Actively Recruiting
Safety of Discontinuing NSBBs in Cirrhotic Patients With Managed Primary Aetiological Factors
Led by Chinese University of Hong Kong · Updated on 2025-08-22
375
Participants Needed
8
Research Sites
362 weeks
Total Duration
On this page
Sponsors
C
Chinese University of Hong Kong
Lead Sponsor
S
Southern Medical University, China
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Safety of Discontinuing NSBBs in Cirrhotic Patients With Managed Primary Aetiological Factors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 years or above
- Evidence of cirrhosis based on radiological or clinical features
- History of varices, variceal bleeding, or portal hypertension requiring NSBB treatment
- Primary liver disease cause controlled or eliminated (e.g., sustained viral suppression or long-term abstinence from alcohol)
- Liver stiffness measurement below 25 kPa
- Provided written informed consent
You will not qualify if you...
- Active liver diseases not controlled by inclusion criteria such as autoimmune or hereditary liver diseases
- Recent liver decompensation within the past year, including high bilirubin, abnormal prothrombin time, low albumin, or presence of ascites, variceal bleeding, or hepatic encephalopathy
- Current or past hepatocellular carcinoma
- Portal vein thrombosis seen on imaging
- History of other cancers unless in remission for over 5 years
- History of liver transplant or liver surgery
- Unable to undergo endoscopy
- Other reasons for NSBB use such as cardiovascular disease or high blood pressure
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
Royal Prince Alfred Hospital
Sydney, Australia
Not Yet Recruiting
2
Southern Medical University
Guangzhou, China
Not Yet Recruiting
3
Ruijing Hospital
Shanghai, China
Not Yet Recruiting
4
Prince of Wales Hospital
Hong Kong, Hong Kong
Actively Recruiting
5
AIG Hospital
Hyderabad, India
Not Yet Recruiting
6
Institute of Liver and Biliary Sciences
New Delhi, India
Not Yet Recruiting
7
Changi General Hospital
Singapore, Singapore
Not Yet Recruiting
8
National University Hospital, Singapore
Singapore, Singapore
Not Yet Recruiting
Research Team
V
Vincent Wong, MD
CONTACT
A
Angel Chim, MSc
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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