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

NCT06549673 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 375

Last updated 2025-08-22

No results posted yet for this 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.

Conditions

  • Portal Hypertension
  • Cirrhosis
  • Varices, Esophageal

Sponsors & Collaborators

  • Southern Medical University, China

    collaborator OTHER

  • Ruijin Hospital North Shanghai Jiao Tong University School of Medicine

    collaborator UNKNOWN

  • National University Hospital, Singapore

    collaborator OTHER

  • Changi General Hospital

    collaborator OTHER

  • Institute of Liver and Biliary Sciences, India

    collaborator OTHER

  • Royal Prince Alfred Hospital, Sydney, Australia

    collaborator OTHER

  • Asian Institute of Gastroenterology, India

    collaborator OTHER

  • Chinese University of Hong Kong

    lead OTHER

Principal Investigators

  • Vincent Wong, MD · Chinese University of Hong Kong

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-20
Primary Completion
2027-12-31
Completion
2031-12-31

Countries

  • Australia
  • China
  • Hong Kong
  • India
  • Singapore

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06549673 on ClinicalTrials.gov