Liver cirrhosis patients: new drug may cut rebleeding risk
NCT ID NCT07352228
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether carvedilol, a newer blood pressure drug, works better than the standard drug propranolol for preventing another bleeding episode in people with liver cirrhosis who have already had variceal bleeding. Both drugs are given alongside a procedure to tie off swollen veins. The trial will enroll 350 adults aged 18-75 and follow them for up to 3 years to compare rebleeding rates and side effects.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 350 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2026
An estimate. Start dates often move.
- Expected to finish
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Oct 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Diagnosed with cirrhosis (based on previous liver biopsy or typical clinical features) with a history of variceal bleeding, and the most recent bleeding occurred 6-30 days before enrollment * Aged 18-75 years (based on ID card age on the enrollment date) * Voluntarily signs the informed consent form and can cooperate with full-course follow-up and related examinations Exclusion Criteria: * Non-cirrhotic portal hypertension (eg:Budd-Chiari syndrome, extrahepatic portal vein obstruction, idiopathic portal hypertension) * Contraindications to non-selective beta-blockers (NSBBs) (eg:asthma, insulin-dependent diabetes mellitus, peripheral vascular disease) * Malignant tumors (including hepatocellular carcinoma) or other life-shortening diseases (expected survival\<1 year), including severe cardio-cerebrovascular diseases (eg:severe heart failure, bedridden status after cerebral infarction, cerebral hemorrhage), end-stage renal disease (requiring dialysis), severe pulmonary diseases (eg:acute exacerbation of chronic obstructive pulmonary disease, pulmonary fibrosis)etc * Previous shunt or devascularization surgery, oral NSBBs, and/or endoscopic treatment for preventing recurrent variceal bleeding * Pregnant or lactating women (female subjects must undergo a pregnancy test before enrollment; positive cases are excluded; lactating women can only enroll after stopping breastfeeding) * Allergies to carvedilol, propranolol, or endoscopic treatment-related drugs (eg:local anesthetics, tissue adhesives) * Severe hepatic and renal insufficiency: Child-Pugh class C with a score \> 12, or MELD score \> 30; serum creatinine \> 221 μmol/L (2.5 mg/dl) with estimated glomerular filtration rate (eGFR) \< 30 ml/(min·1.73m²) * Severe coagulation disorders: prothrombin time (PT) prolonged by \> 10 seconds, or international normalized ratio (INR) \> 2.5 without effective correction measures
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The First Affiliated Hospital of Air Force Medical University
Xi'an, China
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Other studies related to the condition(s) this trial covers.
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