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Portal HypertensionNCT06549673

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

An observational study of Portal Hypertension and Cirrhosis, run by Chinese University of Hong Kong at 8 sites in 5 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
How many people
375 participants
Where
8 sitesin 5 countries
Study dates
20 Jan 2025to 31 Dec 2031
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Adult, Older adult

Study population: Eligible patients will be identified from the general medical and hepatology clinics in Hong Kong and collaborating countries.

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

8 sites in 5 countries. Contact the study team or a site near you to ask about taking part.

Vincent Wong, MD contact

85235051299

wongv@cuhk.edu.hk

Angel Chim, MSc contact

85235054205

angelchim@cuhk.edu.hk

8 sites in 5 countries

China2 sites, 2 recruiting
  • Southern Medical University

    Guangzhou

    Jinjun Chen, PhD, 86-2061648047, chjj@smu.edu.cn

    Not yet recruiting
  • Ruijing Hospital

    Shanghai

    Qing Xie, PhD, 86-2164370045, xieqingrjh@163.com

    Not yet recruiting

Other trials in China

India2 sites, 2 recruiting
  • AIG Hospital

    Hyderabad

    Anand Kulkarni, MD, 91-4042444222, anandvk90@gmail.com

    Not yet recruiting
  • Institute of Liver and Biliary Sciences

    New Delhi

    Ashok Choudhury, MD, 11-46300000, doctor.ashokchoudhury@gmail.com

    Not yet recruiting

Other trials in India

Singapore2 sites, 2 recruiting
  • Changi General Hospital

    Singapore

    Yu Jun Wong, MD, 65-67888833, wongyujun1985@gmail.com

    Not yet recruiting
  • National University Hospital, Singapore

    Singapore

    Mark Muthiah, MD, 65-69082222, mdcmdm@nus.edu.sg

    Not yet recruiting

Other trials in Singapore

Australia1 site, 1 recruiting
  • Royal Prince Alfred Hospital

    Sydney

    Ken Liu, PhD, 61-295156111, Ken.Liu@health.nsw.gov.au

    Not yet recruiting

Other trials in Australia

Hong Kong1 site, 1 recruiting
  • Prince of Wales Hospital

    Hong Kong

    Vincent WS Wong, MD

    Recruiting

Other trials in Hong Kong

About this study

Official title: Assessing the Safety of Discontinuing Non-selective Beta-blockers in Cirrhotic Patients With Managed Primary Aetiological Factors According to Baveno VII Consensus

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.

Read the detailed description

1.1 Significance of cirrhosis and portal hypertension

Liver cirrhosis is the common final pathway of various chronic liver diseases. Globally, mortality due to cirrhosis have risen from 899 000 in 1990 to 1.32 million deaths in 2017. Additionally, as of 2017, 112 million and 10.6 million people were living with compensated and decompensated cirrhosis, respectively. Portal hypertension stands out as the primary cause of cirrhotic complications, such as ascites and variceal haemorrhage. Accurate diagnosis of clinically significant portal hypertension is crucial because the administration of non-selective beta-blockers (NSBBs) can reduce the risk of variceal haemorrhage and hepatic decompensation.

Chronic liver disease is highly prevalent in Hong Kong. A community screening study in Hong Kong in 2015-2016 indicated that the prevalence of hepatitis B surface antigen was still 7.8%. Studies by our group have further highlighted the extent of the problem, revealing that 26% of the local population and a staggering 73% of patients with type 2 diabetes suffer from metabolic dysfunction-associated steatotic liver disease. These chronic liver diseases carry a significant risk of progressing to cirrhosis and hepatic decompensation.

