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

Phase 2

Completed

• Conditions: Liver Failure
• Interventions: Drug: Traditional comprehensive medical treatment; Drug: entecavir

• Registration Number: NCT01254994
• Lead Sponsor: Sun Yat-sen University

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2007-08
• Study Start: 2007-08
• Primary Completion: 2009-07
• Study Completion: 2010-12
• Study First Submitted: 2010-12-06
• Study First Submitted QC: 2010-12-06
• Last Update Submitted: 2010-12-06
• Study First Posted: 2010-12-07
• Last Update Posted: 2010-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Traditional comprehensive medical treatment	The patients were prescribed the tradition comprehensive medical treatment without entecavir.
ETV group	entecavir	All the patients were prescribed the tradition comprehensive medical treatment with entecavir. Entecavir was supplied by the Sino-US Shanghai Squibb Pharmaceutical Co., Ltd. Patients took 0.5 mg entecavir following oral fasting one time per day.

Primary Outcome Measures

Name	Time	Method
HBV DNA level and liver function	48 weeks	HBV DNA level,serum alanine transaminase (ALT), albumin (ALB), total bilirubin (TB), prothrombin time international normalize ratio （INR）， cholesterol (CHOL)

Secondary Outcome Measures

Name	Time	Method
Symptoms,signs and mortality	48 weeks

Trial Locations

Locations (1)

The Third Affiliated Hospital of Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China