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

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective Open Label Control Study to Evaluate the Efficacy and Safety of Entecavir Treatment of Patients With Acute on Chronic Hepatitis B Liver Failure

Conditions
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Liver Failure

Intervention / Treatment
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* Drug: entecavir
* Drug: Traditional comprehensive medical treatment


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control group<br>The patients were prescribed the tradition comprehensive medical treatment without entecavir. | Drug: Traditional comprehensive medical treatment<br>* bed rest, sufficient energy and vitamins, reduced glutathione, prostaglandin E1, hepatocyte growth factor (HGF), plasma and albumin, maintenance of water and electrolyte balance, and prevention and treatment of complications, such as infections, hepatic encephalopathy, hemorrhage, hepatorenal syndrome and ascites.<br>|
| Experimental: ETV group<br>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. | Drug: entecavir<br>* Patients in the ETV Group were prescribed 0.5 mg entecavir following oral fasting one time per day.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HBV DNA level and liver function | HBV DNA level,serum alanine transaminase (ALT), albumin (ALB), total bilirubin (TB), prothrombin time international normalize ratio （INR）， cholesterol (CHOL) | 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptoms,signs and mortality |  | 48 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hepatitis B, acute on chronic liver failure (ACHBLF), entecavir, treatment, predicting