NCT06549673Recruiting
Safety of Discontinuing NSBBs in Cirrhotic Patients With Managed Primary Aetiological Factors
Assessing the Safety of Discontinuing Non-selective Beta-blockers in Cirrhotic Patients With Managed Primary Aetiological Factors According to Baveno VII Consensus
Source: ClinicalTrials.gov · Last updated 22 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 375 (estimated)
- First submitted
- 8 Aug 2024
- Start date
- 20 Jan 2025
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Chinese University of Hong Kong
- Diseases
- High blood pressure
- NCT number
- NCT06549673
What you commit to
- Study type: Observational
- Planned participants: 375
- From 20 Jan 2025 to the primary completion date, 31 Dec 2027
- 8 sites in 5 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
- Current or history of hepatocellular carcinoma.
- Radiological evidence of portal vein thrombosis.
- History of liver transplantation or liver resection.
- Other clinical indications for NSBB (e.g., cardiovascular disease, arterial hypertension)
Lab values
- 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.
Age
- History of other malignancies (unless in complete remission for \>5 years).
Other
- Contraindications to undergoing endoscopy.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Royal Prince Alfred Hospital Coordinator of this site? Confirm its status | Sydney | Australia | Not yet recruiting |
| Southern Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Not yet recruiting |
| Ruijing Hospital Coordinator of this site? Confirm its status | Shanghai | China | Not yet recruiting |
| Prince of Wales Hospital Coordinator of this site? Confirm its status | Hong Kong | Hong Kong SAR China | Recruiting |
| Aig Hospital Coordinator of this site? Confirm its status | Hyderabad | India | Not yet recruiting |
| Institute of Liver and Biliary Sciences Coordinator of this site? Confirm its status | New Delhi | India | Not yet recruiting |
| National University Hospital Singapore Coordinator of this site? Confirm its status | Singapore | Singapore | Not yet recruiting |
| Changi General Hospital Coordinator of this site? Confirm its status | Singapore | Singapore | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.