protocolSection identificationModule nctId: NCT06380335, orgStudyIdInfo id: RTX001-01S, briefTitle: Study in Patients With Decompensated Liver Cirrhosis, acronym: OPAL, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-10, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2026-11-03, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: Resolution Therapeutics Limited, class: NETWORK, descriptionModule briefSummary: 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., conditionsModule conditions: Liver Cirrhosis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 240, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Examine the characteristics of patients admitted to hospital with hepatic decompensation., primaryOutcomes measure: Examine the characteristics of patients admitted to hospital with hepatic decompensation., primaryOutcomes measure: Examine the characteristics of patients admitted to hospital with hepatic decompensation., primaryOutcomes measure: Examine the characteristics of patients admitted to hospital with hepatic decompensation., primaryOutcomes measure: Examine the characteristics of patients admitted to hospital with hepatic decompensation., primaryOutcomes measure: Examine the characteristics of patients admitted to hospital with hepatic decompensation., secondaryOutcomes measure: Follow the natural history of patients admitted to hospital with hepatic decompensation., secondaryOutcomes measure: Follow the natural history of patients admitted to hospital with hepatic decompensation., secondaryOutcomes measure: Follow the natural history of patients admitted to hospital with hepatic decompensation., secondaryOutcomes measure: Follow the natural history of patients admitted to hospital with hepatic decompensation., secondaryOutcomes measure: Examine the characteristics and natural history of patients with medically refractory ascites that do not require hospitalisation., secondaryOutcomes measure: Examine the characteristics and natural history of patients with medically refractory ascites that do not require hospitalisation., secondaryOutcomes measure: Examine the characteristics and natural history of patients with medically refractory ascites that do not require hospitalisation., secondaryOutcomes measure: Examine the characteristics and natural history of patients with medically refractory ascites that do not require hospitalisation., secondaryOutcomes measure: Examine the characteristics and natural history of patients with medically refractory ascites that do not require hospitalisation., secondaryOutcomes measure: Examine the characteristics and natural history of patients with medically refractory ascites that do not require hospitalisation., secondaryOutcomes measure: Examine the characteristics and natural history of patients with medically refractory ascites that do not require hospitalisation., otherOutcomes measure: Explore clinical and laboratory parameters., otherOutcomes measure: Evaluate the effect of disease progression on biomarkers of inflammatory activity, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Bristol Royal Infirmary, status: RECRUITING, city: Bristol, zip: BS2 8HW, country: United Kingdom, geoPoint lat: 51.45523, lon: -2.59665, locations facility: Royal Infirmary Edinburgh, status: RECRUITING, city: Edinburgh, zip: EH16 4SA, country: United Kingdom, geoPoint lat: 55.95206, lon: -3.19648, locations facility: Royal Liverpool Hospital, status: RECRUITING, city: Liverpool, zip: L7 8XP, country: United Kingdom, geoPoint lat: 53.41058, lon: -2.97794, locations facility: Royal Free Hospital, status: RECRUITING, city: London, zip: NW3 2QG, country: United Kingdom, geoPoint lat: 51.50853, lon: -0.12574, locations facility: King's College Hospital, status: RECRUITING, city: London, zip: SE5 9RS, country: United Kingdom, geoPoint lat: 51.50853, lon: -0.12574, locations facility: St George's Hospital, status: RECRUITING, city: London, zip: SW17 0QT, country: United Kingdom, geoPoint lat: 51.50853, lon: -0.12574, locations facility: St Mary's Hospital, status: RECRUITING, city: London, zip: W2 1NY, country: United Kingdom, geoPoint lat: 51.50853, lon: -0.12574, locations facility: Nottingham University Hospital, status: RECRUITING, city: Nottingham, zip: NG5 1PB, country: United Kingdom, geoPoint lat: 52.9536, lon: -1.15047, locations facility: Sunderland Royal Hospital, status: RECRUITING, city: Sunderland, zip: SR4 7TP, country: United Kingdom, geoPoint lat: 54.90465, lon: -1.38222, hasResults: False