The Efficacy and Safety of Entecavir Treatment of Patients With Acute on Chronic Hepatitis B Liver Failure

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate therapeutic efficacy and predicting factors of entecavir for treating patients with acute on chronic hepatitis B liver failure (ACHBLF). A total of 108 patients with ACHBLF were allocated into either a treatment group (ETV group, n=53) or a control group (n=55). The HBV DNA level, liver function and survival condition of the patients were observed for 48 weeks after enrollment. The factors possibly related to entecavir treatment efficacy were also identified.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University
• Treatments: Entecavir

Criteria

Inclusion Criteria:

• ACHBLF was diagnosed according to the criteria from the APASL in March 200815 and the program of Prevention and Cure for Viral Hepatitis and Liver Disease amended by the National Symposium on Viral Hepatitis and Liver Disease in September 2000.

• age >18 years

• HBV DNA > 3log10 copy/mL

Exclusion Criteria:

• Pregnant or lactating women.

• Diagnosed or suspected as hepatic carcinoma patients.

• Cases with any serious disease besides CHB, including heart disease, immunologic disease, malignant tumor, etc.

• Patients hypersensitive to nucleoside or nucleoside (acid) analogues or with a history nucleoside antiviral drug treatment.

• A history of drug abuse or alcohol abuse.

• Hepatic encephalopathy degree IV patients who were unable to take orally administered drugs.

• A history of using immunomodulator including steroids

• Conclusive evidence of other co infection s: anti-HAV-IgM positive, anti-HCV positive, anti-HEV positive, anti-HIV positive, autoimmunity liver diseases, Wilson disease, etc.