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Patients who have completed 2-years treatment in RCT Study of carvedilol will receive another 2-years extension therapy, aiming to investigate the long-term efficacy of carvedilol for the prevention of esophageal varices in treated HBV cirrhotic patients.
Carvedilol has been shown to be more potent in decreasing portal hypertension than propranolol. But the efficacy of carvedilol to prevent esophageal varices progression in nucleoside analogue (NUCs) treatment HBV related cirrhotic patients was unclear. Previous RCT study aimed to explore the effects of carvedilol for the prevention of the esophageal varices progression on HBV cirrhotic patients with anti-viral therapy has been conducted (NCT03736265). Patients who have completed 2-years treatment in RCT Study of carvedilol will receive another 2-years extension therapy, aiming to investigate the long-term efficacy of carvedilol for the prevention of esophageal varices in treated HBV cirrhotic patients. Patients were allocated according to the outcome of EDGs at 2-year during RCT study. Patients will be assessed at baseline and every six months for blood cell count, liver function test, HBVDNA, AFP, prothrombin time, liver ultrasonography, and Fibroscan. A third EGDs will be performed at 4-year.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Carvedilol+ NUCs therapy | Experimental | Patients randomized to Carvedilol combined with NUCs group during the previous 2-year treatment of RCT study; Patients showed the progression of esophageal varices in NUCs group during the 2-year treatment of RCT study. Based on nucleoside analogue (NUCs), carvedilol will be added to the patients. Carvedilol is started at a dose of 6.25 mg once per day, and will increase to a dose of 12.5 mg once per day after 1 week. Target dose will be maintained at 12.5 mg once per day if patients with systolic blood pressure not lower than 90 mm Hg and HR no less than 50 beats/min. |
|
| NUCs therapy | No Intervention | Continuing take single or combined 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 12.5 MG | Drug | Carvedilol is started at a dose of 6.25 mg once per day, and will increase to a dose of 12.5 mg once per day after 1 week. Target dose will be maintained at 12.5 mg once per day if patients with systolic blood pressure not lower than 90 mm Hg and HR no less than 50 beats/min. |
| Measure | Description | Time Frame |
|---|---|---|
| The progression incidence of esophageal varices after 4-year therapy | Progression of esophageal varices defines as follows:
| 4-year |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of liver cirrhosis decompensation | Cumulative rate of liver cirrhosis decompensation, including bleeding, ascites, hepatic encephalopathy, ect. | 4-year |
| The incidence of hepatic cellular carcinoma, death or liver transplantation. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaojuan Ou, Dr | Contact | +86-010-63138665 | ouxj16@126.com | |
| Xiaoning Wu, Dr | Contact | +86-010-63138665 | wuxiaoningbs@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiaojuan Ou | Beijing Friendship Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Ditan Hospital Capital Medical University | Recruiting | Beijing | Beijing Municipality | 100015 | China |
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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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|
|
Cumulative rate of hepatic cellular carcinoma, death or liver transplantation.
| 4-year |
| The change of non-invasive assessment score reflecting liver fibrosis. | Higher scores mean a worse outcome. | 4-year |
| The change of non-invasive assessment score reflecting liver function. | Higher scores mean a worse outcome. | 4-year |
| The dynamic change of liver stiffness quantified by transient elastography. | The dynamic change of liver stiffness quantified by transient elastography. | 4-year |
| Peking University First Hospital | Recruiting | Beijing | Beijing Municipality | 100034 | China |
|
| Peking University People's Hospital | Recruiting | Beijing | Beijing Municipality | 100044 | China |
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| Beijing Friendship Hospital, Capital Medical University | Recruiting | Beijing | Beijing Municipality | 100050 | China |
|
| Beijing Ditan Hospital, Capital Medical University | Recruiting | Beijing | Beijing Municipality | China |
|
| Beijing Youan Hospital, Capital Medical University | Recruiting | Beijing | Beijing Municipality | China |
|
| Affiliated Hospital of Yanbian University | Recruiting | Yanji | Jilin | China |
|
| Zhongshan Hospital Fudan University | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
|
| The First Affiliated Hospital of Shanghai Jiao Tong University | Recruiting | Shanghai | Shanghai Municipality | 201620 | China |
|
| Shanghai Public Health Clinical Center | Recruiting | Shanghai | Shanghai Municipality | China |
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| Tianjin Second People's Hospital | Recruiting | Tianjin | Tianjin Municipality | China |
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| Tianjin Third Central Hospital, Tianjin Medical University | Recruiting | Tianjin | Tianjin Municipality | China |
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| Tianjin Xiqing Hospital | Recruiting | Tianjin | Tianjin Municipality | China |
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| Xinjiang Uygur Autonomous Region Traditional Chinese Medicine Hospital | Recruiting | Xinjiang | Xinjiang | 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 |