Stopping non-selective beta-blockers in people with cirrhosis whose main cause is controlled

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicentre prospective cohort enrolling about 375 patients with cirrhosis who have effective control or elimination of the primary cause (for example, cured hepatitis C, suppressed hepatitis B, or long-term alcohol abstinence), liver stiffness below 25 kPa, and no varices on endoscopy. Enrolled patients will stop non-selective beta-blockers and undergo a follow-up endoscopy at one year to detect recurrent varices. The primary endpoint is recurrent varices at one year with success defined as the upper bound of the 95% confidence interval for recurrence being less than 5%. If that threshold is met, predefined analyses of variceal bleeding and hepatic decompensation at 3 and 10 years will be pursued using local funding.

Why it matters

Who can join: the full rules

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 μmol/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 \>150×109/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)

Where it's running

• Prince of Wales Hospital
  Hong Kong, Hong Kong Recruiting
• Royal Prince Alfred Hospital
  Sydney, Australia Not yet recruiting
• Southern Medical University
  Guangzhou, China Not yet recruiting
• Ruijing Hospital
  Shanghai, China Not yet recruiting
• AIG Hospital
  Hyderabad, India Not yet recruiting
• Institute of Liver and Biliary Sciences
  New Delhi, India Not yet recruiting

Study contacts

• Principal investigator: Vincent Wong, MD — Chinese University of Hong Kong
• Study coordinator: Vincent Wong, MD
• Email: wongv@cuhk.edu.hk
• Phone: 85235051299

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.