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โ† Trials
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Safety of Discontinuing NSBBs in Cirrhotic Patients With Managed Primary Aetiological Factors

Recruitingn/aAges 18 Years - anyAllChinese University of Hong Kong
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In plain words

What the trial is, and whether it could suit you

This multicentre, prospective cohort study aims to enrol 375 patients with cirrhosis who meet the following criteria: 1. effective management or elimination of the primary aetiological factor (i.e., sustained virological response in chronic hepatitis C, complete viral suppression in chronic hepatitis B, or long-term alcohol abstinence in alcohol-related liver disease), 2. liver stiffness measurements under 25 kPa, and 3. absence of varices as confirmed by endoscopy Following the cessation of non-selective beta-blockers, patients will undergo a follow-up endoscopy at the one-year mark. The study's primary endpoint is recurrent varices in 1 year. Success will be defined as the upper bound of the 95% confidence interval for recurrent varices being \<5%. Should this criterion be met, the study will extend to predefined analyses of variceal haemorrhage and hepatic decompensation at 3-and 10

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Aged 18 years or above * Evidence of cirrhosis, based on either radiological and/or clinical features * History of varices, variceal haemorrhage or portal hypertension warranting NSBB * Removal or suppression of the primary aetiological factor (i.e., sustained virological response in chronic hepatitis C, complete hepatitis B virus DNA suppression in chronic hepatitis B, and long-term alcohol abstinence in alcohol-related liver disease) * LSM \<25 kPa * Provision of written informed consent Exclusion Criteria: * Active aetiological factors not addressed in the inclusion criteria (e.g., autoimmune or hereditary liver diseases). However, hepatic steatosis-commonly coexisting with other liver diseases-is not an exclusion criterion unless accompanied by high plasma alanine aminotransferase \>40 U/L or confirmed steatohepatitis. * Recent hepatic decompensation within the past year (total bilirubin \>50 ฮผmol/L, prothrombin time \>1.3 times the upper normal limit \[unless attributable to use of anti-coagulation\], albumin \<35 g/L, or presence of ascites, variceal haemorrhage or hepatic encephalopathy). Notably, the Baveno VI criteria used LSM \<20-25 kPa and normal platelet count \>150ร—109/L to rule out varices requiring treatment (19). However, in line with the Baveno VII consensus, which sets an LSM \<25 kPa as the threshold for considering NSBB discontinuation, thrombocytopenia is not an exclusion criterion to allow the cohort to include a wider spectrum of patients. * Current or history of hepatocellular carcinoma. * Radiological evidence of portal vein thrombosis. * History of other malignancies (unless in complete remission for \>5 years). * History of liver transplantation or liver resection. * Contraindications to undergoing endoscopy. * Other clinical indications for NSBB (e.g., cardiovascular disease, arterial hypertension)
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What it tests

  • Not listed
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Where

8 sites
Royal Prince Alfred Hospital
Sydney, Australia
Southern Medical University
Guangzhou, China
Ruijing Hospital
Shanghai, China
Prince of Wales Hospital
Hong Kong, Hong Kong
AIG Hospital
Hyderabad, India
Institute of Liver and Biliary Sciences
New Delhi, India
Changi General Hospital
Singapore, Singapore
National University Hospital, Singapore
Singapore, Singapore
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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