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Clinical Trials in India / NCT06549673
Recruiting

Safety of Discontinuing NSBBs in Cirrhotic Patients With Managed Primary Aetiological Factors

NCT06549673 · tracked via the Priya Life Science India tracker
Sponsor
Chinese University of Hong Kong
Phase
Started
2025-01-20
Last updated
2025-08-22

Condition(s) studied

Portal HypertensionCirrhosisVarices, Esophageal

Study summary

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-year intervals (funded through local resources; the General Research Fund will cover patient recruitment costs for 1 year). Clinical assessments, laboratory tests, liver and spleen stiffness measurements will be performed at baseline, 3 months, 6 months and 12 months to identify potential predictors of variceal recurrence and assess the feasibility of early identification.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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)

Primary outcome measure(s)

Trial sites (8)

FacilityCityRegionStatus
Royal Prince Alfred Hospital Sydney Australia Not Yet Recruiting
Southern Medical University Guangzhou China Not Yet Recruiting
Ruijing Hospital Shanghai China Not Yet Recruiting
Prince of Wales Hospital Hong Kong Hong Kong Recruiting
AIG Hospital Hyderabad India Not Yet Recruiting
Institute of Liver and Biliary Sciences New Delhi India Not Yet Recruiting
Changi General Hospital Singapore Singapore Not Yet Recruiting
National University Hospital, Singapore Singapore Singapore Not Yet Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06549673 on ClinicalTrials.gov ↗ ← All trials in India