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

Phase 4

• Conditions: Hepatitis B Virus; Decompensated Cirrhosis
• Interventions: Drug: Entecavir

• Registration Number: NCT00663182
• Lead Sponsor: Shanghai Changzheng Hospital

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.

Study Timeline

• Study Start: 2008-01
• Status Verified: 2008-04
• Study First Submitted: 2008-04-21
• Study First Submitted QC: 2008-04-21
• Study First Posted: 2008-04-22
• Last Update Submitted: 2008-04-22
• Last Update Posted: 2008-04-23
• Primary Completion: 2010-12
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	Entecavir	Patients with decompensated HBV-related cirrhosis

Primary Outcome Measures

Name	Time	Method
liver function	1 year
HBV-DNA	1 year

Secondary Outcome Measures

Name	Time	Method
disease progression	2 years
hepatocellular carcinoma	2 year
Child-Pugh score	2 year
motality	2 year

Trial Locations

Locations (1)

Shanghai changzheng Hospital; 🇨🇳 Shanghai, Shanghai, China