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New treatment option for Portal Hypertension
Official title Non-selective Beta-blocker in Compensated Advanced Chronic Liver Disease
ClinicalTrials.gov ID: NCT06449339
What this study is testing
What is Carvedilol?
Carvedilol is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for portal hypertension.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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)
You likely can't join if
- 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...
- Contraindication to NSBB (e.g. Type II/III heart block or baseline bradycardia \<60/minute, hypotension with systolic blood pressure (SBP) \<100...
- 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...
See the full eligibility 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)
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Hong Kong, Hong Kong
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hong Kong, Hong Kong. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.