CirrhosisPhase 4CVL-NRNCT06594783
Carvedilol Plus EVL or Not for the Primary Prevention of Esophageal Variceal Bleeding in Carvedilol Non-responders
A Phase 4 study testing Carvedilol plus endoscopic variceal ligation and Carvedilol alone in people with Cirrhosis and Esophageal Varices, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial summary
The goal of this clinical trial is to evaluate whether carvedilol plus endoscopic variceal ligation (EVL) is more effective for the primary prevention of esophageal variceal bleeding than carvedilol alone in carvedilol non-responders. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Cirrhosis, Esophageal Varices
- What is being tested?
- Carvedilol plus endoscopic variceal ligation and Carvedilol alone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- 6 Jan 2025to Oct 2030
- Phase
- Phase 4
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cirrhotic patients with esophageal varices who, after carvedilol treatment, continue to experience variceal enlargement or develop new red color signs.
Who cannot join
- Age under 18 or over 90 years.
- History of esophageal variceal bleeding.
- Previous treatment for esophageal varices, including endoscopic variceal ligation, endoscopic sclerotherapy, transjugular intrahepatic portosystemic shunt, or surgery.
- Contraindications to non-selective beta-blockers, including severe atrioventricular block, chronic obstructive pulmonary disease (COPD), asthma, uncontrolled diabetes mellitus, or severe peripheral artery disease.
- Presence of end-stage organ diseases, including hepatocellular carcinoma or other terminal cancers, heart failure, or renal failure.
- Pregnant women.
- Refusal to participate in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Veterans General Hospital
Taipei, 11217
Tsung-Chieh Yang, MD, 886-2-28712121 ext. 7506, tcyang@vghtpe.gov.tw
Ming-Chih Hou, MD, 886-2-28712121 ext. 7053, mchou@vghtpe.gov.tw
About this study
Official title: Carvedilol Plus Endoscopic Ligation or Not for the Primary Prevention of Esophageal Variceal Bleeding in Carvedilol Non-responders: a Randomized Controlled Trial
The goal of this clinical trial is to evaluate whether carvedilol plus endoscopic variceal ligation (EVL) is more effective for the primary prevention of esophageal variceal bleeding than carvedilol alone in carvedilol non-responders. It will also learn about the safety of carvedilol combined with EVL in patients with cirrhosis.
The main questions it aims to answer are:
Read more
Whether carvedilol plus EVL is more effective than carvedilol alone in preventing the first esophageal variceal bleeding in cirrhotic patients unresponsive to carvedilol.
What medical problems do participants have when taking carvedilol or taking carvedilol combined with undergoing EVL? Researchers will compare the efficacy and safety of carvedilol with or without EVL in preventing the first esophageal variceal bleeding in cirrhotic patients unresponsive to carvedilol.
Participants will:
Take carvedilol every day (start from 6.25 mg/d and then titrate to 12.5 mg/d if tolerable) and undergo EVL every 3-4 weeks until variceal eradication followed by regular endoscopic follow-up according to the protocol, or Take carvedilol alone every day (start from 6.25 mg/d and then titrate to 12.5 mg/d if tolerable).
Visit the clinic once every 2-3 months for checkups and tests. Keep a diary of their vital signs (SBP, DBP, and HR) as well as symptoms.
Read the detailed description
Gastro-esophageal variceal bleeding is a major complication of portal hypertension and carries a high rate of rebleeding and mortality. How to prevent the first esophageal variceal bleeding (EVB) in patients with cirrhosis and portal hypertension has always been a very important issue. According to the latest Baveno VII consensus on the treatment of portal hypertension published in December 2021, nonselective beta-blockers (NSBB) should be used first to prevent decompensation in patients with clinically significant portal hypertension. Endoscopic variceal ligation (EVL) is recommended for compensated patients with high-risk esophageal varices (EVs) who have contraindications or an intolerance to NSBBs.
