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

• Status: Unknown status
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Changzheng Hospital
• Treatments: Entecavir

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