Follow the natural history of patients admitted to hospital with hepatic decompensation.
Changes in Model for End-Stage Liver Disease (MELD) score
Time frame: Screening up to 96 weeks
Examine the characteristics and natural history of patients with medically refractory ascites that do not require hospitalisation.
Demographics
Time frame: Screening up to 96 weeks
Examine the characteristics and natural history of patients with medically refractory ascites that do not require hospitalisation.
Safety laboratory (biochemistry and haematology) parameters
Time frame: Screening up to 96 weeks
Examine the characteristics and natural history of patients with medically refractory ascites that do not require hospitalisation.
Disease co morbidities
Time frame: Screening up to 96 weeks
Examine the characteristics and natural history of patients with medically refractory ascites that do not require hospitalisation.
Alcohol use
Time frame: Screening up to 96 weeks
Examine the characteristics and natural history of patients with medically refractory ascites that do not require hospitalisation.
Changes in MELD score
Time frame: Screening up to 96 weeks
Examine the characteristics and natural history of patients with medically refractory ascites that do not require hospitalisation.
Death or liver transplantation
Time frame: Screening up to 96 weeks
Examine the characteristics and natural history of patients with medically refractory ascites that do not require hospitalisation.
Further hepatic decompensation events
Time frame: Screening up to 96 weeks