Safety of Discontinuing NSBBs in Cirrhotic Patients With Managed Primary Aetiological Factors
Condition(s) studied
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
Primary outcome measure(s)
- Recurrent varices — 1 year
Upper endoscopy will be repeated to detect recurrent varices after stopping non-selective beta-blockers
Trial sites (8)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 |
More Chinese University of Hong Kong trials in India
Other trials for the same condition
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