NCT06449339 Non-selective Beta-blocker in Compensated Advanced Chronic Liver Disease
| NCT ID | NCT06449339 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Chinese University of Hong Kong |
| Condition | Portal Hypertension |
| Study Type | INTERVENTIONAL |
| Enrollment | 474 participants |
| Start Date | 2024-07-17 |
| Primary Completion | 2031-07-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 474 participants in total. It began in 2024-07-17 with a primary completion date of 2031-07-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this randomised controlled trial is to evaluate the effect of carvedilol (a non-selective beta-blocker) in patients with compensated advanced chronic liver disease under clinically significant portal hypertension or the grey zone of Baveno VII criteria. The main question it aims to answer is: Does carvedilol reduce hepatic decompensation and mortality in these patients despite the absence of varices needing treatment. Researchers will compare carvedilol to no carvedilol to see if carvedilol can prevent hepatic decompensation and mortality. Participants will either take carvedilol or not taking carvedilol for 5 years with regular clinic visit for checkups and investigations, including blood tests, ultrasonography of the liver, upper gastrointestinal endoscopy, transient elastography.
Eligibility Criteria
Inclusion Criteria: * Aged 18 years of above * Established diagnosis of chronic liver disease(s) of the following etiologies * Alcohol-related liver disease (ARLD) * Chronic hepatitis B (CHB) * Chronic hepatitis C (CHC) * Metabolic dysfunction-associated steatotic liver disease (MASLD) § Non-obese (BMI \<30kg/m2) and obese (BMI ≥30 kg/m2) * In high-risk grey zone or CSPH, by Baveno VII criteria (for ARLD, CHB, CHC and non-obese MASLD) or ANTICIPATE-NASH model (for obese MASLD) within 6 months from screening * Baveno VII criteria (for ARLD, CHB, CHC and non-obese MASLD) * LSM ≥25 kPa (CSPH) * LSM ≥20 kPa - \<25 kPa and platelet count \<150 x 10\^9/L; or LSM ≥15 kPa - \<20 kPa and platelet count \<110 x 10\^9/L (high-risk grey zone) * ANTICIPATE-NASH model (for obese MASLD) * Predictive probability for CSPH \>90% (CSPH) * Predictive probability for CSPH ≥60% - \<90% (high-risk grey zone) Exclusion Criteria: * Presence of high-risk varices (HRV) (i.e. moderate to large oesophageal varices \[OV\] or OV with red wale sign) found in OGD * Current use of non-selective beta-blocker (NSBB) or any use of NSBB within 6 months before * Use of selective beta blocker, such as atenolol or metoprolol, is not excluded * Selective beta-blocker will be switched to carvedilol in NSBB arm, and will be kept unchanged in conventional arm if there is clinical need for the selective beta-blocker * Contraindication to NSBB (e.g. Type II/III heart block or baseline bradycardia \<60/minute, hypotension with systolic blood pressure (SBP) \<100 mmHg, asthma, poorly controlled chronic obstructive pulmonary disease, and peripheral vascular disease) * Current use of nitrated drugs or any use of nitrated drugs within 6 months before o Use of sublingual nitrate, such as glyceryl trinitrate, is not excluded * Contraindication to OGD (e.g. Intestinal perforation or obstruction) * Current or history of decompensated liver cirrhosis (i.e. Child's C cirrhosis, prior decompensating events such as ascites, variceal bleeding, hepatic encephalopathy and hepatorenal syndrome) o Child's B cirrhosis without decompensating events is not excluded * Current or history of hepatocellular carcinoma (HCC) * Current or history of portal vein thrombosis * Transjugular intrahepatic portosystemic shunt (TIPS) * Liver transplantation * Serious medical illness with limited life expectancy of less than 6 months * Pregnancy * Unable to obtain or refusal of informed consent from patient
Contact & Investigator
Jimmy Che-To Lai, MB ChB
PRINCIPAL INVESTIGATOR
Chinese University of Hong Kong
Frequently Asked Questions
Who can join the NCT06449339 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Portal Hypertension. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06449339 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06449339 currently recruiting?
Yes, NCT06449339 is actively recruiting participants. Contact the research team at angelchim@cuhk.edu.hk for enrollment information.
Where is the NCT06449339 trial being conducted?
This trial is being conducted at Hong Kong, Hong Kong.
Who is sponsoring the NCT06449339 clinical trial?
NCT06449339 is sponsored by Chinese University of Hong Kong. The principal investigator is Jimmy Che-To Lai, MB ChB at Chinese University of Hong Kong. The trial plans to enroll 474 participants.