Carvedilol is a kind of NSBB and has extra intrinsic anti-α1 adrenergic activity. Carvedilol can reduce hepatic venous pressure gradient (HVPG) better than propranolol, and is currently the drug of choice for the primary prevention of EVB in patients with cirrhosis and CSPH. Although the HVPG-lowering effect of carvedilol is stronger than that of propranolol, up to 38-46% patients with CSPH are still carvedilol non-responders. Follow-up upper gastrointestinal endoscopy of these patients may show EVs become larger, more numerous, or have new red color signs, which indicate the increasing risk of EVB. However, studies discussing treatment options for patients with cirrhosis and EVs who do not respond to carvedilol therapy are scarce.
In this project, the investigators will initiate an open-label randomized controlled trial aiming at comparing the efficacy of carvedilol plus EVL or not for the primary prevention of EVB in cirrhotic patients who are carvedilol non-responders. The investigators will also explore if there is any difference between the two groups in terms of other upper gastrointestinal bleeding, non-bleeding liver decompensation (such as new onset/worsening ascites, hepatic encephalopathy, spontaneous bacterial peritonitis, and hepatorenal syndrome), overall survival, adverse events, tolerability and safety. The investigators will also analyze whether there is a difference of the two groups in preventing the first EVB in patients with varying degrees of cirrhosis who are carvedilol non-responders.
- Conditions
- Cirrhosis, Esophageal Varices
- Being tested
- Carvedilol plus endoscopic variceal ligation, Carvedilol alone
- Keywords
- Cirrhosis, Endoscopic variceal ligation, Nonselective beta-blocker, Portal hypertension
- Medical subject headings
- Fibrosis, Esophageal and Gastric Varices, Hypertension, Portal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carvedilol plus endoscopic variceal ligationOther
Take carvedilol every day (start from 6.25 mg/d and then titrate to 12.5 mg/d if tolerable) and undergo EVL every 3-4 weeks until variceal eradication followed by regular endoscopic follow-up according to the protocol.
Carvedilol aloneDrug
Take carvedilol alone every day (start from 6.25 mg/d and then titrate to 12.5 mg/d if tolerable).
| Study group | Role | What they receive |
|---|---|---|
| Carvedilol plus endoscopic variceal ligation | Active comparator | Take carvedilol every day (start from 6.25 mg/d and then titrate to 12.5 mg/d if tolerable) and undergo EVL every 3-4 weeks until variceal eradication followed by regular endoscopic follow-up according to the protocol. Receives: Other: Carvedilol plus endoscopic variceal ligation |
| Carvedilol alone | Placebo comparator | Take carvedilol alone every day (start from 6.25 mg/d and then titrate to 12.5 mg/d if tolerable). Receives: Drug: Carvedilol alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Esophageal variceal bleeding
The cumulative incidence of esophageal variceal bleeding
Measured: 3 years
Secondary outcomes (4)
Other upper gastrointestinal bleeding
The cumulative incidence of other upper gastrointestinal bleeding
Measured: 3 years
First/further nonbleeding liver decompensation
Events that defined first/further nonbleeding liver decompensation were based on the Baveno VII consensus.
Measured: 3 years
Overall survival
Measured: 3 years
Adverse events
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start6 Jan 2025
- Primary completionOct 2030 (estimated)
- Study completionOct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Carvedilol plus EVL group: Participants will take carvedilol every day (start from 6.25 mg/d and then titrate to 12.5 mg/d if tolerable) and undergo EVL every 3-4 weeks until variceal eradication followed by regular endoscopic follow-up according to the protocol. Carvedilol alone group: Patients will take carvedilol alone every day (start from 6.25 mg/d and then titrate to 12.5 mg/d if tolerable).
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06594783
- Sponsor's protocol ID
- 2024-08-017A
- Acronym
- CVL-NR
- Status last verified
- Feb 2025
- First submitted
- 10 Sep 2024
- Last updated
- 11 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chung CS, Chang PF, Liao CH, Lee TH, Chen Y, Lee YC, Wu MS, Wang HP, Ni YH. Differences of microbiota in small bowel and faeces between irritable bowel syndrome patients and healthy subjects. Scand J Gastroenterol. 2016;51(4):410-9. doi: 10.3109/00365521.2015.1116107. Epub 2015 Nov 23.
