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Entecavir for Patients With Decompensated Hepatitis B Virus (HBV)-Related Cirrhosis

Information source: Shanghai Changzheng Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hepatitis B Virus; Decompensated Cirrhosis

Intervention: Entecavir (Drug)

Phase: Phase 4

Status: Enrolling by invitation

Sponsored by: Shanghai Changzheng Hospital

Official(s) and/or principal investigator(s):
Jian Shi, MD, Principal Investigator, Affiliation: Shanghai Changzheng Hospital

Summary

The aim of this study is to evaluate the effect of Entecavir for patients With decompensated HBV-Related cirrhosis.

Clinical Details

Official title: Entecavir for Patients With Decompensated HBV-Related Cirrhosis:a Prospective Randomized Controlled Trial

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

liver function

HBV-DNA

Secondary outcome:

disease progression

hepatocellular carcinoma

Child-Pugh score

motality

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.

Eligibility

Minimum age: 16 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Shanghai changzheng Hospital, Shanghai, Shanghai 200003, China
Additional Information

Starting date: January 2008
Last updated: April 22, 2008

Page last updated: August 23, 2015

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