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Carvedilol has been shown to be more potent in decreasing portal hypertension to propranolol. But the efficacy of carvedilol to delay the growth of esophageal varices in chronic hepatitis B patients was unclear.
It has been concluded 40%-70% of chronic hepatitis B patients can achieve fibrosis/ cirrhosis reversion after effective anti-viral therapy. But there is still some patients progress to decompensation. Esophageal varices are the main complication of cirrhotic patients. Propranolol are widely used to prevent variceal bleeding in patients with large esophageal varices. It has been shown the efficacy of propranolol in the preventing of the progression from small to large varices reported no effect. Recently, carvedilol has been shown to be more potent in decreasing portal hypertension to propranolol. But the efficacy of carvedilol to delay the growth of esophageal varices in chronic hepatitis B patients was unclear. The purpose of this study is to demonstrate the efficacy of carvedilol in the preventing of the progression from small to large varices in hepatitis B patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Carvedilol+ Nucleos(t)ide Analogues | Experimental | Based on nucleoside analogue (NUCs), carvedilol will added to the patients. Carvedilol is started at a dose of 6.25 mg once daily. After 1 week, this will increased to a dose of 12.5 mg once daily. Target dose of 12.5 mg once daily will be maintained if systolic blood pressure does not fall below 90 mm Hg and HR 50 beats per minute. |
|
| Nucleos(t)ide Analogues | No Intervention | Continuing take nucleoside analogue (NUCs) including lamivudine (LAM), adefovir dipivoxil (ADV), entecavir (ETV), telbivudine (TBV), tenofovir disoproxil fumarate (TDF) and tenofovir alafenamide (TAF). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carvedilol | Drug | Carvedilol is started at a dose of 6.25 mg once daily. After 1 week, this will increased to a dose of 12.5 mg once daily. Target dose of 12.5 mg once daily will be maintained if systolic blood pressure does not fall below 90 mm Hg and HR 50 beats per minute. |
| Measure | Description | Time Frame |
|---|---|---|
| The progression Incidence of esophageal varices. | Progression of esophageal varices defines as follows:
| 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of liver cirrhosis decompensation | Cumulative rate of liver decompensation (including ascites,hepatic encephalopathy) after 2 year. | 2 years |
| The incidence of hepatic cellular carcinoma, death or liver transplantation. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xiaojuan Ou | Beijing Friendship Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Ditan Hospital Capital Medical University | Beijing | Beijing Municipality | 100015 | China | ||
| Peking University First Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37929952 | Derived | Wang B, Zhou J, Wu X, Sun Y, Li L, Li P, Li M, Jiang W, Xu M, Feng B, Xu X, Cheng J, Xie W, Han T, Wang X, Li H, Piao H, Zhao X, Chen S, Meng T, Guan Q, Meng F, Kong Y, Ou X, Jia J, You H. Carvedilol Plus NUC for Patients With HBV-Compensated Cirrhosis Under Virological Suppression: A Randomized Open-Label Trial. Am J Gastroenterol. 2024 Apr 1;119(4):700-711. doi: 10.14309/ajg.0000000000002569. Epub 2023 Nov 6. |
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| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| D006975 | Hypertension, Portal |
| D004932 | Esophageal and Gastric Varices |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D000077261 | Carvedilol |
| ID | Term |
|---|---|
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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Parallel Assignment
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|
Cumulative rate of hepatic cellular carcinoma, death or liver transplantation after 2 year.
| 2 years |
| The progression rate of non-invasive scores (Child-Pugh、MELD、APRI、FIB-4 score). | The progression rate of Child-Pugh、MELD、APRI、FIB-4 score after 2 years. | 2 years |
| The dynamic change of liver stiffness quantified by transient elastography. | The dynamic change of liver stiffness quantified by transient elastography after 2 years. | 2 years |
| The dynamic change of hemodynamics parameter | The dynamic change of hemodynamics (HR and mean arterial pressure) after 2 years. | 2 years |
| Beijing |
| Beijing Municipality |
| 100034 |
| China |
| Peking University People's Hospital | Beijing | Beijing Municipality | 100044 | China |
| Beijing Friendship Hospital | Beijing | Beijing Municipality | 100050 | China |
| Zhongshan Hospital Fudan University | Shanghai | Shanghai Municipality | 200032 | China |
| The First Affiliated Hospital of Shanghai Jiao Tong University | Shanghai | Shanghai Municipality | 201620 | China |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D020005 |
| Propanols |
| D000588 | Amines |
| D002227 | Carbazoles |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D006575 | Heterocyclic Compounds, 3-Ring |