Decompensated Cirrhosis, Hepatitis B Virus
Conditions
Keywords
Entecavir, cirrhosis, anti-viral, therapy
Brief summary
The aim of this study is to evaluate the effect of Entecavir for patients With decompensated HBV-Related cirrhosis.
Detailed description
Chronic hepatitis B is one of the most widespread viral infections worldwide, potentially leading to liver cirrhosis and hepatocellular carcinoma. Previous studies demonstrated that patients with active viral replication, defined as the presence of detectable serum HBV-DNA or HBeAg, were at increased risk of developing progressive liver disease or death.The prognosis of decompensated cirrhosis resulting from chronic hepatitis B virus infection is poor. Anti-viral therapy in decompensated HBV-related cirrhosis has been recommended by the American Association for the Study of Liver Diseases. However, no high quality research on the effectiveness of anti-viral therapy in decompensated cirrhosis has been performed. Entecavir is a new nucleotide analogue, which has been proved effective in suppressing viral replication and decreasing the necroinflammatory response, was recommended as a first-line medication in AASLD guideline. Our purpose was to evaluate the effect of Entecavir for patients With decompensated HBV-Related cirrhosis. The main outcomes were liver function, HBV-DNA, disease progression, hepatocellular carcinoma, Child-Pugh score and the survival.
Interventions
DRUGEntecavir
Entecavir 0.5 mg/d
Sponsors
Shanghai Changzheng Hospital
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. over 16 years of age; 2. evidence of active viral replication was documented by a positive test for HBV-DNA in serum; 3. Liver cirrhosis was proven by ultrasound or CT; 4. Decompensated cirrhosis was evidenced by a Child-Pugh score ≥ 7; 5. patients had decompensation signs such as jaundice, ascites, variceal bleeding, hepatic encephalopathy
Exclusion criteria
1. evidence of hepatocellular carcinoma (suspicious foci on hepatic ultrasonography at screening or a rising serum level of alpha-fetoprotein) 2. a serum alanine aminotransferase level more than 10 times the upper limit of normal 3. coinfection with hepatitis C or D virus or human immunodeficiency virus 4. other types of cirrhosis 5. a history of anti-viral therapy 6. a total bilirubin level higher than 170 mmol/L 7. a history of malignant tumors
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| liver function | 1 year |
| HBV-DNA | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| disease progression | 2 years |
| hepatocellular carcinoma | 2 year |
| Child-Pugh score | 2 year |
| motality | 2 year |
Countries
China
Outcome results
None listed