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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06549673




Registration number
NCT06549673
Ethics application status
Date submitted
8/08/2024
Date registered
12/08/2024
Date last updated
22/08/2025

Titles & IDs
Public title
Safety of Discontinuing NSBBs in Cirrhotic Patients With Managed Primary Aetiological Factors
Scientific title
Assessing the Safety of Discontinuing Non-selective Beta-blockers in Cirrhotic Patients With Managed Primary Aetiological Factors According to Baveno VII Consensus
Secondary ID [1] 0 0
Stop-NSBB
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Portal Hypertension 0 0
Cirrhosis 0 0
Varices, Esophageal 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 0 0 0 0
Connective tissue diseases
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Patients with cirrhosis - The patient cohort will have the primary aetiological factor of liver disease controlled, low liver stiffness measurement of below 25 kPa by vibration-controlled transient elastography, and the absence of high-risk varices on upper gastrointestinal endoscopy.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Recurrent varices
Timepoint [1] 0 0
1 year
Secondary outcome [1] 0 0
Prevalence of varices in screening cohort
Timepoint [1] 0 0
Baseline
Secondary outcome [2] 0 0
Resumption of NSBB and variceal haemorrhage
Timepoint [2] 0 0
5 years
Secondary outcome [3] 0 0
Other decompensating events
Timepoint [3] 0 0
5 years

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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)

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/01/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2031
Actual
Sample size
Target
375
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Sydney
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
China
State/province [1] 0 0
Guangzhou
Country [2] 0 0
China
State/province [2] 0 0
Shanghai
Country [3] 0 0
Hong Kong
State/province [3] 0 0
Hong Kong
Country [4] 0 0
India
State/province [4] 0 0
Hyderabad
Country [5] 0 0
India
State/province [5] 0 0
New Delhi
Country [6] 0 0
Singapore
State/province [6] 0 0
Singapore

Funding & Sponsors
Primary sponsor type
Other
Name
Chinese University of Hong Kong
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Southern Medical University, China
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Ruijin Hospital North Shanghai Jiao Tong University School of Medicine
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
National University Hospital, Singapore
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Changi General Hospital
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
Institute of Liver and Biliary Sciences, India
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
Royal Prince Alfred Hospital, Sydney, Australia
Address [6] 0 0
Country [6] 0 0
Other collaborator category [7] 0 0
Other
Name [7] 0 0
Asian Institute of Gastroenterology, India
Address [7] 0 0
Country [7] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Vincent Wong, MD
Address 0 0
Chinese University of Hong Kong
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Vincent Wong, MD
Address 0 0
Country 0 0
Phone 0 0
85235051299
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Data may be shared upon reasonable request.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
6 months after the first publication until 15 years after the end of the study
Available to whom?
By email communication
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06549673