Status:
UNKNOWN
Entecavir for Patients With Decompensated Hepatitis B Virus (HBV)-Related Cirrhosis
Lead Sponsor:
Shanghai Changzheng Hospital
Conditions:
Hepatitis B Virus
Decompensated Cirrhosis
Eligibility:
All Genders
16+ years
Phase:
PHASE4
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 acti...
Eligibility Criteria
Inclusion
- over 16 years of age;
- evidence of active viral replication was documented by a positive test for HBV-DNA in serum;
- Liver cirrhosis was proven by ultrasound or CT;
- Decompensated cirrhosis was evidenced by a Child-Pugh score ≥ 7;
- patients had decompensation signs such as jaundice, ascites, variceal bleeding, hepatic encephalopathy
Exclusion
- evidence of hepatocellular carcinoma (suspicious foci on hepatic ultrasonography at screening or a rising serum level of alpha-fetoprotein)
- a serum alanine aminotransferase level more than 10 times the upper limit of normal
- coinfection with hepatitis C or D virus or human immunodeficiency virus
- other types of cirrhosis
- a history of anti-viral therapy
- a total bilirubin level higher than 170 mmol/L
- a history of malignant tumors
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2012
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00663182
Start Date
January 1 2008
End Date
December 1 2012
Last Update
April 23 2008
Active Locations (1)
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1
Shanghai changzheng Hospital
Shanghai, Shanghai Municipality, China, 200003