1.2 Non-invasive assessment of portal hypertension

Historically, the gold standard for assessing portal hypertension requires the measurement of hepatic venous pressure gradient, an invasive procedure rarely performed outside research settings. However, accumulating data support the use of non-invasive tests to assess portal hypertension. Specifically, liver stiffness measurement (LSM) through vibration-controlled transient elastography reflects the degree of liver fibrosis and the severity of cirrhosis. Furthermore, the platelet count reflects whether a patient with cirrhosis has hypersplenism secondary to portal hypertension. Additionally, spleen stiffness measurement (SSM) may be an even more direct evaluation of portal hypertension and has been used to ascertain improvements in portal hypertension following the initiation of NSBB. Based on existing data, the latest Baveno VII consensus has endorsed the use of these non-invasive tests to rule out (if LSM <15 kPa and platelet count >150×10e9/L) and to confirm (if LSM ≥25 kPa) the presence of clinically significant portal hypertension.

In a randomised controlled trial involving 548 patients with radiological cirrhosis, our group demonstrated that LSM+SSM was non-inferior to routine endoscopy in detecting varices and preventing future variceal haemorrhage. Furthermore, we validated the use of LSM-based criteria for excluding the presence of varices requiring treatment across a range of chronic liver diseases, including patients with or without hepatocellular carcinoma. Additionally, we reported the natural history of patients falling within the grey zone according to the Baveno VII criteria. Importantly, we identified factors associated with hepatic decompensation in this specific patient population.

1.3 Emerging concept: hepatic recompensation and reversal of cirrhosis and portal hypertension

As a number of chronic liver diseases can now be well controlled or cured, it is increasingly apparent that cirrhosis can resolve over time when the primary aetiology is controlled. Reports have also emerged, suggesting an improvement in portal hypertension and even hepatic recompensation in such circumstances. This has led to the practical recommendation on discontinuing NSBB in patients with LSM <25 kPa after removal or suppression of the primary aetiological factor, in the absence of varices. Removal or suppression of the primary aetiological factor includes sustained virological response in chronic hepatitis C, complete hepatitis B virus DNA suppression in chronic hepatitis B patients, and long-term abstinence from alcohol in those with alcohol-related liver disease. Nonetheless, it is crucial to note that these recommendations are based on tenuous evidence (C.2 recommendation). While cessation of NSBB in patients no longer requiring it can reduce unnecessary expenses (prescription and monitoring) and side effects, it remains imperative to confirm the safety of this approach through well-designed, prospective studies.

Keywords
Portal hypertension, Cirrhosis, Esophageal varices, Gastric varices
Medical subject headings
Hypertension, Portal, Fibrosis, Esophageal and Gastric Varices

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06549673
Study groupRoleWhat they receive
Patients with cirrhosisThe 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recurrent varices

    Upper endoscopy will be repeated to detect recurrent varices after stopping non-selective beta-blockers

    Measured: 1 year

Secondary outcomes (3)
  1. Prevalence of varices in screening cohort

    In the initial screening cohort of all patients who undergo endoscopy, we will calculate the proportion and 95% CI of patients with LSM <25 kPa who still harbour varices at baseline despite NSBB treatment and removal or suppression of the primary aetiological factor.

    Measured: Baseline

  2. Resumption of NSBB and variceal haemorrhage

    For patients discontinuing NSBB, the secondary endpoint is resumption of NSBB or variceal haemorrhage during follow-up.

    Measured: 5 years

  3. Other decompensating events

    Other decompensating events include ascites and hepatic encephalopathy post-NSBB cessation, and the statistical methods used will be similar to those for variceal haemorrhage.

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Aug 2024
  2. Study start20 Jan 2025
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
375 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06549673
Sponsor's protocol ID
Stop-NSBB
Status last verified
Aug 2025
First submitted
8 Aug 2024
Last updated
22 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Data may be shared upon reasonable request.

Questions about this trial

What is this clinical trial studying?

An observational study of Portal Hypertension and Cirrhosis, run by Chinese University of Hong Kong at 8 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in China, India, Singapore, Australia, Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Vincent Wong, MD (85235051299, wongv@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recurrent varices (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025.

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