PubMed 26595305Fernandez M, Semela D, Bruix J, Colle I, Pinzani M, Bosch J. Angiogenesis in liver disease. J Hepatol. 2009 Mar;50(3):604-20. doi: 10.1016/j.jhep.2008.12.011. Epub 2008 Dec 31.
PubMed 19157625Fernandez M, Vizzutti F, Garcia-Pagan JC, Rodes J, Bosch J. Anti-VEGF receptor-2 monoclonal antibody prevents portal-systemic collateral vessel formation in portal hypertensive mice. Gastroenterology. 2004 Mar;126(3):886-94. doi: 10.1053/j.gastro.2003.12.012.
PubMed 14988842Schubert K, Olde Damink SWM, von Bergen M, Schaap FG. Interactions between bile salts, gut microbiota, and hepatic innate immunity. Immunol Rev. 2017 Sep;279(1):23-35. doi: 10.1111/imr.12579.
PubMed 28856736Wahlstrom A, Sayin SI, Marschall HU, Backhed F. Intestinal Crosstalk between Bile Acids and Microbiota and Its Impact on Host Metabolism. Cell Metab. 2016 Jul 12;24(1):41-50. doi: 10.1016/j.cmet.2016.05.005. Epub 2016 Jun 16.
PubMed 27320064Ridlon JM, Alves JM, Hylemon PB, Bajaj JS. Cirrhosis, bile acids and gut microbiota: unraveling a complex relationship. Gut Microbes. 2013 Sep-Oct;4(5):382-7. doi: 10.4161/gmic.25723. Epub 2013 Jul 12.
PubMed 23851335Wiest R, Lawson M, Geuking M. Pathological bacterial translocation in liver cirrhosis. J Hepatol. 2014 Jan;60(1):197-209. doi: 10.1016/j.jhep.2013.07.044. Epub 2013 Aug 28. No abstract available.
PubMed 23993913Baffy G. Potential mechanisms linking gut microbiota and portal hypertension. Liver Int. 2019 Apr;39(4):598-609. doi: 10.1111/liv.13986. Epub 2018 Nov 9.
PubMed 30312513Arab JP, Martin-Mateos RM, Shah VH. Gut-liver axis, cirrhosis and portal hypertension: the chicken and the egg. Hepatol Int. 2018 Feb;12(Suppl 1):24-33. doi: 10.1007/s12072-017-9798-x. Epub 2017 May 26.
PubMed 28550391Pande A, Kumar Sarin S, Jindal A, et al. Efficacy of carvedilol, endoscopic variceal ligation (EVL) or a combination for the prevention of first variceal bleed in child B and C cirrhosis with high risk varices: a randomized controlled trial. Hepatology 2019;v70:96A
Giuffre M, Dupont J, Visintin A, Masutti F, Monica F, You K, Shung DL, Croce LS; NSBB-Elasto-Response-Prediction Group. Predicting response to non-selective beta-blockers with liver-spleen stiffness and heart rate in patients with liver cirrhosis and high-risk varices. Hepatol Int. 2025 Apr;19(2):460-471. doi: 10.1007/s12072-024-10649-7. Epub 2024 Apr 25.
PubMed 38664292Bhardwaj A, Kedarisetty CK, Vashishtha C, Bhadoria AS, Jindal A, Kumar G, Choudhary A, Shasthry SM, Maiwall R, Kumar M, Bhatia V, Sarin SK. Carvedilol delays the progression of small oesophageal varices in patients with cirrhosis: a randomised placebo-controlled trial. Gut. 2017 Oct;66(10):1838-1843. doi: 10.1136/gutjnl-2016-311735. Epub 2016 Jun 13.
PubMed 27298379Wani ZA, Mohapatra S, Khan AA, Mohapatra A, Yatoo GN. Addition of simvastatin to carvedilol non responders: A new pharmacological therapy for treatment of portal hypertension. World J Hepatol. 2017 Feb 18;9(5):270-277. doi: 10.4254/wjh.v9.i5.270.
