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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
240
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.
Beijing Ditan Hospital Capital Medical University
Beijing, Beijing Municipality, China
RECRUITINGPeking University First Hospital
The progression incidence of esophageal varices after 4-year therapy
Progression of esophageal varices defines as follows: 1. Varices developed from small (F1) to medium or large (F2/F3) 2. Varices developed from medium (F2) to large (F3) 3. New-onset red sign without change in the degree of varices. 4. Bleeding from esophageal varices.
Time frame: 4-year
The incidence of liver cirrhosis decompensation
Cumulative rate of liver cirrhosis decompensation, including bleeding, ascites, hepatic encephalopathy, ect.
Time frame: 4-year
The incidence of hepatic cellular carcinoma, death or liver transplantation.
Cumulative rate of hepatic cellular carcinoma, death or liver transplantation.
Time frame: 4-year
The change of non-invasive assessment score reflecting liver fibrosis.
Higher scores mean a worse outcome.
Time frame: 4-year
The change of non-invasive assessment score reflecting liver function.
Higher scores mean a worse outcome.
Time frame: 4-year
The dynamic change of liver stiffness quantified by transient elastography.
The dynamic change of liver stiffness quantified by transient elastography.
Time frame: 4-year
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Beijing, Beijing Municipality, China
Peking University People's Hospital
Beijing, Beijing Municipality, China
RECRUITINGBeijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
RECRUITINGBeijing Ditan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
RECRUITINGBeijing Youan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
RECRUITINGAffiliated Hospital of Yanbian University
Yanji, Jilin, China
RECRUITINGZhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, China
RECRUITINGThe First Affiliated Hospital of Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, China
RECRUITINGShanghai Public Health Clinical Center
Shanghai, Shanghai Municipality, China
RECRUITING...and 4 more locations