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

Sun Yat-sen University

Status and phase: Completed; Phase 2

Conditions: Liver Failure

Treatments: Drug: Traditional comprehensive medical treatment; Drug: entecavir

Study type: Interventional

Funder types: Other

Identifiers

NCT01254994

Entecavir

Details and patient eligibility

About

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.

Enrollment: 108 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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108 participants in 2 patient groups

Control group

Active Comparator group

Description:

The patients were prescribed the tradition comprehensive medical treatment without entecavir.

Treatment:

Drug: Traditional comprehensive medical treatment

ETV group

Experimental group

Description:

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.

Treatment:

Drug: entecavir