PubMed 28261384Merkel C, Bolognesi M, Sacerdoti D, Bombonato G, Bellini B, Bighin R, Gatta A. The hemodynamic response to medical treatment of portal hypertension as a predictor of clinical effectiveness in the primary prophylaxis of variceal bleeding in cirrhosis. Hepatology. 2000 Nov;32(5):930-4. doi: 10.1053/jhep.2000.19322.
PubMed 11050041Jachs M, Hartl L, Simbrunner B, Bauer D, Paternostro R, Balcar L, Hofer B, Pfisterer N, Schwarz M, Scheiner B, Stattermayer AF, Pinter M, Trauner M, Mandorfer M, Reiberger T. Carvedilol Achieves Higher Hemodynamic Response and Lower Rebleeding Rates Than Propranolol in Secondary Prophylaxis. Clin Gastroenterol Hepatol. 2023 Aug;21(9):2318-2326.e7. doi: 10.1016/j.cgh.2022.06.007. Epub 2022 Jul 14.
PubMed 35842118
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carvedilol Plus Endoscopic Ligation or Not for the Primary Prevention of Esophageal Variceal Bleeding in Carvedilol Non-responders: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06594783
- Acronym / sponsor ID
- CVL-NR / 2024-08-017A
- Conditions
- Cirrhosis, Esophageal Varices
- Keywords
- Cirrhosis, Endoscopic variceal ligation, Nonselective beta-blocker, Portal hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- 6 Jan 2025 (actual)
- Primary completion
- Oct 2030 (estimated)
- Study completion
- Oct 2030 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to evaluate whether carvedilol plus endoscopic variceal ligation (EVL) is more effective for the primary prevention of esophageal variceal bleeding than carvedilol alone in carvedilol non-responders. It will also learn about the safety of carvedilol combined with EVL in patients with cirrhosis.
The main questions it aims to answer are:
Whether carvedilol plus EVL is more effective than carvedilol alone in preventing the first esophageal variceal bleeding in cirrhotic patients unresponsive to carvedilol.
What medical problems do participants have when taking carvedilol or taking carvedilol combined with undergoing EVL? Researchers will compare the efficacy and safety of carvedilol with or without EVL in preventing the first esophageal variceal bleeding in cirrhotic patients unresponsive to carvedilol.
Participants will:
Take carvedilol every day (start from 6.25 mg/d and then titrate to 12.5 mg/d if tolerable) and undergo EVL every 3-4 weeks until variceal eradication followed by regular endoscopic follow-up according to the protocol, or Take carvedilol alone every day (start from 6.25 mg/d and then titrate to 12.5 mg/d if tolerable).
Visit the clinic once every 2-3 months for checkups and tests. Keep a diary of their vital signs (SBP, DBP, and HR) as well as symptoms.
Detailed description
Gastro-esophageal variceal bleeding is a major complication of portal hypertension and carries a high rate of rebleeding and mortality. How to prevent the first esophageal variceal bleeding (EVB) in patients with cirrhosis and portal hypertension has always been a very important issue. According to the latest Baveno VII consensus on the treatment of portal hypertension published in December 2021, nonselective beta-blockers (NSBB) should be used first to prevent decompensation in patients with clinically significant portal hypertension. Endoscopic variceal ligation (EVL) is recommended for compensated patients with high-risk esophageal varices (EVs) who have contraindications or an intolerance to NSBBs.
Carvedilol is a kind of NSBB and has extra intrinsic anti-α1 adrenergic activity. Carvedilol can reduce hepatic venous pressure gradient (HVPG) better than propranolol, and is currently the drug of choice for the primary prevention of EVB in patients with cirrhosis and CSPH. Although the HVPG-lowering effect of carvedilol is stronger than that of propranolol, up to 38-46% patients with CSPH are still carvedilol non-responders. Follow-up upper gastrointestinal endoscopy of these patients may show EVs become larger, more numerous, or have new red color signs, which indicate the increasing risk of EVB. However, studies discussing treatment options for patients with cirrhosis and EVs who do not respond to carvedilol therapy are scarce.
