Decompensated Cirrhosis Clinical Trial
Official title:
Entecavir for Patients With Decompensated HBV-Related Cirrhosis:a Prospective Randomized Controlled Trial
The aim of this study is to evaluate the effect of Entecavir for patients With decompensated HBV-Related cirrhosis.
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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