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RECRUITING
NCT06549673

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

Sponsor: Chinese University of Hong Kong

View on ClinicalTrials.gov

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.

Official title: Assessing the Safety of Discontinuing Non-selective Beta-blockers in Cirrhotic Patients With Managed Primary Aetiological Factors According to Baveno VII Consensus

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

375

Start Date

2025-01-20

Completion Date

2031-12-31

Last Updated

2025-08-22

Healthy Volunteers

Not specified

Locations (8)

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