In this project, the investigators will initiate an open-label randomized controlled trial aiming at comparing the efficacy of carvedilol plus EVL or not for the primary prevention of EVB in cirrhotic patients who are carvedilol non-responders. The investigators will also explore if there is any difference between the two groups in terms of other upper gastrointestinal bleeding, non-bleeding liver decompensation (such as new onset/worsening ascites, hepatic encephalopathy, spontaneous bacterial peritonitis, and hepatorenal syndrome), overall survival, adverse events, tolerability and safety. The investigators will also analyze whether there is a difference of the two groups in preventing the first EVB in patients with varying degrees of cirrhosis who are carvedilol non-responders.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Carvedilol plus EVL group: Participants will take carvedilol every day (start from 6.25 mg/d and then titrate to 12.5 mg/d if tolerable) and undergo EVL every 3-4 weeks until variceal eradication followed by regular endoscopic follow-up according to the protocol. Carvedilol alone group: Patients will take carvedilol alone every day (start from 6.25 mg/d and then titrate to 12.5 mg/d if tolerable).
| Arm | Type | Receives |
|---|---|---|
| Carvedilol plus endoscopic variceal ligation | Active comparator | Other: Carvedilol plus endoscopic variceal ligationTake carvedilol every day (start from 6.25 mg/d and then titrate to 12.5 mg/d if tolerable) and undergo EVL every 3-4 weeks until variceal eradication followed by regular endoscopic follow-up according to the protocol. |
| Carvedilol alone | Placebo comparator | Drug: Carvedilol aloneTake carvedilol alone every day (start from 6.25 mg/d and then titrate to 12.5 mg/d if tolerable). |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Cirrhotic patients with esophageal varices who, after carvedilol treatment, continue to experience variceal enlargement or develop new red color signs.
Key exclusion criteria (7 listed)
- Age under 18 or over 90 years.
- History of esophageal variceal bleeding.
- Previous treatment for esophageal varices, including endoscopic variceal ligation, endoscopic sclerotherapy, transjugular intrahepatic portosystemic shunt, or surgery.
- Contraindications to non-selective beta-blockers, including severe atrioventricular block, chronic obstructive pulmonary disease (COPD), asthma, uncontrolled diabetes mellitus, or severe peripheral artery disease.
- Presence of end-stage organ diseases, including hepatocellular carcinoma or other terminal cancers, heart failure, or renal failure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carvedilol plus endoscopic variceal ligationTake carvedilol every day (start from 6.25 mg/d and then titrate to 12.5 mg/d if tolerable) and undergo EVL every 3-4 weeks until variceal eradication followed by regular endoscopic follow-up according to the protocol. | Other | Carvedilol plus endoscopic variceal ligation |
| Carvedilol aloneTake carvedilol alone every day (start from 6.25 mg/d and then titrate to 12.5 mg/d if tolerable). | Drug | Carvedilol alone |
Primary outcome
Esophageal variceal bleeding
Time frame: 3 years
The cumulative incidence of esophageal variceal bleeding
4 secondary outcomes
Other upper gastrointestinal bleeding
Time frame: 3 years
First/further nonbleeding liver decompensation
Time frame: 3 years
Overall survival
Time frame: 3 years
Adverse events
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2025.
- Background: PubMed 26595305Chung CS, Chang PF, Liao CH, Lee TH, Chen Y, Lee YC, Wu MS, Wang HP, Ni YH. Differences of microbiota in small bowel and faeces between irritable bowel syndrome patients and healthy subjects. Scand J Gastroenterol. 2016;51(4):410-9. doi: 10.3109/00365521.2015.1116107. Epub 2015 Nov 23.
- Background: PubMed 19157625Fernandez M, Semela D, Bruix J, Colle I, Pinzani M, Bosch J. Angiogenesis in liver disease. J Hepatol. 2009 Mar;50(3):604-20. doi: 10.1016/j.jhep.2008.12.011. Epub 2008 Dec 31.
- Background: PubMed 14988842Fernandez M, Vizzutti F, Garcia-Pagan JC, Rodes J, Bosch J. Anti-VEGF receptor-2 monoclonal antibody prevents portal-systemic collateral vessel formation in portal hypertensive mice. Gastroenterology. 2004 Mar;126(3):886-94. doi: 10.1053/j.gastro.2003.12.012.
- Background: PubMed 28856736Schubert K, Olde Damink SWM, von Bergen M, Schaap FG. Interactions between bile salts, gut microbiota, and hepatic innate immunity. Immunol Rev. 2017 Sep;279(1):23-35. doi: 10.1111/imr.12579.
- Background: PubMed 27320064Wahlstrom A, Sayin SI, Marschall HU, Backhed F. Intestinal Crosstalk between Bile Acids and Microbiota and Its Impact on Host Metabolism. Cell Metab. 2016 Jul 12;24(1):41-50. doi: 10.1016/j.cmet.2016.05.005. Epub 2016 Jun 16.
- Background: PubMed 23851335Ridlon JM, Alves JM, Hylemon PB, Bajaj JS. Cirrhosis, bile acids and gut microbiota: unraveling a complex relationship. Gut Microbes. 2013 Sep-Oct;4(5):382-7. doi: 10.4161/gmic.25723. Epub 2013 Jul 12.
- Background: PubMed 23993913Wiest R, Lawson M, Geuking M. Pathological bacterial translocation in liver cirrhosis. J Hepatol. 2014 Jan;60(1):197-209. doi: 10.1016/j.jhep.2013.07.044. Epub 2013 Aug 28. No abstract available.
- Background: PubMed 30312513Baffy G. Potential mechanisms linking gut microbiota and portal hypertension. Liver Int. 2019 Apr;39(4):598-609. doi: 10.1111/liv.13986. Epub 2018 Nov 9.
- Background: PubMed 28550391Arab JP, Martin-Mateos RM, Shah VH. Gut-liver axis, cirrhosis and portal hypertension: the chicken and the egg. Hepatol Int. 2018 Feb;12(Suppl 1):24-33. doi: 10.1007/s12072-017-9798-x. Epub 2017 May 26.
- BackgroundPande A, Kumar Sarin S, Jindal A, et al. Efficacy of carvedilol, endoscopic variceal ligation (EVL) or a combination for the prevention of first variceal bleed in child B and C cirrhosis with high risk varices: a randomized controlled trial. Hepatology 2019;v70:96A
- Background: PubMed 38664292Giuffre M, Dupont J, Visintin A, Masutti F, Monica F, You K, Shung DL, Croce LS; NSBB-Elasto-Response-Prediction Group. Predicting response to non-selective beta-blockers with liver-spleen stiffness and heart rate in patients with liver cirrhosis and high-risk varices. Hepatol Int. 2025 Apr;19(2):460-471. doi: 10.1007/s12072-024-10649-7. Epub 2024 Apr 25.
- Background: PubMed 27298379Bhardwaj A, Kedarisetty CK, Vashishtha C, Bhadoria AS, Jindal A, Kumar G, Choudhary A, Shasthry SM, Maiwall R, Kumar M, Bhatia V, Sarin SK. Carvedilol delays the progression of small oesophageal varices in patients with cirrhosis: a randomised placebo-controlled trial. Gut. 2017 Oct;66(10):1838-1843. doi: 10.1136/gutjnl-2016-311735. Epub 2016 Jun 13.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Carvedilol plus endoscopic variceal ligation and Carvedilol alone in people with Cirrhosis and Esophageal Varices, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
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 1 inclusion and 7 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 11 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Tsung-Chieh Yang, MD (886-2-28712121 ext. 7506, tcyang@vghtpe.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Esophageal variceal bleeding (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06594783, which also lists 26 linked publications.
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 11 Feb 2025.